A Phase 2, Double-Blind, Placebo-Controlled Study to Determine the Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects With External Genital Warts
Phase: PHASE2
Conditions: Condylomata Acuminata, Papillomavirus Infections, Skin Diseases, Viral, Skin Diseases, Infectious, Skin Diseases, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Warts
Sponsor: Verrica Pharmaceuticals Inc.

NCT03981822
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
Page 1 
 
 
 
 
CLINICAL PROTOCOL 
 
 
 
TITLE OF STUDY 
 
CARE-1: A Phase 2, Double-Blind, Placebo-Controlled Study to Determine the 
Cantharidin Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects with 
External Genital Warts 
 
 
Protocol VP-102-104 
 
 
 
 
Version Number/Date of Issue: 
(Version 2) 07 August 2019 
Previous Version Number/Date of Issue: 
(Version 1) 09 May 2019 
Date of Original Protocol: 
09 May 2019 
Sponsor: 
Verrica Pharmaceuticals Inc. 
10 N. High Street, Suite 200 
West Chester, PA 19380 

NCT03981822
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
Page 2 
 
 
PROTOCOL APPROVAL 
 
Signatures of Approval of Protocol (Version 2) 
 
This protocol was subject to critical review and has been approved by the following persons: 
 
Affiliation 
Name 
Signature/Date 
Sponsor: 
 
 
08-Aug-2019 | 6:11 PM EDT 
Medical Monitor: 
 
 
08-Aug-2019 | 3:41 PM PDT 
Sponsor: 
Verrica Pharmaceuticals Inc. 
10 N. High Street; Suite 200 
West Chester, PA 19380 
 
Sponsor 
 Director Clinical 
Operations 10 N. High 
Street; Suite 200 
West Chester, PA 19380 
 
 
Medical 
Medical Monitor 
Paidion Research, Inc. 
240 Leigh Farm Road, Suite 175 
Durham, NC 27707 

NCT03981822
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
Page 3 
 
 
Acknowledgment of Responsibilities (Protocol Version 2) 
 
This protocol is the property of Verrica Pharmaceuticals Inc. I understand that the information 
within it is confidential and is provided to me for review by myself, my staff, and applicable ethics 
committees. I understand that the protocol must be kept in a confidential manner and must be 
returned to the Sponsor Verrica Pharmaceuticals Inc., or destroyed per Verrica Pharmaceuticals 
Inc. instructions, upon request. No part of this protocol may be reproduced in any form without 
permission from Verrica Pharmaceuticals Inc. By accepting this protocol, I agree that the 
information contained herein will not be disclosed to a third party without written authorization 
from Verrica Pharmaceuticals Inc. 
 
I have read and understood the protocol and agree that it contains all of the necessary information 
to carry out the study. 
 
I agree to conduct this trial in accordance with all stipulations of the protocol and in accordance 
with the following: Good Clinical Practice, the ethical principles that have their origin in the 
Declaration of Helsinki; Title 21 of the Code of Federal Regulations, Parts 50 (Protection of 
Human Subjects), and 56 (Institutional Review Boards), and 312 (Investigational New Drug 
Application); and International Council for Harmonisation E6 (Guideline for Good Clinical 
Practice). 
 
I agree that I will not modify this protocol without obtaining the prior approval of the Sponsor and 
of the institutional review board or independent ethics committee, except when necessary to 
protect the safety, rights, or welfare of subjects. 
 
 
Institution Name 
Investigator Name 
Signature 
Date 

NCT03981822
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
Page 4 
 
 
1.0 
PROTOCOL SYNOPSIS 
 
 
Name of sponsor company: Verrica Pharmaceuticals Inc. 
Name of finished product: VP-102 
Name(s) of active ingredient(s): Cantharidin 
Title of study: A Phase 2, Double-blind, Placebo-controlled Study to Determine the Cantharidin Dose 
Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects with External Genital Warts 
Number of sites: Up to nine sites (additional sites may be added if required to ensure successful 
recruitment of the study population) 
Study period: 
Part A: 147 Days; Part B: 147 Days 
Phase of development: Phase 2 
Objectives: 
Part A (Dose Regimen Finding) 
Primary objective: 
• 
To evaluate three regimens of application of VP-102 (2-hour, 6-hour, 24-hour duration of skin 
exposure) in subjects with external genital warts (EGW) and identify the two best regimens by 
assessing safety and tolerability of VP-102 when administered topically after all subjects have 
completed a 48-hour assessment. 
Primary efficacy objective: 
• 
To evaluate the efficacy of VP-102 when administered topically to EGW once every 21 days for up 
to 4 applications by assessing the proportion of subjects achieving complete clearance of all 
treatable warts (baseline and new) at the Study Day 84 End-of-Treatment (EOT) Visit 
Part B (Safety and Efficacy) 
Primary objective: 
• 
To evaluate two regimens of application of VP-102 in subjects with EGW and identify the regimen 
with the best risk:benefit profile when administered topically once every 21 days for up to 
4 applications. 
Part A & B (Safety and Efficacy) 
Secondary objectives: 
• 
To assess the safety and tolerability of VP-102 in subjects with EGW by evaluating adverse events 
(AEs) including expected local skin reactions (LSRs), vital signs, and concomitant medications 
• 
To evaluate the efficacy of VP-102 when administered topically to EGW once every 21 days for up 
to 4 applications by assessing the proportion of subjects achieving complete clearance of all 
treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and 
Follow-up Visits on Study Day 112 and Study Day 147 (End-of-Study [EOS]). 
• To evaluate the efficacy of VP-102 by assessing the change from baseline in the number of treatable 
warts (baseline and new) at each scheduled postbaseline visit 
• 
To evaluate the efficacy of VP-102 by assessing the percent change from baseline in the number of 
treatable warts (baseline and new) at each scheduled postbaseline visit 
• 
To evaluate the efficacy of VP-102 by assessing the proportion of subjects exhibiting 75% and 90% 
clearance of all treatable warts (baseline and new) at each scheduled postbaseline visit 

DocuSign Envelope ID: E77726CD-B745-46DC-88B9-FB9157EEB965 
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
PROTOCOL SYNOPSIS (continued) 
Page 5 
 
 
 
 
 
Name of sponsor company: Verrica Pharmaceuticals Inc. 
Name of finished product: VP-102 
Name(s) of active ingredient(s): Cantharidin 
Exploratory objectives: 
• 
To evaluate the efficacy of VP-102 by assessing the proportion of subjects exhibiting reduction of 
≥1 treatable wart from baseline at each scheduled postbaseline visit 
• 
To evaluate the efficacy of VP-102 by assessing the proportion of subjects who are clear at the 
Study Day 84 (EOT) Visit and remain clear at the Follow-up Visits on Study Day 112 and Study 
Day 147 (EOS). 
• 
To evaluate the efficacy of VP-102 by assessing the change from baseline in total wart area (sum 
of individual warts) at the scheduled post baseline visits Day 84, 112 and 147. 
• 
To evaluate the efficacy of VP-102 by assessing the percent change from baseline in total wart area 
(sum of individual warts) at the scheduled post baseline visits Day 84, 112 and 147. 
Methodology: This is a Phase 2, double-blind, placebo-controlled study to determine the dose regimen, 
safety, tolerability, and efficacy of VP-102 in subjects with EGW. 
This study is divided into two parts (Part A and Part B). The Schedule of Assessments and Procedures 
is presented in Table 1. 
Part A (dose regimen finding) study design: The aim of Part A is to determine the two best treatment 
regimens for evaluation of safety and efficacy in Part B. 
Treatment regimens will be evaluated based on the requirement to form blisters in most patients, while 
maintaining a favorable safety and tolerability profile (e.g., majority of LSR AEs are mild or moderate 
in severity). Accordingly, increasing durations of skin exposure to study drug (VP-102 or placebo) will 
be evaluated in three treatment groups (n=6/group) that will enroll progressively. 
Subjects will have a Screening Period of up to 14 days before the first treatment, followed by a Treatment 
Period starting at Treatment Visit 1 and lasting through Treatment Visit 4. 
Eighteen (18) subjects at up to six sites (additional sites may be added if required to ensure successful 
recruitment of the study population) will be enrolled, into either the 2-hour (Group 1), 6-hour (Group 2), 
or 24-hour (Group 3) treatment duration of skin exposure groups (n=6 subjects/group). Each group will 
include a minimum of two subjects from each sex and will be randomized 5:1 (VP-102:placebo) within 
each group. All subjects will receive either VP-102 (containing 0.7% cantharidin [w/v] topical film-
forming solution) or placebo. Warts are to be treated and then covered (unless prohibited by wart 
location) with transparent surgical tape (e.g., 3M™ Blenderm™ brand) that will remain on the skin until 
the designated time for removal. Subjects will be asked to remove the surgical tape and study drug with 
soap and water after the pre-determined duration of skin exposure for their group. 
Study drug (VP-102 or placebo) will be administered once every 21 ±4 days for up to four applications. 
Enrollment will begin in Group 1, then proceed into Group 2, and lastly into Group 3. The enrollment 
of subjects into Groups 2 and 3 will only be allowed upon completion of a blinded review of the safety 
and tolerability data by a Safety Review Panel. The Safety Review Panel will be responsible for 
reviewing blinded safety and tolerability data and will provide determinations on trial stopping or 
modification rules. A blinded review of treatment-emergent adverse events (TEAEs), focusing on those 
of moderate or severe intensity, will be performed by the Safety Review Panel before opening enrollment 

DocuSign Envelope ID: E77726CD-B745-46DC-88B9-FB9157EEB965 
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
PROTOCOL SYNOPSIS (continued) 
Page 6 
 
 
 
 
 
Name of sponsor company: Verrica Pharmaceuticals Inc. 
Name of finished product: VP-102 
Name(s) of active ingredient(s): Cantharidin 
for each subsequent cohort. This review will be conducted after the six subjects in a designated Group 
have completed the 48-hour (±8 hours) Visit. The Safety Review Panel will determine whether 
enrollment can be initiated into the next Group, OR if more data (e.g., waiting for additional treatments 
for enrolled subjects or the addition of more subjects to a group) are needed before making a 
determination to open enrollment into the next Group (i.e., the review conducted after six subjects have 
completed Group 1 could open enrollment into Group 2 and the review after Group 2 could open 
enrollment into Group 3). An additional blinded safety review of TEAEs, focusing on those of moderate 
or severe intensity, will be performed after all six subjects in Group 3 have completed the 48-hour 
(±8 hours) Visit, in order to support dose selection for Part B (Safety and Efficacy). Safety Review Panel 
members are blinded to the treatment assignment. 
Part B (safety and efficacy) study design: Part B of the study will begin enrollment only after the 
Sponsor has selected the two dose regimens in Part A, which will be called VP-102 Regimen 1 and 
Regimen 2. In addition, written notification from the Sponsor must be provided to the sites prior to Part B 
enrollment is to begin. The study will remain blinded until completion of both parts of the study. 
Approximately 90 subjects at up to 9 sites (additional sites may be added if required to ensure successful 
recruitment of the study population) will be enrolled and randomized to one of four treatment arms. 
Randomization will be stratified by sex so that neither gender exceeds ~60% of any treatment arm (e.g., 
placebo group for the 6-hour and 24-hour wash-off cannot have any one gender ≥ 60%). Two of the 
treatment arms will be VP-102 Regimen 1 and VP-102 Regimen 2. The other two treatment arms will 
be placebo (Placebo Regimen 1 and Placebo Regimen 2), with corresponding durations of skin exposure 
matching those selected for VP-102 Regimen 1 and Regimen 2. As an example, if the regimens selected 
from Part A are the 2-hour and 6-hour applications of VP-102, then VP-102 Regimen 1 would be VP-102 
treatment for 2-hours and VP-102 Regimen 2 would be VP-102 treatment for 6-hours. Likewise, Placebo 
Regimen 1 would be placebo treatment for 2 hours and Placebo Regimen 2 would be placebo treatment 
for 6-hours. Randomization of the four treatment arms (VP-102 Regimen 1:VP-102 Regimen 2:Placebo 
Regimen 1:Placebo Regimen 2) will be 3:3:2:2. 
In both Regimen 1 and Regimen 2, study drug will be administered to EGW once every 21 ±4 days for 
up to four applications. Subjects will be asked to remove the surgical tape and study drug with soap and 
water at the designated time selected from the dose regimen findings in Part A of the study. 
Part A and Part B subject participation: Pre-study screening for eligibility (informed consent, 
demographics, physical exam, vital signs, prior and concomitant medications, and medical history) can 
occur up to 14 days before, or on the same day as Treatment Visit 1. The dermatologic exam, wart count, 
wart measurement (diameter), location of all warts, and photographs (if applicable) must be repeated at 
Treatment Visit 1 if the Screening Visit is not conducted on the same day. Warts must measure ≤ 8 mm 
in diameter each with a total wart area (i.e., all warts combined) ≥ 10 mm2 at baseline. Wart count must 
be ≥ 2 and ≤ 30 total warts within the allowed treatment areas at the time of Treatment Visit 1. 
Subjects who do not continue to meet criteria at Treatment Visit 1 will be considered a screen failure 
and will be treated at physician discretion per standard of care. Subjects who meet the enrollment criteria 
will be randomized to receive VP-102 or placebo. Treatment will continue with a minimum of every 
21 ±4 days, until complete clearance or a maximum of four treatment sessions. The exact treatment 

DocuSign Envelope ID: E77726CD-B745-46DC-88B9-FB9157EEB965 
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
PROTOCOL SYNOPSIS (continued) 
Page 7 
 
 
 
 
 
Name of sponsor company: Verrica Pharmaceuticals Inc. 
Name of finished product: VP-102 
Name(s) of active ingredient(s): Cantharidin 
interval will be determined by evaluation of the treatment site and take any ongoing LSRs into account. 
Subjects who achieve complete clearance of all treatable warts before Treatment Visit 4 will be required 
to return for every scheduled, in-person, treatment and follow-up visit, whether or not their warts have 
cleared. The 24-hour, 7-day, and 14-day evaluation of response to treatment (ERT) telephone follow-ups 
will be conducted per protocol for those instances in which the subject was treated. 
Part A and Part B efficacy procedures 
All required study activities, including an ERT (i.e., assessment of wart activity [count, location, 
diameter] and related LSRs), will be conducted per protocol. A Blinded Assessor will perform wart 
counts before the ERT assessment at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, End of 
Treatment Visit, and Follow-up Visit. 
Treatment visits are to take place in order (i.e., Treatment 1, Treatment 2, Treatment 3, and Treatment 
4). All subjects will receive application of study drug to EGW, including an approximate margin of 
healthy surrounding skin, at an interval of every 21 ±4 days until complete clearance of all treatable 
warts, or a maximum of four applications. 
No partial treatment of warts (e.g., treating one wart and not another) is permitted. In any instance where 
the clinician is uncertain if a residual wart is remaining, treatment should be applied. Instructions for 
application of the study drug are outlined in the Instructions for Use included in the drug shipment, as 
well as included in the Site Regulatory Packet. 
Subjects should be re-treated only after 17 to 25 days (i.e., 21 ±4 days) have elapsed since the previous 
treatment and only after any LSRs have resolved sufficiently to allow evaluation of the treatment site. 
Treatment should only take place at a visit when all warts are evaluable (i.e., not obscured by an ongoing 
LSR). All warts that are not completely clear should undergo treatment with study drug. Subjects 
exhibiting skin reactions that need additional time, at the Investigator’s discretion, before they can be 
treated again will be evaluated and asked to return for their next treatment visit after the area is 
considered sufficiently resolved to allow for the next treatment (e.g., ongoing dryness or erythema is 
appropriate to treat). See instructions below regarding unscheduled visits. 
Subjects who receive <4 treatments within the treatment period, or have visits that are outside of the 
visit window due to the duration of post-treatment LSRs, will not be considered a protocol deviation. In 
the event that a subject misses a treatment visit, and is outside the 4-day study window, they may return 
and be treated at the next available opportunity with the subsequent visit scheduled 21 ±4 days after the 
actual treatment visit. No treatment should be administered after the treatment period without the 
Sponsor’s approval. 
An ERT assessment will be conducted at each treatment visit (1-4; in-person before treatment or via 
follow-up telephone calls) at 24 hours (±6 hours), 7 days (±24 hours), and 14 days (±24 hours) after each 
treatment visit (but not after “unscheduled” visits). Note that the ERT telephone calls at 24 hours 
(±6 hours), 7 days (±24 hours) and 14 days (±24 hours) are not required if there was no treatment during 
that period. In Part A Treatment Period 1 only, subjects will return to the clinic for an in-person ERT 
assessment at 48 hours (±8 hours) after Treatment Visit 1. The ERT includes questions related to removal 
of surgical tape and study drug (if applicable) and collects any new AEs, LSRs, or changes in 

DocuSign Envelope ID: E77726CD-B745-46DC-88B9-FB9157EEB965 
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
PROTOCOL SYNOPSIS (continued) 
Page 8 
 
 
 
 
 
Name of sponsor company: Verrica Pharmaceuticals Inc. 
Name of finished product: VP-102 
Name(s) of active ingredient(s): Cantharidin 
concomitant medications since the last contact. The subject will be given an opportunity to ask questions 
and review any concerns. In the event that any post-treatment LSR presents a safety concern (including 
but not limited to severe blistering, ulceration, edema, or pain), an “Unscheduled” clinic visit must be 
scheduled and the subject assessed accordingly. In addition, if any post-treatment AEs present a safety 
concern, the subject may be brought in for an unscheduled visit. The ERT assessments will be recorded 
by a research team member on the ERT form. The ERT visits may not be conducted by a person 
designated as a Blinded Assessor. Phone calls conducted outside of the required study visits or required 
ERT assessments should be documented in the subject’s source note but are not required to be entered 
in the electronic data capture system. 
ERT assessments, wart count, and wart location will be conducted before treatment application at all 
Treatment Visits 1 to 4, as well as at the EOT Visit on Study Day 84 (–0/+8 days) and at the Follow-up 
Visits on Study Day 112 (±7 days) and Study Day 147 (±7 days). Wart measurement will be conducted 
before treatment application at Treatment Visit 1, as well as at the EOT Visit on Study Day 84 (-
0/+8 days) and at the Follow-up Visits on Study Day 112 (±7 days) and Study Day 147 (±7 days). 
Subjects who clear all warts before the Study Day 84 (EOT) Visit will still be required to return for each 
of the scheduled in-person treatment visits, as well as the Study Day 84 (EOT) Visit, the Study Day 112 
follow-up visit, and the Study Day 147 (EOS) Visit. A Provider Treatment Questionnaire will be 
completed at the Study Day 84 (EOT) Visit by a clinician who applied treatment to the subject during 
the course of the study. All subjects will continue in the study for two additional Follow-up Visits on 
Study Day 112 and Study Day 147 (EOS). 
All treatment visits will include a wart count, performed before treatment (if applicable) and before ERT 
assessment. No treatment will be required if the wart is considered clear. Genital warts that develop in 
areas that are unable to be treated, (e.g., close to a mucous membrane) and other wart types (e.g., 
common warts) will not be evaluated, documented, or considered in the analysis. 
Wart counts will be conducted at Screening, Treatment 1, Treatment 2, Treatment 3, Treatment 4, End 
of Treatment and Follow-up Visits by a trained member of the study team. Other than the screening visit 
and Day 1, wart counts will also be conducted by a member of the research team that has been identified 
and trained as a Blinded Assessor. The Blinded Assessor may be utilized for a subject’s initial screening, 
enrollment and treatment Visit 1 activities, however, may not perform any other study related activities 
other than wart counts at subsequent visits (e.g., follow-up phone calls or unscheduled visits) for the 
same subject. The Blinded Assessor is not required to be the same person for each assessment. 
It can sometimes be challenging to determine if a wart is completely clear after treatment due to ongoing 
LSRs. At any visit in which the Investigator is unable to evaluate or treat some warts due to ongoing 
LSRs, an “Unscheduled” visit should be documented. The timing of the next visit will be determined by 
the resolution of the LSR. The research team should be in contact with the patient until LSRs are resolved 
sufficiently and a treatment visit can be scheduled within 21 ±4 days when possible. Specific instructions 
on how to conduct the initial wart count and measure wart diameter will be provided during Investigator 
training. 
At designated sites, photography will be offered to volunteer subjects who consent to participate. 

DocuSign Envelope ID: E77726CD-B745-46DC-88B9-FB9157EEB965 
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
PROTOCOL SYNOPSIS (continued) 
Page 9 
 
 
 
 
 
Name of sponsor company: Verrica Pharmaceuticals Inc. 
Name of finished product: VP-102 
Name(s) of active ingredient(s): Cantharidin 
Part A and Part B safety procedures 
Subjects will be provided with take home instructions describing what they might expect throughout the 
course of the study, as well as recommendations for wound care (if needed), when it is important to call 
their doctor, and instructions for who to contact in an emergency. In the event that any post-treatment 
LSR presents a safety concern (including but not limited to severe blistering, ulceration, edema, or pain), 
an “Unscheduled” clinic visit must be scheduled and the subject assessed accordingly. In addition, if any 
post-treatment AEs present a safety concern, the subject may be brought in for an unscheduled visit. 
An LSR guide for subjects, with specific photographs representing the various skin reactions and 
examples of intensity, will be provided and reviewed in detail at the clinic with the subject by the 
research team. The LSR guide will be utilized for reference by the subject during the ERT follow-up 
telephone assessments with the research team member. The final determination of LSR parameters, 
including intensity, will be made by the research team member. 
Subject Participation: Pre-study screening for eligibility (informed consent, demographics, physical 
exam, vital signs, prior and concomitant medications, and medical history) can occur up to 14 days 
before, or on the same day as Treatment Visit 1. The dermatologic exam, wart count, wart measurement 
(diameter), location of all warts, and photographs (if applicable) must be repeated at Treatment Visit 1 
if the Screening Visit is not conducted on the same day. Warts must measure ≤ 8 mm in diameter each 
with a total wart area (i.e., all warts combined) ≥ 10 mm2 at baseline. Wart count must be ≥ 2 and ≤ 30 
total warts within the allowed treatment areas at the time of Treatment Visit 1. 
Subjects who do not continue to meet criteria at Treatment Visit 1 will be considered a screen failure 
and will be treated at physician discretion per standard of care. Subjects who meet the enrollment criteria 
will be randomized to receive VP-102 or placebo. Treatment will continue with a minimum of every 
21 ±4 days, until complete clearance or a maximum of four treatment sessions. The exact treatment 
interval will be determined by evaluation of the treatment site and take any ongoing LSRs into account. 
Subjects who achieve complete clearance of all treatable warts before Treatment Visit 4 will be required 
to return for every scheduled, in-person, treatment and follow-up visit, whether or not their warts have 
cleared. The 24-hour, 7-day, and 14-day ERT telephone follow-ups will be conducted per protocol for 
those instances in which the subject was treated. 

DocuSign Envelope ID: E77726CD-B745-46DC-88B9-FB9157EEB965 
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
PROTOCOL SYNOPSIS (continued) 
Page 10 
 
 
 
 
 
Name of sponsor company: Verrica Pharmaceuticals Inc. 
Name of finished product: VP-102 
Name(s) of active ingredient(s): Cantharidin 
Inclusion Criteria: 
To qualify for inclusion in this study, subjects must: 
1. Be healthy, immunocompetent males or females ≥ 18 years of age 
2. Present with ≥ 2 and ≤ 30 external genital and/or perianal warts in ≥ 1 of the following anatomic 
areas: 
– In both sexes: medial thigh (except inguinal fold); supra-pubic, perineal, and perianal areas 
– 
In men: over the glans penis (excluding urethral meatus), penis shaft, scrotum, and foreskin 
– 
In women: vulva (excluding labia minora and mucosal surfaces) 
3. Have warts present for ≥ 4 weeks at the baseline visit 
4. Have warts that are ≤ 8 mm in diameter each with a total wart area (i.e., all warts combined) 
≥ 10 mm2 
5. Be free of any systemic or dermatologic disorder, that, in the opinion of the Investigator, will 
interfere with the study conduct, efficacy assessments, or increase the subject’s risk of AEs 
6. Refrain from swimming, bathing, or prolonged immersion in water or any other liquids until the 
study drug is removed 
7. Have the ability to follow study instructions and be likely to complete all study requirements 
8. Agree to use no wart-removing product (prescription or over-the-counter, including any human 
papilloma virus [HPV] immunization) other than the study drug during the course of the study 
9. Provide written informed consent in a manner approved by the Institutional Review Board (IRB) 
and evidenced by the signature on an IRB approved consent form 
10. Provide written authorization for use and disclosure of protected health information 
11. If participating in the optional photographic portion of the study, agree to allow photographs of 
warts to be taken at each treatment and all follow-up visit by the research team 
Exclusion Criteria: 
Candidates will be excluded from the study if they: 
1. Are unable to cooperate with the requirements or visits of the study, as determined by the 
Investigator 
2. Have a wart within the allowed treatment area > 8 mm in diameter or with an eroded or ulcerated 
surface, in the Investigator’s opinion 
3. Have an unclear diagnosis of condyloma 
4. Have warts outside of the allowed treatment area (e.g., cervical, vaginal, clitoral, rectal, within 2 
mm of anus) that require treatment during the planned study period or are undergoing treatment in 
the last 4 weeks 
5. Have any wart types other than genital warts (e.g., common or plantar warts) that require treatment 
during the study period 
6. Have a history of genital infections or diseases within 4 weeks before enrollment 
7. Have active genital herpes eruption, or had active genital herpes lesions within 4 weeks before 
enrollment 
8. Have a history of HPV-associated malignancies within the last 5 years 

DocuSign Envelope ID: E77726CD-B745-46DC-88B9-FB9157EEB965 
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
PROTOCOL SYNOPSIS (continued) 
Page 11 
 
 
 
 
 
Name of sponsor company: Verrica Pharmaceuticals Inc. 
Name of finished product: VP-102 
Name(s) of active ingredient(s): Cantharidin 
9. Have a dermatologic disease (e.g., psoriasis) or skin condition in the wart areas that may cause 
difficulty with examination 
10. Are systemically immunosuppressed or have required, or will require, systemic immunosuppressive 
or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days before 
enrollment or during the course of the study (routine use of local [e.g., topical, inhaled, or intranasal] 
corticosteroids during the study is allowed) 
11. Have any chronic or acute medical condition that, in the opinion of the Investigator, may interfere 
with the study results or place the subject at undue risk (e.g., human immunodeficiency virus, 
systemic lupus erythematosus, viral hepatitis, diabetes, clinically significant medical, psychiatric, 
or emotional condition or abnormality). 
12. Have had HPV immunization within the last 3 months prior to enrollment. (NOTE: HPV may NOT 
be administered during the course of the trial. Other immunizations (e.g., flu shots) may be 
administered throughout the study, but not within 5 days before or after treatment. 
13. Have had any previous treatment (including an investigational agent in a clinical trial) of genital 
warts, including but not limited to the use of imiquimod, antivirals, retinoids, salicylic acid, lactic 
acid, hydrogen peroxide, iodine-based or nitric oxide-based therapies, curettage, or freezing of warts 
in the 14 days before screening; in addition, these treatments, or any other over-the-counter wart 
treatment, should not be implemented during the study. The wash-out period for cantharidin, 
candida antigen, diphencyprone, dinitrochlorobenzene, squaric acid dibutyl ester, and any other 
immunomodulating treatment not otherwise specified is 30 days before the screening visit. 
14. Have history of, or current, epidermodysplasia verruciformis 
15. Have an active malignancy or are undergoing treatment for any malignancy 
16. Have a history or presence of hypersensitivity or an idiosyncratic reaction to VP-102 (including 
cantharidin or related compounds) or study drug product excipients (acetone, ethyl alcohol, 
nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and denatonium 
benzoate) 
17. Have a condition or situation that may interfere significantly with the subject’s participation in the 
study (e.g., subjects who required hospitalization within 2 months before screening for an acute or 
chronic condition including alcohol or drug abuse), at the discretion of the Investigator 
18. Are sexually active or may become sexually active and are unwilling to practice responsible birth 
control methods (e.g., birth control pills, intrauterine device, patch, shot, vaginal ring, and 
combination of condoms and foam); NOTE that withdrawal and/or sterilization of self or partner 
are not acceptable methods of birth control. Females that have reached menarche must have a 
negative urine pregnancy test at each study visit before treatment with study drug 
19. Are pregnant or breastfeeding 

DocuSign Envelope ID: E77726CD-B745-46DC-88B9-FB9157EEB965 
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
PROTOCOL SYNOPSIS (continued) 
Page 12 
 
 
 
 
 
Name of sponsor company: Verrica Pharmaceuticals Inc. 
Name of finished product: VP-102 
Name(s) of active ingredient(s): Cantharidin 
Test Product, Dose, and Mode of Administration: Study drug (VP-102 or placebo) is contained within 
a single-use applicator. Study drug will be applied in sufficient quantity to cover the entirety of each 
wart including approximately a 1 mm margin of surrounding, healthy skin. The VP-102 single-use 
applicator contains 0.45 mL of 0.7% w/v cantharidin, (Lot # 108107172). 
The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not 
contain the active pharmaceutical ingredient cantharidin (Lot # 108207171.) 
Duration of Treatment: Study duration from Treatment Visit 1 through the final follow-up visit is 
approximately 147 days (21 weeks). The length of study participation is approximately 84 (–0/+8) days 
for the EOT assessment (primary endpoint) and Study Day 147 (±7 days) to complete the study, in 
addition to the screening visit of up to 14 days before study drug administration. The study will consist 
of up to four applications of study drug at intervals of 21 ±4 days. All treatments will take place within 
a 75-day period. No treatment should be administered after Day 75 without the Sponsor’s approval. 
Post-treatment Follow-up Visits on Study Day 84 (–0/+8 days) (EOT), Study Day 112 (±7 days),), and 
Study Day 147 (±7 days) are included for subjects to evaluate the durability of treatment response over 
time. 
Criteria for Evaluation 
Primary efficacy endpoint: 
• 
Proportion of subjects exhibiting complete clearance of all treatable warts at the Study Day 84 
(EOT) Visit 
Secondary efficacy endpoints: 
• 
Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at 
Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 
and Study Day 147 (EOS) 
• 
Proportion of subjects exhibiting 90% and 75% clearance of all treatable warts (baseline and new) 
at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up 
Visits on Study Day 112 and Study Day 147 (EOS) 
• 
Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, 
Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 
and Study Day 147 (EOS) 
• 
Change from baseline in the percent of treatable warts (baseline and new) at Treatment Visit 2, 
Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 
112 and Study Day 147 (EOS) 

DocuSign Envelope ID: E77726CD-B745-46DC-88B9-FB9157EEB965 
CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
PROTOCOL SYNOPSIS (continued) 
Page 13 
 
 
 
 
 
Name of sponsor company: Verrica Pharmaceuticals Inc. 
Name of finished product: VP-102 
Name(s) of active ingredient(s): Cantharidin 
Exploratory efficacy endpoints: 
• 
Proportion of subjects exhibiting reduction of ≥ 1 treatable wart from baseline at Treatment Visit 2, 
Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 
and Study Day 147 (EOS) 
• 
Proportion of subjects who are clear at the Study Day 84 (EOT) Visit and remain clear at the Follow- 
up Visits on Study Day 112 and Study Day 147 (EOS) 
• 
Change from baseline in total wart area (sum of individual warts) at Study Day 84 (EOT), and 
Follow-up Visits on Study Day 112 and Study Day 147 (EOS) 
• 
Change from baseline in the percent of total wart area (sum of individual warts) at Study Day 84 
(EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) 
Safety endpoints: 
Safety analyses will include AEs, LSRs, medical history (including previous HPV immunization), 
physical examinations, vital signs, and concomitant medication use 
• 
The incidence of AEs will be assessed throughout the study; AEs will include all LSRs, whether or 
not they are expected or related to study drug mechanism of action. 
• 
LSRs of all previously treated areas will be assessed at each treatment visit using the protocol 
specific ERT form 
• 
Limited physical examinations will be completed before the first treatment and at the Study Day 
147 (EOS) Visit; additional physical examinations will be performed when clinically warranted 
(e.g., subject reports symptoms classified as an AE requiring further evaluation) 
• 
Vital signs (temperature and heart rate) will be obtained before the treatment is applied at each 
treatment visit and at the start of the Study Day 84 (EOT) Visit 
• 
Concomitant medication use will be collected at each study visit and ERT telephone contact 
Statistical Methods: 
Although no formal power calculations have been performed, it is expected that a sample size of 
18 subjects in Part A and 90 subjects in Part B, evaluable at the Study Day 84 (–0/+8 days) EOT Visit, 
will be informative regarding wart clearance rates that can support assumptions in subsequent placebo- 
controlled trials. 
Analysis populations: 
• 
The Intent-to-Treat (ITT) Population will include all randomized subjects 
• 
The Safety Population will include all randomized subjects who receive ≥ 1 application of study 
drug (VP-102 or placebo) 

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CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
PROTOCOL SYNOPSIS (continued) 
Page 14 
 
 
 
 
 
Name of sponsor company: Verrica Pharmaceuticals Inc. 
Name of finished product: VP-102 
Name(s) of active ingredient(s): Cantharidin 
• 
The Per-Protocol (PP) Population will include all subjects who receive all planned treatments of 
study drug (e.g., complete up to four treatments within the Day 75 treatment window or clear before 
Day 75), had no major protocol violations, and were assessed for clearance at the Study Day 84 (-
0/+8 days) EOT Visit 
Summaries of data from subjects enrolled in Part A will be pooled with corresponding subjects in Part B. 
For instance, if one of the two regimens selected for Part B is the 6-hour application of VP-102, then 
results from subjects who received the 6-hour application of VP-102 from Part A will be pooled with 
results from subjects who received the 6-hour application of VP-102 from Part B. 
An additional set of tables will be generated that summarize subjects from Part A of the study who are 
not used in Part B of the study. Summary statistics for continuous variables and counts and percentages 
for categorial variables will be shown by treatment. However, due to the limited number of subjects for 
this set of tables (expected n=6), analyses to be carried out will only be descriptive in nature. 
Subject demographics, efficacy tables, and subject dropout rates will be tabulated at the Study Day 84 
(EOT) Visit and Study Day 147 (EOS) Visit. Data will be summarized using descriptive statistics 
(sample size, mean, median, standard deviation, minimum, maximum) for continuous variables and 
frequencies, and percentages for discrete variables. Corresponding by-subject data listings will be 
tabulated. 
Efficacy will be evaluated in the ITT and PP Population by treatment group. At the end of the study, 
tables will be generated that pool subjects from Part A and Part B for VP-102 Regimen 1, VP-102 
Regimen 2, Placebo Regimen 1, and Placebo Regimen 2. For the efficacy endpoints, summary statistics 
for continuous variables and counts and percentages for categorical variables will be presented. In 
addition, statistical comparisons will be carried out to compare VP-102 Regimen 1 to Placebo Regimen 
1 and VP-102 Regimen 2 to Placebo Regimen 2. Comparisons made within Regimen 1 (VP-102 vs 
Placebo) will be independent of comparisons made within Regimen 2. Comparisons may be carried 
across Regimens; however, no formal statistical testing will be carried out with comparisons being 
considered only observational. 
An additional set of tables will be generated that summarize subjects from Part A of the study who do 
not participate in Part B of the study. Summary statistics for continuous variables and counts and 
percentages for categorial variables will be shown by treatment. However, due to the limited number of 
subjects for this set of tables (expected n=6), analyses to be carried out will only be descriptive in nature. 
Safety analyses will be conducted in the Safety Population by actual treatment received. AEs, including 
LSRs, will be coded with the Medical Dictionary for Regulatory Activities (MedDRA®) Version 20.0. 
The number and percentage of subjects having TEAEs will be tabulated by system organ class and 
MedDRA preferred term with a breakdown by treatment group. A subject-by-subject AEs data listing, 
including verbatim term, preferred term, treatment, severity, location, and causal relationship to the study 
drug will be provided. The number of subjects experiencing TEAEs and number of TEAEs will be 
summarized by treatment using frequency counts. 

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Clinical Protocol 
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Table 1. 
Study Schedule of Assessments and Procedures (Part A and Part B) 
Period 
Screen 
Treatment Period 1 
Treatment Period 2 
Treatment Period 3 
Treatment Period 4 
Follow-up and 
Unscheduled Visits 
Task 
Screena 
Tx 
1 
ERT 
Phone 
Call 
ERT 
In- 
person 
(Part 
A 
only) 
ERT 
Phone 
Call 
Tx 
2 
ERTb 
Phone 
Call 
ERTb 
Phone 
Call 
Tx 
3 
ERTb 
Phone 
Call 
ERTb 
Phone 
Call 
Tx 
4 
ERTb 
Phone 
Call 
ERTb 
Phone 
Call 
EOTc 
Follow 
-up 
Unsched- 
uledd 
Study Day 
Post-treatment 
time for each 
period 
-14 to 1 
1 
24±6 
hours 
48±8 
hours 
7 and 
14 days 
(±24 
hours) 
1e 
24±6 
hours 
7 and 
14 days 
(±24 
hours) 
1e 
24±6 
hours 
7 and 14 
days 
(±24 
hours) 
1e 
24±6 
hours 
7 and 
14 days 
(±24 
hours) 
84 
(-0/+8 
days) 
112, 147 
(EOS)f 
(±7 days) 
Informed consent/ 
authorization 
X 
Inclusion/ 
exclusion criteria 
X 
X 
Demographicsg 
X 
Height and weight 
X 
X 
X 
Prior relevant 
medical history, 
including HPV 
immunization 
X 
X 
Wart History 
X 
X 
Vital signs (T/P)h 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical exami 
X 
X 
Wart count j 
(BA only) 
X 
X 
(X) 
(X) 
(X) 
(X) 
(X) 
Wart location j 
X 
X 
X 
X 
X 
X 
X 
Wart measurement 
j 
X 
X 
X 
X 
Dermatologic 
exam (includes 
Fitzpatrick at 
screen only) j 
X 
X 
X 
X 
X 
X 
X 
X 

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VP-102 (Cantharidin) 
VP-102-104 
Clinical Protocol 
Table 1. 
Study Schedule of Assessments and Procedures (Part A and Part B) (continued) 
Page 16 
 
 
 
 
 
 
Period 
Screen 
Treatment Period 1 
Treatment Period 2 
Treatment Period 3 
Treatment Period 4 
Follow-up and 
Unscheduled Visits 
Task 
Screena 
Tx 
1 
ERT 
Phone 
Call 
ERT 
In- 
person 
(Part 
A 
only) 
ERT 
Phone 
Call 
Tx 
2 
ERTb 
Phone 
Call 
ERTb 
Phone 
Call 
Tx 
3 
ERTb 
Phone 
Call 
ERTb 
Phone 
Call 
Tx 
4 
ERTb 
Phone 
Call 
ERTb 
Phone 
Call 
EOTc 
Follow 
-up 
Unsched- 
uledd 
Study Day 
Post-treatment 
time for each 
period 
-14 to 
1 
1 
24±6 
hours 
48±8 
hours 
7 and 
14 days 
(±24 
hours) 
1e 
24±6 
hours 
7 and 
14 days 
(±24 
hours) 
1e 
24±6 
hours 
7 and 
14 days 
(±24 
hours) 
1e 
24±6 
hours 
7 and 
14 days 
(±24 
hours) 
84 
(-0/+8 
days) 
112, 
147 
(EOS)f 
(±7 
days) 
Urine pregnancy 
testk 
X 
X 
X 
X 
X 
X 
Photographs 
(site/subject)l 
X 
X 
X 
X 
X 
X 
X 
X 
Study drug 
applicationm 
X 
X 
X 
X 
Apply surgical 
tapem 
X 
X 
X 
X 
ERT assessmentsn 
(No BA) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Prior/concomitant 
medications, 
including HPV 
immunization 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Take-home 
instructions, LSR 
guide/subject 
educationo 
X 
X 
X 
X 
Provider 
questionnaire 
X 

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VP-102 (Cantharidin) 
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Clinical Protocol 
Table 1. 
Study Schedule of Assessments and Procedures (Part A and Part B) (continued) 
Page 17 
 
 
 
 
AE = adverse event; BA = Blinded Assessor; eCRF = electronic Case Report Form; EOS = end of study; EOT=end of treatment; ERT= evaluation of response to treatment; h = hour; 
HIPAA = Health Insurance Portability and Accountability Act; ICF = Informed Consent Form; IRB = Institutional Review Board; LSR = local skin reactions; T/P = temperature, 
pulse; Tx = treatment 
 
Footnotes to Table 1 
a. 
Screening can occur up to 14 days before study drug application on Treatment Visit 1 (Day 1) or on the same day as Treatment Visit 1. If treatment is not applied on the same 
day as screening, repeat the assessments and procedures of subject eligibility, medical history, genital wart history, vital signs, wart assessments (wart count, wart measurement 
[diameter and area], location of all warts), dermatologic exam, photography (if applicable), and prior medication use at Treatment Visit 1 before study drug application. An 
IRB-approved ICF must be signed before any study specific procedures are performed. 
b. The ERT telephone calls should be conducted based on the time of study drug application. The ERT telephone calls at 24 hours (±6 hours), 7 days (±24 hours), and 14 days 
(±24 hours) after each treatment visit are not required if there was no treatment during that treatment period. The ERT telephone call at 24 hours (±6 hours), 7 days (±24 hours), 
and 14 days (±24 hours) after each treatment will only collect information since the last contact. 
c. 
All treatments may be administered over the course of up to 75 days. Provider questionnaire to be completed at the Study Day 84 (EOT) Visit by a clinician who applied 
treatment to the subject during the course of the study. 
d. In the event that any post-treatment LSR AE presents a safety concern (including but not limited to severe blistering, ulceration, edema, or pain), an “Unscheduled” clinic visit 
must be scheduled and the subject assessed accordingly. In addition, if any post-treatment AEs present a safety concern, the subject may be brought in for an unscheduled visit. 
“Unscheduled” visits should also be used for visits in which treatment is unable to be applied to all warts due to ongoing LSRs. 
e. 
Subjects are to be scheduled in 21 (±4)-day intervals after each treatment. The next treatment visit is to be scheduled 21 (±4) days after the last treatment, but only after any LSR 
has resolved sufficiently to allow evaluation of the treatment site. The research team should be in contact with the patient until LSRs are resolved and a treatment visit can be 
scheduled within 21 days (±4) when possible. 
f. 
Subjects will return for additional Follow-up Visits on Study Day 112 (±7 days) and Study Day 147 (±7 days) (EOS) for an assessment of warts to determine the durability of 
previous responses and/or LSRs. Subjects are to attend all planned in-person visits, whether they have achieved complete clearance before or at the Study Day 84 (–0/+8 days) 
EOT assessment. 
g. Demographics: date of birth, sex, race, and ethnicity will be collected. 
h. Vital signs (e.g., temperature, heart rate) will be obtained at each treatment visit before application of study drug. 
i. 
Additional limited physical examination, symptom, or AE-directed physical examination may be performed if warranted (see Source/eCRF for a more detailed description) 
j. 
Dermatologic exam (including Fitzpatrick Skin Type at Screening only) and location of each wart is specified by anatomical location. Wart count, location, and measurements 
(diameter) should be recorded at Treatment Visit 1, before treatment, to confirm that the subject meets inclusion criteria of ≥ 2 to ≤ 30 warts and that the warts are ≤ 8 mm in 
diameter each with a total wart area (i.e., all warts combined) ≥ 10 mm2. Wart area should be calculated at Screening/Treatment 1, End of Treatment, and Follow-up Visits using 
the formula “area= πr2”, where r= radius of wart. Warts that develop in areas that are unable to be treated, (e.g., close to a mucous membrane) will not be evaluated, documented, 
or considered in the analysis. Wart counts will be conducted at Screening, Treatment 1, Treatment 2, Treatment 3, Treatment 4, End of Treatment, and Follow-up Visits by a 
trained member of the study team. Other than the screening visit and Day 1, wart counts will also be conducted by a designated Blinded Assessor. Wart counts completed at 
Treatment Visit 2, Treatment Visit 3, and Treatment Visit 4; and Follow-up Visits on Study Day 84 (–0/+8 days) (EOT); Study Day 112 (±7 days), and Study Day 147 (±7 days) 
(EOS) should be performed before the dermatologic exam and ERT assessments and will be obtained by a Blinded Assessor. The Blinded Assessor does not have to be the same 
person at each visit. Blinded assessors must be trained to the study, complete Good Clinical Practices, and be listed on the FDA FORM 1572 and the site Delegation of Authority 
Log. A separate wart count including wart measurement, wart location, and dermatologic examination are conducted by a study team member who is not considered, or has not 
acted as, the Blinded Assessor for the subject throughout the subject’s participation 

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Table 1.      Study Schedule of Assessments and Procedures (Part A and Part B) (continued) 
k. Pregnancy test is to be performed before study drug application at each treatment visit (1-4) and at Follow-up Visits on Study Day 84 (–0/+8 days) (EOT), Study Day 112 
(±7 days), and Study Day 147 (±7 days) (EOS) in any females of childbearing potential (i.e., females who are capable of menstruating). 
l. 
Subjects who agree to participate in the photographic portion of the study will have photographs of warts taken before each treatment by the study team. If there are no warts 
remaining, the same areas will be photographed and repeated at the Follow-up Visits on Study Day 84 (–0/+8 days) (EOT) and Study Day 147 (±7 days) (EOS) regardless of 
whether warts are present. These images may be used on handouts in future trials, for training purposes, or future marketing materials. Photographs will be de-identified to those 
outside the research team and stored in a HIPAA compliant manner. Efforts will be made to ensure that no photographs with identifiable features are obtained. 
m. Application of study drug and surgical tape must be conducted by a study team member who is not considered, or has not acted as, the Blinded Assessor for the subject throughout 
the subject’s participation. Surgical tape should only be removed at the designated removal time, when the treatment site is washed and study drug removed. Surgical tape and 
study drug may be gently removed from individual warts before the designated removal time in the event of significant blistering, significant pain, or treatment-emergent AEs. 
The surgical tape and study drug should not be removed from the remaining unproblematic warts until the designated removal time is reached. Removal of the surgical tape 
should be aided by soap and water, which will also help to prevent unroofing the blisters. Subjects who remove study drug before the assigned time frame will be considered a 
protocol deviation unless early removal is due to protocol defined criteria. Early removal is defined as removal of study drug outside of the following windows: ±1-hour window 
for the 2-hour duration of skin exposure group; ±2-hour window for the 6-hour duration of skin exposure group, and ±6-hour window for the 24-hour duration of skin exposure 
group. 
n. In both Part A and Part B, an in-person follow-up ERT assessment will be conducted at each treatment visit (1-4) before study drug application and at Follow-up Visits on Study 
Day 84 (–0/+8 days) (EOT), Study Day 112 (±7 days), and Study Day 147 (±7 days) (EOS). In addition, for Part A Treatment Period 1 only, an in-person follow-up ERT 
assessment will be conducted at 48 hours (±8 hours). Follow-up telephone assessments for ERT will be conducted at 24 hours (±6 hours), 7 days (±24 hours), and 14 days 
(±24 hours) after each treatment visit (1-4) in which study drug is applied. Assessments will be recorded by the research team member on the ERT form. All ERT safety 
assessments must be conducted by a qualified member of the research team. ERT assessments and telephone calls must be conducted by a study team member who is not 
considered, or has not acted as, the Blinded Assessor for the subject throughout the subject’s participation. 
o. Subjects will be provided with take-home instructions describing how to remove the surgical tape, the possible LSR’s, and what to expect over the next 24 hours to several 
months. A 24-hour emergency number will also be provided. The next visit date/calls and time will be indicated on the form. An LSR Guide for subjects will be reviewed at the 
clinic with the subject by the research team, with copies provided for home use in the required post-treatment ERT follow-up telephone calls. Both take home instructions and 
LSR Guide will be provided and reviewed after each treatment to ensure understanding and confirm the education materials are available. 

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Clinical Protocol 
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2.0 
TABLE OF CONTENTS 
 
Page 
PROTOCOL APPROVAL ............................................................................................................................................ 2 
1.0 
PROTOCOL SYNOPSIS ...................................................................................................................... 4 
2.0 
TABLE OF CONTENTS ..................................................................................................................... 19 
2.1 
List of In-Text Tables ............................................................................................................................. 23 
2.2 
List of In-Text Figures ........................................................................................................................... 23 
3.0 
LIST OF ACRONYMS, ABBREVIATIONS, AND DEFINITIONS OF TERMS ......................... 24 
4.0 
BACKGROUND AND RATIONALE ................................................................................................ 25 
4.1 
Introduction ............................................................................................................................................ 25 
4.1.1 
Genital Warts ........................................................................................................................ 25 
4.1.2 
Approved Treatments ............................................................................................................ 25 
4.1.3 
Cantharidin ............................................................................................................................ 26 
4.1.4 
VP-102 .................................................................................................................................. 27 
4.2 
Nonclinical Studies ................................................................................................................................ 27 
4.3 
Clinical Experience ................................................................................................................................ 31 
4.3.1 
Study VP-102-103: Phase 2 Study Evaluating Safety, Efficacy and Systemic Exposure 
after VP-102 Treatment in Subjects with Childhood Molluscum ........................................ 34 
4.3.2 
Study 16-10-195: VP-102 Bridging Study of Subjects with Childhood Molluscum ............ 35 
4.3.3 
Cantharidin Study in Subjects with Genital Warts ................................................................ 36 
4.4 
Summary of Known Benefits and Potential Risks ................................................................................. 36 
4.4.1 
Potential Benefits .................................................................................................................. 36 
4.4.2 
Known Risks ......................................................................................................................... 37 
4.4.3 
Potential Risks ...................................................................................................................... 37 
4.4.4 
Risk-Benefit Summary .......................................................................................................... 37 
4.5 
Justification for Dosing Regimen ........................................................................................................... 38 
4.6 
Population to be Studied ........................................................................................................................ 39 
4.7 
Statement of Compliance ....................................................................................................................... 39 
5.0 
STUDY PURPOSE AND OBJECTIVES ........................................................................................... 40 
6.0 
STUDY DESIGN .................................................................................................................................. 42 
6.1 
Description of the Study ......................................................................................................................... 42 
6.1.1 
Part A (dose regimen finding) Study Design ........................................................................ 42 
6.1.2 
Part B (safety and efficacy) Study Design ............................................................................ 43 
6.1.3 
Part A and Part B Procedures ................................................................................................ 44 
6.2 
Number of Subjects ................................................................................................................................ 48 
6.3 
Measures Taken to Minimize Bias ......................................................................................................... 48 
6.4 
Expected Duration of Subject Participation ........................................................................................... 48 
6.5 
Method of Treatment Assignment and Blinding .................................................................................... 49 
7.0 
SELECTION, DISCONTINUATION, AND WITHDRAWAL OF SUBJECTS ............................ 50 
7.1 
Subject Inclusion Criteria ....................................................................................................................... 50 

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TABLE OF CONTENTS (continued) 
Page 
7.2 
Subject Exclusion Criteria ...................................................................................................................... 51 
7.3 
Requalification for Entry ........................................................................................................................ 53 
7.4 
Subject Withdrawal Criteria ................................................................................................................... 53 
7.4.1 
Adverse Event ....................................................................................................................... 54 
7.4.2 
Intercurrent Illness ................................................................................................................ 54 
7.4.3 
Noncompliance ..................................................................................................................... 54 
7.4.4 
Refusal of Investigational Product Administration ............................................................... 54 
7.4.5 
Withdrawal of Consent ......................................................................................................... 54 
7.5 
Replacement of Subjects ........................................................................................................................ 55 
7.6 
Premature Study or Site Termination ..................................................................................................... 55 
8.0 
STUDY DRUGS ................................................................................................................................... 56 
8.1 
Investigational Agent and Placebo ......................................................................................................... 56 
8.2 
Directions for Use .................................................................................................................................. 56 
8.2.1 
Application of Study Drug and Surgical Tape ...................................................................... 56 
8.2.2 
Removal of Surgical Tape and Study Drug ........................................................................... 57 
8.3 
Study Drug Storage ................................................................................................................................ 58 
8.4 
Study Drug Labeling .............................................................................................................................. 59 
8.5 
Compliance ............................................................................................................................................ 63 
8.6 
Breaking the Blind ................................................................................................................................. 63 
8.7 
Previous and Concomitant Medications ................................................................................................. 63 
8.8 
Accountability Procedures ..................................................................................................................... 64 
8.9 
Study Drug Handling and Disposal ........................................................................................................ 64 
9.0 
SUBJECT PROCEDURES ................................................................................................................. 65 
9.1 
Subject Restrictions ................................................................................................................................ 65 
9.2 
Screening Period (up to 14 days before first treatment) ......................................................................... 65 
9.3 
Treatment Period .................................................................................................................................... 66 
9.3.1 
Treatment Period 1 ................................................................................................................ 66 
9.3.2 
Treatment Periods 2, 3, 4 ...................................................................................................... 69 
9.4 
End-of-Treatment Visit: Study Day 84 (–0/+8 days) ............................................................................. 72 
9.5 
Follow-up Visits on Study Day 112 (±7 days) and Study Day 147 (±7 days) (End-of-Study) .............. 74 
9.6 
Unscheduled Visit .................................................................................................................................. 76 
9.7 
Measurements and Evaluations .............................................................................................................. 77 
9.7.1 
Skin Assessments .................................................................................................................. 77 
9.7.2 
Identification of Skin Reactions ............................................................................................ 78 
9.7.3 
Removal of Surgical tape ...................................................................................................... 78 
9.7.4 
Evaluation of Response to Treatment Assessments .............................................................. 78 
9.7.5 
Photographs of Lesions ......................................................................................................... 79 
TABLE OF CONTENTS (continued) 

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Page 
10.0 
ASSESSMENT OF SAFETY .............................................................................................................. 80 
10.1 
Safety Parameters ................................................................................................................................... 80 
10.2 
Definitions .............................................................................................................................................. 80 
10.2.1 
Adverse Event ....................................................................................................................... 80 
10.2.2 
Serious Adverse Event .......................................................................................................... 82 
10.2.3 
Expectedness of Serious Adverse Events .............................................................................. 84 
10.3 
Assessment of Intensity .......................................................................................................................... 84 
10.4 
Assessment of Causality ......................................................................................................................... 85 
10.5 
Recording Adverse Events and Serious Adverse Events ....................................................................... 86 
10.6 
Reporting of Serious Adverse Events .................................................................................................... 86 
10.7 
Follow-up of Adverse Events and Serious Adverse Events ................................................................... 87 
10.8 
Risks for Women of Child-bearing Potential or During Pregnancy ....................................................... 88 
10.9 
Special Safety Considerations ................................................................................................................ 88 
11.0 
ASSESSMENT OF EFFICACY ......................................................................................................... 90 
11.1 
Efficacy Parameters ................................................................................................................................ 90 
12.0 
STATISTICAL METHODS ................................................................................................................ 92 
12.1 
Analysis Populations .............................................................................................................................. 92 
12.2 
Analysis of Study Population and Subject Characteristics ..................................................................... 92 
12.3 
Efficacy Analyses ................................................................................................................................... 93 
12.4 
Safety Analyses ...................................................................................................................................... 93 
12.5 
Interim Analysis ..................................................................................................................................... 94 
12.6 
Determination of Study Sample Size...................................................................................................... 94 
12.7 
Handling of Missing, Unused, and Spurious Data ................................................................................. 94 
12.8 
Termination Criteria ............................................................................................................................... 95 
12.9 
Deviation Reporting ............................................................................................................................... 95 
13.0 
PROTECTION OF HUMAN SUBJECTS ......................................................................................... 96 
14.0 
INVESTIGATOR REQUIREMENTS ............................................................................................... 97 
14.1 
Investigator Information ......................................................................................................................... 97 
14.2 
Investigator’s Study Files ....................................................................................................................... 97 
14.3 
Electronic Case Report Forms and Source Documentation ................................................................... 97 
14.4 
Retention of Study Documents ............................................................................................................... 97 
14.5 
Confidentiality ....................................................................................................................................... 98 
14.5.1 
Data ....................................................................................................................................... 98 
14.5.2 
Subject Anonymity ............................................................................................................... 98 
14.6 
Protocol Compliance .............................................................................................................................. 99 
TABLE OF CONTENTS (continued) 

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Page 
14.7 
Study Monitor Functions and Responsibility ......................................................................................... 99 
14.8 
General Information ............................................................................................................................... 99 
15.0 
DATA HANDLING AND RECORD KEEPING ............................................................................ 100 
16.0 
QUALITY CONTROL AND QUALITY ASSURANCE ................................................................ 101 
17.0 
FINANCING AND INSURANCE .................................................................................................... 102 
18.0 
PUBLICATION POLICY ................................................................................................................. 103 
19.0 
REFERENCES ................................................................................................................................... 104 
APPENDICES ........................................................................................................................................................... 107 

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2.1 
List of In-Text Tables 
Page                             
Table 1. 
Study Schedule of Assessments and Procedures (Part A and Part B) ........................................... 15 
Table 2. 
Summary of VP-102 Nonclinical Program ................................................................................... 29 
Table 3. 
Phase 2 and Phase 3 Clinical Studies with VP-102 ...................................................................... 32 
Table 4. 
Classification of Adverse Events by Intensity .............................................................................. 84 
Table 5. 
Assessment of Causality of AEs ................................................................................................... 85 
Table 6. 
Timeline for Reporting of Serious Adverse Events ...................................................................... 86 
 
 
2.2 
List of In-Text Figures 
 
 
 
Figure 1. 
Label on Applicator ...................................................................................................................... 61 
Figure 2. 
Label on Pouch Containing Each Applicator ................................................................................ 61 
Figure 3. 
Kit Top Label ................................................................................................................................ 62 
Figure 4. 
Kit Side Label ............................................................................................................................... 62 

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3.0 
LIST OF ACRONYMS, ABBREVIATIONS, AND DEFINITIONS OF TERMS 
 
Abbreviation 
Definition 
AE 
adverse event 
BA 
Blinded Assessor 
CDLQI 
Children’s Dermatology Life Quality Index 
CREST 
calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and 
telangiectasia 
eCRF 
electronic case report form 
EGW 
external genital warts 
EOS 
End-of-Study 
EOT 
End-of-Treatment 
EDC 
electronic data capture 
ERT 
evaluation of response to treatment 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practices 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
HEK 
human embryonic kidney 
hERG 
human ether-à-go-go-related gene 
HIPAA 
Health Insurance Portability and Accountability Act 
HPBL 
human peripheral blood lymphocytes 
HPV 
human papilloma virus 
IB 
Investigator’s Brochure 
IC50 
concentration required for 50% inhibition 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation 
IND 
Investigational New Drug (application) 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
ITT 
Intent-to-Treat (population) 
IV 
intravenous 
LSR 
local skin reaction 
MC, molluscum 
molluscum contagiosum 
MedDRA 
Medical Dictionary for Regulatory Activities 
MN 
micronucleus 
N, n 
number 
PP 
Per-Protocol (population) 
QoL 
quality of life 
SAE 
serious adverse event 
SOP 
standard operating procedure 
TCA 
trichloroacetic acid 
TEAE 
treatment-emergent adverse event 
T/P 
temperature, pulse 
Tx 
treatment 
VP-102 
Verrica Pharmaceuticals-102 (0.7% w/v cantharidin) 
w/v 
weight/volume 

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4.0 
BACKGROUND AND RATIONALE 
 
4.1 
Introduction 
 
4.1.1 
Genital Warts 
 
Genital warts (also known as anogenital warts or condyloma acuminatum) is a sexually 
transmitted viral disease caused by multiple different types of the human papilloma 
virus (HPV).[1] Human papilloma virus is spread through direct skin-to-skin contact, 
usually during oral, genital, or anal sex with an infected partner.[2] Human papilloma 
virus affects the epidermis, vulva, vagina, cervix, and rectum. Diagnosis of genital 
warts is usually made by visual inspection and can be confirmed by biopsy.[3] The four 
morphologic types of genital warts are cauliflower-shaped, smooth papular, keratotic, 
and flat. Genital warts cause few symptoms but can occasionally be painful. Conditions 
known to predispose women to infection with HPV include local trauma, diabetes, and 
immuno-suppression.[1] 
 
Human papillomavirus (HPV) is the most common sexually transmitted infection in 
the United States.[4] Approximately 1% of people in the United States have genital 
warts.[5] Risk factors for genital warts include multiple sex partners, early onset of 
sexual activity, long-term oral contraceptive use in women and previous history of 
other sexually transmitted diseases (e.g., chlamydia, gonorrhea, genital herpes or 
trichomoniasis, human immunodeficiency virus, herpes).[6] 
 
Safe and effective HPV vaccines are available for adolescents and young adults, but do 
not protect against all HPV types that can cause genital warts[5] Abstinence is the only 
completely effective way of avoiding genital warts. 
 
4.1.2 
Approved Treatments 
 
The goal of treatment is to eliminate lesions. Most treatments for warts focus on 
destruction of the lesion through electrocautery, chemical burning, cryotherapy, or 
immune mediators.[1] Currently available treatments for genital warts include 
podophyllin, imiquimod, sinecatechins, and procedural therapies such as cryotherapy, 
trichloroacetic acid (TCA), laser, surgical, and electrocautery). A recently published 
clinical study explored the efficacy of topical compounded cantharidin compared to 
TCA (Section 4.4.3).[1] No single treatment is ideal for all patients and all warts. 

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Treatment of anogenital warts is guided by wart size, number, anatomic site, patient 
preference; convenience; and provider experience. In addition, each of these treatments 
have shortcomings related to multiple applications, erosions and erythema, adverse 
effects, long times for resolution, and expense.[1] Because of these shortcomings, some 
clinicians have employed combination therapy (e.g., provider-administered 
cryotherapy with patient-applied topical therapy between visits to the provider).[3] 
However, limited data has been published on the safety and efficacy of combination 
therapies.[3] 
 
4.1.3 
Cantharidin 
 
For many dermatologists, 0.7% w/v cantharidin has been the treatment of choice for 
common warts and molluscum contagiosum (MC) for decades.[7]. However, 
cantharidin remains an unapproved drug and there is no reliable or controlled source 
on the market. 
 
Cantharidin (1,2-dimethyl-3,6-epoxyperhydrophthalic anhydride) is a lipophilic 
natural compound that can be isolated from the body fluids of the blister beetle, 
primarily of the family Meloidae. The Mylabris species of beetle contains a much 
greater concentration of cantharidin than other species and is the primary type of beetle 
used in modern cantharidin preparations. 
 
In contrast to currently available therapies, cantharidin functions as a vesicant, 
weakening desmosomes in the epidermis when applied topically via a liquid film- 
forming formulation. Application to the skin causes the activation of neutral serine 
proteases resulting in the destruction of intercellular desmosomes responsible for 
holding the layers of the skin together.[8] Intracellular tonofilaments are also weakened, 
the result being a fluid-filled, thin-walled, epidermal vesicle. The superficial nature of 
the blisters is attributed to cantharidin’s lesser effect on hemidesmosomes in the basal 
layer compared to the more superficial desmosomes. This process is not associated with 
scarring, as the underlying dermal layer of skin is undamaged. Cantharidin has no 
known direct antiviral effects. Cantharidin application also can stimulate an immune 
response in the skin that can cause local inflammation, which may be a contributing 
factor in treating viral skin disease.[9] 

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4.1.4 
VP-102 
 
VP-102, a 0.7% w/v topical film-forming cantharidin formulation has been developed 
to be consistent with the predominant concentration of cantharidin used by physicians. 
VP-102 is administered with a single-use applicator to minimize cross-contamination 
and concentration changes during use. Each VP-102 applicator contains 0.45 mL of 
drug product. Gentian violet, a dye common in surgical markers, has also been included 
to facilitate physician recognition of treated versus untreated lesions. Finally, to afford 
additional safety and deter potential oral ingestion of the drug, the oral deterrent 
denatonium benzoate has been included. 
 
4.2 
Nonclinical Studies 
 
Cantharidin is a potent inhibitor of protein phosphatases that are found in all tissues.[10] 
The inhibition of these phosphatases may be involved in cantharidin’s systemic 
manifestations when delivered orally or via injection (Section 6.1.1 of the 
Investigator’s Brochure [IB]). The available nonclinical studies to assess the potential 
for untoward pharmacodynamic effects of cantharidin with systemic exposure have 
largely focused on the cardiovascular system. With acute systemic exposure of rats to 
oral dosing with 6.9 mg/kg (41.4 mg/m2) of cantharidin, cardiac waveform and function 
were adversely affected, likely related to its inhibitory effect on protein 
phosphatases.[11]. Cantharidin is a vasoconstrictor and may also be responsible for 
decreases in urine volume with single oral dose administration.[11, 12] However, it is 
possible that cantharidin may have a direct effect on the renal vascular and tubular 
epithelium via its inhibitory action on protein phosphatases. Cantharidin may also have 
an effect on central nervous system function,[11] although it is unclear whether noted 
decreases in locomotion and reduced body temperature were secondary to the 
cardiovascular manifestations noted with the high doses. 
 
Information available on the pharmacokinetics and metabolism of cantharidin showed 
that oral absorption of cantharidin in rats and dogs is rapid but incomplete, with peak 
systemic exposures occurring by 2 hours in rats (Section 6.2 of the IB).[13] The apparent 
plasma elimination half-life of cantharidin was about 20 minutes in dogs.[14] Tissue 
distribution of cantharidin was ubiquitous, consistent with the widespread distribution 
of protein phosphatases. 

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Nonclinical toxicity information available on cantharidin is predominantly from single 
dose (acute) studies by the dermal, oral, intraperitoneal, and intravenous (IV) routes of 
administration (Section 6.3 of the IB). The only adverse findings associated with acute 
dermal exposure to cantharidin in animals were local irritation and skin blistering. No 
systemic toxicity was noted by this route in animals. 
 
With an extensive history of use of cantharidin in humans, a limited nonclinical 
program has been developed to support the use of topical (dermal) VP-102. No 
nonclinical primary pharmacodynamic or pharmacokinetic studies were conducted by 
Verrica using either VP-102 or cantharidin. A single Good Laboratory Practices (GLP)- 
compliant study evaluating inhibition of the human ether-à-go-go-related gene (hERG) 
channel as an in vitro cardiovascular safety pharmacology endpoint was conducted. 
 
The safety profile of topical cantharidin is already well established from its history of 
use in patients, as well as studies conducted in animals. With negligible systemic 
exposure after topical application, the strategy for the nonclinical toxicology program 
for VP-102 developed by Verrica focused on addressing the pending concerns 
associated with its use as a topical treatment; thus, Verrica completed the GLP in vitro 
genetic toxicity testing battery with cantharidin, including a bacterial reverse mutation 
assay, a mammalian cell chromosomal aberration assay, and a mammalian cell 
micronucleus assay. 
 
An overview of the Verrica-sponsored toxicology studies conducted with cantharidin 
is provided in Table 2. 

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Table 2.          Summary of VP-102 Nonclinical Program 
Type of 
Study 
Category 
Test 
Article 
Route 
Test System 
Key Finding(s) 
Pharmacology 
Safety 
pharmacology: 
cardiovascular 
(hERG assay) 
Cantharidin 
In 
vitro 
hERG-transfected 
HEK293 cells 
Mean ± SEM inhibition of 
hERG current was 1.9 ±0.3% 
(n = 3) for 30 µM, cantharidin 
and 3.5 ±0.4% for 300 µM 
cantharidin; neither statistically 
significant compared with 
vehicle control (2.1 ±0.4%). IC50 
of cantharidin on hERG current 
> 300 µM 
Toxicology 
Genetic 
toxicity: 
bacterial 
reverse 
mutation assay 
Cantharidin 
In 
vitro 
Salmonella 
typhimurium tester 
strains TA98, 
TA100, TA1535, 
and TA1537 and 
Escherichia coli 
tester strain WP2 
uvrA 
Cantharidin negative at all 
concentrations tested (15.0-5000 
µg/plate) in all strains tested in 
presence or absence of S9 
activation. Cantharidin does not 
possess mutagenic properties 
Genetic 
toxicity: 
mammalian 
cell 
chromosomal 
aberration 
assay 
Cantharidin 
In 
vitro 
HPBL 
Study inconclusive and 
terminated before completion 
due to overly condensed 
metaphase chromosomes at 
several concentrations, which 
did not allow for adequate 
evaluation of test samples that 
would meet criteria for a valid 
assay in accordance with ICH 
S2(R1) guidance 
Genetic 
toxicity: 
mammalian 
cell 
micronucleus 
assay 
Cantharidin 
In 
vitro 
TK6 human 
lymphoblastoid 
cells 
Cantharidin at ≥ 1 µg/mL 
induced formation of MN with 
27-hour exposure, but increase 
in MN not observed at similar 
concentrations with 4-hour 
exposure. Subsequent CREST 
staining revealed MN formed 
via aneugenic, not clastogenic, 
mechanism of action 
CREST = calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia; HEK = 
human embryonic kidney; hERG = human ether-à-go-go-related gene; HPBL = human peripheral blood lymphocytes; 
IC50 = concentration required for 50% inhibition; ICH = International Conference on Harmonisation; MN = 
micronucleus 

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Verrica completed one in vitro GLP safety pharmacology study that evaluated the 
concentration response relationship of the effect of cantharidin on the hERG potassium 
channel current in stably transfected mammalian cells that express the hERG gene 
(Study 170922.WFU). Specifically, the study examined the inhibitory effects of 
cantharidin on the hERG channel current at near-physiologic temperature. The study 
reported no change in hERG current across the cantharidin concentration range (30 and 
300 µM). The IC50 for the inhibitory effect of cantharidin on hERG potassium current 
was estimated to be > 300 μM (> 60,000 ng/mL). At 300 μM, the concentration of 
cantharidin is > 17,000-fold higher than the highest level of cantharidin detected 
systemically (3.4 ng/mL) in a clinical exposure study conducted with topical 
administration of VP-102 in molluscum patients (Study VP-102-103). 
 
Verrica completed a GLP-compliant in vitro genetic toxicity test battery with 
cantharidin. Three in vitro genotoxicity studies were conducted: a bacterial reverse 
mutation assay (Ames test), a mammalian cell micronucleus assay in TK6 human 
lymphoblastoid cells, and a mammalian cell chromosomal aberration assay in human 
peripheral blood lymphocytes (HPBL). 
 
For the bacterial reverse mutation assay (Study AE58BG.502ICH.BTL), cantharidin 
was evaluated for its mutagenic potential by measuring its ability to induce reverse 
mutations at selected loci of Salmonella typhimurium TA98, TA100, TA1535, and 
TA1537, and at the tryptophan locus of Escherichia coliWP2 uvrA in the presence and 
absence of an exogenous metabolic activation system. Based on the results of the 
preliminary toxicity assay, the maximum dose to be tested in the mutagenicity assay 
was 5000 µg/plate. At all concentrations tested, cantharidin was negative at select loci 
of several S. typhimurum and E. coli tester strains, suggesting that cantharidin does not 
possess mutagenic properties. 
 
In the mammalian cell chromosomal aberration assay, cantharidin was evaluated for its 
potential to induce structural chromosomal aberrations using HPBL in either the 
presence or the absence of an exogenous metabolic activation system (Study 
AE58BG.341ICH.BTL). Overly condensed and distorted metaphase chromosomes 
were noted during the assay at several concentrations with < 50% cytotoxicity, which 
did not allow for an adequate evaluation of the test samples that would meet the criteria 
for a valid assay in accordance with ICH S2(R1) guidance, and thus the study was 
terminated before completion. 

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The mammalian cell genotoxicity study assessed the clastogenic potential of 
cantharidin (Study AE58BG.361CRESTICH.BTL). Specifically, cantharidin was 
evaluated for its potential to induce micronuclei in TK6 human lymphoblastoid cells in 
either the presence or absence of an exogenous metabolic activation system. A dose- 
dependent increase in micronuclei formation was observed in the non-activated 27- 
hour treatment group with cantharidin doses of 1 µg/mL (1.25%) to 1.6 µg/mL (2.25%) 
compared with vehicle (0.65%). An increase in micronuclei formation was not 
observed at similar concentrations with a 4-hour exposure. Compared with the vehicle 
group, an increase in micronucleus induction in either the absence or presence of an 
exogenous metabolic activation system was observed at higher cantharidin 
concentrations of 3.5 µg/mL (1.40% vs 0.55%, respectively) and 5.5 µg/mL (1.20% vs 
0.60%, respectively) in the 4-hour treatment groups. Subsequent analysis with 
calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and 
telangiectasia (CREST) staining revealed that a high frequency of micronuclei in the 
presence of kinetochore staining was observed in the cantharidin-treated cells, 
suggesting that cantharidin induces micronuclei formation through an aneugenic, and 
not a clastogenic, mechanism of action. 
 
4.3 
Clinical Experience 
 
A summary of VP-102 Phase 2 and Phase 3 clinical studies in subjects with molluscum 
contagiosum are presented in Table 3. A phase 2 study (VP-102-105) evaluating the 
safety and efficacy of VP-102 in subjects with common warts is ongoing. No clinical 
studies have been conducted to date with VP-102 in subjects with external genital 
warts. 
 
In addition to the summary information in Table 3, additional results are provided for 
two of the VP-102 studies: 
 
1. Results from Phase 2 study VP-102-103 are presented in Section 4.3.1 because this 
study provides relevant information on the systemic exposure in subjects with 
molluscum after treatment with VP-102 
 
2. Results from Phase 2 study 16-10-195 are presented in Section 4.3.2 because this 
study treated subjects with molluscum for 6 hours and 24 hours 
 
Results from a study of cantharidin in subjects with genital warts are presented in 
Section 4.3.3. 

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Table 3. 
Phase 2 and Phase 3 Clinical Studies with VP-102 
Study 
Study Design 
Objectives 
Number of Subjects 
Drug/Device and Dosing 
Regimen 
Results 
VP-102 
-101 
(CAMP-1) 
Pivotal Phase 
3, 
randomized, 
double-blind, 
placebo- 
controlled 
Primary: To evaluate efficacy (proportion subjects 
achieving complete clearance of all treatable lesions) of 
VP-102 relative to placebo at Day 84 
Secondary: 
• To assess safety and tolerability (AEs, LSRs, physical 
examinations, and concomitant medications) of 
VP-102 compared to baseline at Day 84 
• To assess efficacy (proportion of subjects achieving 
complete clearance of all treatable lesions) of VP-102 
relative to placebo at Visit 2, Visit 3, and Visit 4 
N=266 subjects with 
molluscum contagiosum 
lesions 
n=161 VP-102 
n=105 placebo 
(3:2 VP-102: placebo 
randomization) 
VP-102 solution and 
applicator 
Single 24-hour treatment 
every 21 days for up to 4 
applications 
Statistically significant primary 
efficacy endpoint met (p<.0001) 
Secondary efficacy endpoints 
met at Visits 2, 3, and 4 
Confirmed safety and efficacy 
with VP-102 in applicator 
VP-102 
-102 
(CAMP-2) 
Pivotal Phase 
3, 
randomized, 
double-blind, 
placebo- 
controlled 
Primary: To evaluate efficacy (proportion subjects 
achieving complete clearance of all treatable lesions) of 
VP-102 relative to placebo at Day 84 
Secondary: 
• To assess safety and tolerability (AEs, LSRs, physical 
examinations, and concomitant medications) of 
VP-102 compared to baseline at Day 84 
• To assess efficacy (proportion of subjects achieving 
complete clearance of all treatable lesions) of VP-102 
relative to placebo at Visit 2, Visit 3, and Visit 4 
N=262 subjects with 
molluscum contagiosum 
lesions 
n=150 VP-102 
n=112 placebo 
(3:2 VP-102: placebo 
randomization) 
VP-102 solution and 
applicator 
Single 24-hour treatment 
every 21 days for up to 4 
applications 
Statistically significant primary 
efficacy endpoint met (p<.0001) 
Secondary efficacy endpoints 
met at Visits 3 and 4 
Confirmed safety and efficacy 
with VP-102 in applicator 
VP-102 
-103 
Phase 2 open- 
label 
Primary: To determine presence or absence of systemic 
cantharidin exposure from single 24-hour dermal 
application of VP-102 applied to molluscum lesions. 
Secondary: 
• To assess safety (AEs, LSRs, physical examinations, 
concomitant medications) of VP-102 
• To assess efficacy (clearance or reduction of treated 
lesions compared to baseline) of VP-102. 
• To assess impact of VP-102 treatment on QoL 
(assessed via CDLQI) 
N=33 subjects (all 
exposed to VP-102) with 
molluscum contagiosum 
lesions 
VP-102 solution and 
applicator 
Single 24-hour treatment 
every 21 days for up to 4 
applications 
Negligible systemic exposure 
under maximal use conditions. 
Confirmed safety and efficacy 
with VP-102 in applicator. 

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Table 3. 
Phase 2 and Phase 3 Clinical Studies with VP-102 (continued) 
Study 
Study Design 
Objectives 
Number of Subjects 
Drug/Device and Dosing 
Regimen 
Results 
Study 12- 
01-004 
Phase 2 
Safety and efficacy 
N=94 subjects with 
molluscum contagiosum 
Compounded topical 
cantharidin (0.7% w/v) 
applied with wooden 
stick 
6-hour treatment every 
21 days 
Cantharidin was well tolerated 
and associated with the 
clearance of molluscum 
contagiosum. 
Study 16- 
10-195 
Phase 2 
Safety and efficacy 
N=30 subjects with 
molluscum contagiosum 
(all exposed to VP-102) 
Cohort 1: n = 14 
Cohort 2: n =16 
Topical VP-102 solution 
with wooden stick 
Cohort 1: 6-hour 
treatment every 21 days 
Cohort 2: 24-hour 
treatment every 21 days 
VP-102 was well tolerated with 
similar efficacy compared to 
cantharidin 
6-hour and 24-hour application 
demonstrated similar 
tolerability and efficacy 
AE = adverse event; CDLQI = Children’s Dermatology Life Quality Index; LSR = local skin reactions; N= number; QoL = quality of life 

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4.3.1 
Study VP-102-103: Phase 2 Study Evaluating Safety, Efficacy and Systemic 
Exposure after VP-102 Treatment in Subjects with Childhood Molluscum 
 
VP-102 in the proprietary applicator was determined to be safe in a 12-week, open-
label, Phase 2 study (VP-102-103) implemented under Investigation New Drug (IND) 
application 131163/NCT03186378. The primary objective of the study was to 
evaluate the potential systemic exposure to cantharidin under maximum use conditions 
(> 21 lesions treated). Subjects ≥ 2 years of age with molluscum contagiosum were 
enrolled and treated with VP-102 (a single-use proprietary applicator containing a 
novel 0.7% w/v cantharidin solution) every 21 days for up to 4 treatments or until 
complete lesion clearance. Subjects were instructed to wash VP-102 off at 24 hours, or 
earlier if significant pain or blistering. Lesion counts and adverse events (AEs), 
including local skin reactions (LSRs), were documented at each visit. Quality of life 
(QoL) was measured using the Children’s Dermatology Life Quality Index (CDLQI). 
A subset of 17 subjects with ≥ 21 MC lesions at baseline were evaluated for systemic 
exposure with 4 blood samples (pre-dose and at 2, 6, and 24 hours post-dose). Key 
efficacy endpoints were percentage of subjects exhibiting complete clearance of all 
treated MC lesions (baseline and new) on or before Week 12 and percentage of 
reduction of treated MC lesions from baseline at Week 12. 
 
The mean age was 6.7 (range 2-15) years for the 33 subjects enrolled. The majority of 
subjects were male (54.5%), white (90.9%), and not Hispanic/Latino (93.9%), with a 
mean time since diagnosis of 36 days and no previous treatment for molluscum 
(60.6%). 
 
Treatment with VP-102 was well-tolerated. A total of 29 subjects (88%) reported at 
least one treatment-emergent adverse event (TEAE), including expected LSRs such as 
blistering or erythema. Most subjects had mild TEAEs; 3 subjects had moderate 
TEAEs. Overall, 21 (63.6%) subjects had TEAEs related to study drug, most of which 
were LSRs. There were no serious adverse events (SAEs) or TEAEs leading to 
premature study withdrawal. 
 
Treatment with VP-102 was associated with significantly reduced lesion count, 
improved QoL, and complete clearance of MC lesions. Sixteen (16) subjects (48.5%) 
achieved complete clearance of all MC lesions on or before Week 12. The median 
lesion count was reduced 98% from baseline to Week 12. Decreases in mean CDLQI 
composite scores were observed, from 2.58 (standard deviation = 3.446) at baseline to 

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0.38 (standard deviation =0.871) at Week 12. No subjects reported spread of 
molluscum lesions to any siblings during the study. 
 
Plasma drug levels were below the limit of quantitation in 65 of 66 samples. In one 
subject, the level was slightly above the lower limit of quantitation 2 hours after VP-102 
application but was not detectable at 6 and 24 hours. Importantly, no systemic 
cantharidin was detected in the patient with the highest number of lesions (113 lesions 
treated) nor in the two subjects with genital involvement. 
 
In a separate double-blind, Phase 2 study (12-01-004), topical cantharidin (0.7% w/v) 
was well tolerated and associated with the clearance of MC in 94 subjects with 
childhood molluscum.[15] 
 
4.3.2 
Study 16-10-195: VP-102 Bridging Study of Subjects with Childhood Molluscum 
 
A bridging study (16-10-195), conducted under IND #114032, was implemented to 
confirm VP-102’s similarity in safety and efficacy to a 0.7% compounded cantharidin 
formulation used previously under the same IND. For this study, VP-102 was packaged 
in single-use, screw-top vials and applied with the wooden part of a cotton-tipped swab 
to two cohorts of subjects. The first cohort investigated a 6-hour treatment duration. A 
second cohort investigated a 24-hour treatment duration. 
 
In total, 30 subjects were enrolled with childhood molluscum, 14 subjects in the 6-hour 
cohort and 16 subjects in the 24-hour cohort. 
 
VP-102 was safe and well tolerated in the treatment of pediatric molluscum with both 
a 6-hour and 24-hour duration of exposure on the skin, consistent with historically used 
cantharidin formulations. There were no unexpected treatment-related AEs reported 
during application to molluscum lesions in 14 subjects in the 6-hour exposure cohort. 
Moreover, there were no treatment-related AEs reported with application to 712 lesions 
in 16 subjects in the 24-hour exposure cohort. 
 
Overall, 11 out of 25 (44%) subjects showed complete clearance in the Per-Protocol 
(PP) Population. The 6-hour and 24-hour application demonstrated similar tolerability 
and efficacy in this study. VP-102 was similarly effective compared to compounded 
cantharidin, as evaluated in Study 12-01-004. 

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4.3.3 
Cantharidin Study in Subjects with Genital Warts 
 
One study of cantharidin for the treatment of genital warts has been published. A 
randomized, controlled trial of cantharidin was conducted in 12 patients with non-
mucosal genital warts.[1] Patients were randomized to either compounded cantharidin 
(n=6 patients with 15 warts) or TCA (n=6 patients with 14 warts) treatment. Cantharidin 
was applied to the skin and allowed to dry, covered with a transparent adhesive 
waterproof film dressing, and after 4 to 6 hours, the treatment area was washed with 
soap and water to control skin exposure. Cantharidin was more effective and better 
tolerated than TCA for the treatment of lesions. Complete clearance of warts occurred 
in 100% of patients treated with cantharidin and 66% of patients treated with TCA 
(P=0.45). Patients treated with cantharidin, compared to TCA, healed with less 
scarring (P<0.034), had less pain during treatment (P<0.01), and required fewer 
treatments to eradicate warts (P<0.01). 
 
4.4 
Summary of Known Benefits and Potential Risks 
 
4.4.1 
Potential Benefits 
 
No studies with VP-102 have been conducted in subjects with genital warts and the 
potential benefit is uncertain. It is anticipated that subjects participating in this study 
who are randomized to the VP-102 group will experience at least similar therapeutic 
benefits as subjects treated with VP-102 or 0.7% w/v cantharidin in previous clinical 
studies. Efficacy data for VP-102 and cantharidin are provided in Section 4.3 and 
described in the IB. 
 
Approximately 80% of the subjects enrolled in Part A of this study will be randomized 
to receive VP-102. Approximately 60% of the subjects enrolled in Part B of this study 
will be randomized to receive VP-102. 

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4.4.2 
Known Risks 
 
No studies with VP-102 have been conducted in subjects with genital warts, and thus 
the potential risks are uncertain. Safety and PK data for VP-102 are provided in 
Section 4.3 and described in the IB. Nonclinical data for VP-102 are presented in 
Section 4.2 and described in the IB. Although the study drug will be labeled exclusively 
for topical application and will be applied only by study personnel, the formulation also 
contains an oral deterrent (denatonium benzoate) to further help mitigate the risk of 
accidental ingestion. 
 
The mechanism of action of cantharidin, when applied externally, is that of a vesicant 
(blistering agent) and can cause severe chemical burns at high concentrations. 
Cantharidin taken internally can be poisonous to humans. Cantharidin is classified as 
an extremely hazardous substance in the United States and is subject to strict reporting 
requirements by facilities that produce, store, or use it in significant quantities.[16] 
However, cantharidin can be safely and effectively used to treat some benign skin 
lesions when formulated properly and applied in the clinic topically by a medical 
provider familiar with its effects and uses.[17] 
 
The most frequently reported AEs in clinical trials with VP-102 conducted in subjects 
with MC were application site vesicles, application site scab, application site pain, 
application site erythema, and application site pruritus. These are well-known, 
reversible reactions of the skin that are related to the mechanism of action of 
cantharidin, a vesicant. 
 
4.4.3 
Potential Risks 
 
Cantharidin is a member of the Terpenoid Class. The Terpenoid Class is a large and 
diverse class of naturally occurring organic chemicals derived from terpenes. 
 
Because there may be unknown and potential risks with administration of VP-102, all 
subjects will be closely monitored for safety and tolerability by repeated assessment of 
clinical, vital signs, and reporting of AEs. 
 
4.4.4 
Risk-Benefit Summary 
Overall, based on risk/benefit analysis, the current study appears to be fully justified in 
the planned population of subjects with genital warts. 

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4.5 
Justification for Dosing Regimen 
This study will evaluate VP-102, a controlled, highly-pure, standardized form of topical 
cantharidin manufactured under Good Manufacturing Practices (GMP) to address the 
problems associated with currently available compounded cantharidin products and the 
needs of subjects and medical professionals. 
 
A 0.7% w/v cantharidin solution is the recognized therapeutic dose of cantharidin for 
wart treatment in dermatological clinical practice.[7, 18-21] VP-102, a drug-device 
combination containing 0.7% w/v cantharidin, was determined to be safe and effective 
in two recently completed double-blind, randomized, placebo-controlled, Phase 3 
studies that enrolled > 500 subjects ≥ 2 years of age with molluscum contagiosum. The 
only published study of cantharidin for the treatment of genital warts demonstrated 
enhanced safety and efficacy with a 0.7% cantharidin solution applied for 4 to 6 hours 
with occlusion compared to TCA.[1] Additionally, multiple publications have 
demonstrated safety and efficacy with a 0.7% cantharidin solution in common warts, 
both with and without the use of surgical tape.[7, 18-24]. 
 
In this study, lesions will be covered with surgical tape, a technique often used in the 
treatment of warts with cantharidin. It is believed that this technique helps the drug 
penetrate into the hyperkeratotic tissue and may result in improved efficacy. This will 
also eliminate unintentional transference of study drug to healthy tissue. 
 
Study drug will be applied in sufficient quantity to cover the entirety of each wart, 
including approximately a 1 mm margin of surrounding, healthy skin. 
 
The duration of skin exposure to cantharidin, the active ingredient in VP-102, will be 
controlled in this study. In Part A, VP-102 will remain on the skin for up to 2 hours in 
group 1 and the exposure will be increased to 6 and 24 hours in subsequent groups 
based on the assessment of safety and tolerability. The duration of skin exposure will 
be modulated by washing of the treatment area at either the pre-determined time per 
protocol or based on clinical response (e.g., significant blistering or pain), consistent 
with current clinical practice with the use of cantharidin (directions for use are provided 
in Section 8.2).[17] The 2-hour duration of skin exposure was selected as the starting 
point based on a published clinical study with 0.7% cantharidin, which demonstrated 
favorable safety and efficacy with a 4- to 6-hour treatment duration. The 6-hour and 
24-hour time periods were selected to allow a safe and controlled step-wise increase in 

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skin exposure that would be expected to result in a meaningful increase in the 
pharmacodynamic response in the skin (e.g., blistering). 
 
The dosing regimen for Part B will be selected based on the response observed in 
subjects during the dose regimen finding performed in Part A. 
 
4.6 
Population to be Studied 
In this study, adult subjects ages 18 and older, with external genital warts (EGW), will 
be included. External genital warts are defined as warts located in the medial thigh 
(except inguinal fold); supra-pubic, perineal, and perianal areas, vulva (excluding labia 
minora and mucosal surfaces), over the glans penis (excluding urethral meatus), penis 
shaft, scrotum, and foreskin. 
 
4.7 
Statement of Compliance 
This study will be conducted in compliance with the protocol, Good Clinical Practice 
(GCP), the ethical principles of the Declaration of Helsinki, and applicable regulatory 
and Institutional Review Board (IRB) or Independent Ethics Committee (IEC) 
requirements. 

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5.0 
STUDY PURPOSE AND OBJECTIVES 
Part A (Dose Regimen Finding) 
Primary objective: 
 
• To evaluate three regimens of application of VP-102 (2-hour, 6-hour, 24-hour 
duration of skin exposure) in subjects with EGW and identify the two best regimens 
by assessing safety and tolerability of VP-102 when administered topically after all 
subjects have completed a 48-hour assessment. 
 
Primary efficacy objective: 
 
• To evaluate the efficacy of VP-102 when administered topically to EGW once 
every 21 days for up to 4 applications by assessing the proportion of subjects 
achieving complete clearance of all treatable warts (baseline and new) at the Study 
Day 84 End-of-Treatment (EOT) Visit 
 
Part B (Safety and Efficacy) 
Primary objective: 
• To evaluate two regimens of application of VP-102 in subjects with EGW and 
identify the regimen with the best risk:benefit profile when administered topically 
once every 21 days for up to 4 applications. 
 
Part A & B (Safety and Efficacy) 
Secondary objectives: 
• To assess the safety and tolerability of VP-102 in subjects with EGW by evaluating 
AEs including expected LSRs, vital signs, and concomitant medications 
 
• To evaluate the efficacy of VP-102 when administered topically to EGW once 
every 21 days for up to 4 applications by assessing the proportion of subjects 
achieving complete clearance of all treatable warts (baseline and new) at Treatment 
Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study 
Day 112 and Study Day 147 (End-of-Study [EOS]) 

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• To evaluate the efficacy of VP-102 by assessing the change from baseline in the 
number of treatable warts (baseline and new) at each scheduled postbaseline visit 
 
• To evaluate the efficacy of VP-102 by assessing the percent change from baseline 
in the number of treatable warts (baseline and new) at each scheduled postbaseline 
visit 
 
• To evaluate the efficacy of VP-102 by assessing the proportion of subjects 
exhibiting 75% and 90% clearance of all treatable warts (baseline and new) at each 
scheduled postbaseline visit 
 
Exploratory objectives 
 
• To evaluate the efficacy of VP-102 by assessing the proportion of subjects 
exhibiting reduction of ≥1 treatable wart from baseline at each scheduled 
postbaseline visit 
 
• To evaluate the efficacy of VP-102 by assessing the proportion of subjects who are 
clear at the Study Day 84 (EOT) Visit and remain clear at the Follow-up Visits on 
Study Day 112 and Study Day 147 (EOS). 
 
• To evaluate the efficacy of VP-102 by assessing the change from baseline in total 
wart area (sum of individual warts) at the scheduled post baseline visits Day 84, 
112 and 147. 
 
• To evaluate the efficacy of VP-102 by assessing the percent change from baseline 
in total wart area (sum of individual warts) at the scheduled post baseline visits 
Day 84, 112 and 147. 

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6.0 
STUDY DESIGN 
 
6.1 
Description of the Study 
 
This is a Phase 2, double-blind, placebo-controlled study to determine the dose 
regimen, safety, tolerability, and efficacy of VP-102 in subjects with EGW. This study 
is divided into two parts (Part A and Part B). The Schedule of Assessments and 
Procedures is presented in Table 1. 
 
6.1.1 
Part A (dose regimen finding) Study Design 
 
The aim of Part A is to determine the two best treatment regimens for evaluation of 
safety and efficacy in Part B. 
 
Treatment regimens will be evaluated based on the requirement to form blisters in most 
patients, while maintaining a favorable safety and tolerability profile (e.g., majority of 
LSR AEs are mild or moderate in severity). Accordingly, increasing durations of skin 
exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups 
(n=6/group) that will enroll progressively. 
 
Subjects will have a Screening Period of up to 14 days before the first treatment, 
followed by a Treatment Period starting at Treatment Visit 1 and lasting through 
Treatment Visit 4. 
 
Eighteen (18) subjects at up to six sites (additional sites may be added if required to 
ensure successful recruitment of the study population) will be enrolled, into either the 
2-hour (Group 1), 6-hour (Group 2), or 24-hour (Group 3) treatment duration of skin 
exposure groups (n=6 subjects/group). Each group will include a minimum of two 
subjects from each sex and will be randomized 5:1 (VP-102:placebo) within each 
group. All subjects will receive either VP-102 (containing 0.7% cantharidin [w/v] 
topical film-forming solution) or placebo. Warts are to be treated and then covered 
(unless prohibited by wart location) with transparent surgical tape (e.g., 3M™ 
Blenderm™ brand) that will remain on the skin until the designated time for removal. 
Subjects will be asked to remove the surgical tape and study drug with soap and water 
after the pre-determined duration of skin exposure for their group. 

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Study drug (VP-102 or placebo) will be administered once every 21 ±4 days for up to 
four applications. Enrollment will begin in Group 1, then proceed into Group 2, and 
lastly into Group 3. The enrollment of subjects into Groups 2 and 3 will only be allowed 
upon completion of a blinded review of the safety and tolerability data by a Safety 
Review Panel. The Safety Review Panel will be responsible for reviewing blinded 
safety and tolerability data and will provide determinations on trial stopping or 
modification rules. A blinded review of TEAEs, focusing on those of moderate or 
severe intensity, will be performed by the Safety Review Panel prior to opening 
enrollment for each subsequent cohort. This review will be conducted after the six 
subjects in a designated Group have completed the 48-hour (±8 hours) Visit. The Safety 
Review Panel will determine whether enrollment can be initiated into the next Group, 
OR if more data (e.g., waiting for additional treatments for enrolled subjects or the 
addition of more subjects to a group) are needed prior to making a determination to 
open enrollment into the next Group (i.e., the review conducted after six subjects have 
completed Group 1 could open enrollment into Group 2 and the review after Group 2 
could open enrollment into Group 3). An additional blinded safety review of TEAEs, 
focusing on those of moderate or severe intensity, will be performed after all six 
subjects in Group 3 have completed the 48-hour (±8 hours) Visit, in order to support 
dose selection for Part B (Safety and Efficacy). Safety Review Panel members are 
blinded to the treatment assignment. 
 
6.1.2 
Part B (safety and efficacy) Study Design 
 
Part B of the study will begin enrollment only after the Sponsor has selected the two 
dose regimens in Part A, which will be called VP-102 Regimen 1 and Regimen 2. In 
addition, written notification from the Sponsor must be provided to the sites prior to 
Part B enrollment. The study will remain blinded until completion of both parts of the 
study. 
 
Approximately 90 subjects at up to 9 sites (additional sites may be added if required to 
ensure successful recruitment of the study population) will be enrolled and randomized 
to one of four treatment arms. Randomization will be stratified by sex so that neither 
gender exceeds ~60% of any treatment arm (e.g., placebo group for the 6-hour and 
24-hour wash-off cannot have any one gender ≥ 60%). Two of the treatment arms will 
be VP-102 Regimen 1 and VP-102 Regimen 2. The other two treatment arms will be 
placebo (Placebo Regimen 1 and Placebo Regimen 2), with corresponding durations of 
skin exposure matching those selected for VP-102 Regimen 1 and Regimen 2. As an 

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example, if the regimens selected from Part A are the 2-hour and 6-hour applications 
of VP-102, then VP-102 Regimen 1 would be VP-102 treatment for 2-hours and VP-
102 Regimen 2 would be VP-102 treatment for 6-hours. Likewise, Placebo Regimen 
1 would be placebo treatment for 2 hours and Placebo Regimen 2 would be placebo 
treatment for 6-hours. Randomization of the four treatment arms (VP-102 Regimen 
1:VP-102 Regimen 2: Placebo Regimen 1:Placebo Regimen 2) will be 3:3:2:2. 
 
In both Regimen 1 and Regimen 2, study drug will be administered to EGW once every 
21 ±4 days for up to four applications. Subjects will be asked to remove the surgical 
tape and study drug with soap and water at the designated time selected from the dose 
regimen findings in Part A of the study. 
 
6.1.3 
Part A and Part B Procedures 
 
6.1.3.1 
Subject Participation 
 
Pre-study screening for eligibility (informed consent, demographics, physical exam, 
vital signs, prior and concomitant medications, and medical history) can occur up to 
14 days before, or on the same day as Treatment Visit 1. The dermatologic exam, wart 
count, wart measurement (diameter), location of all warts, and photographs (if 
applicable) must be repeated at Treatment Visit 1 if the Screening Visit is not conducted 
on the same day. Warts must measure ≤ 8 mm in diameter each with a total wart area 
(i.e., all warts combined) ≥ 10 mm2 at baseline. Wart count must be ≥ 2 and ≤ 30 total 
warts within the allowed treatment areas at the time of Treatment Visit 1. 
 
Subjects who do not continue to meet criteria at Treatment Visit 1 will be considered a 
screen failure and will be treated at physician discretion per standard of care. Subjects 
who meet the enrollment criteria will be randomized to receive VP-102 or placebo. 
Treatment will continue with a minimum of every 21 ±4 days, until complete clearance 
or a maximum of four treatment sessions. The exact treatment interval will be 
determined by evaluation of the treatment site and take any ongoing LSRs into account. 
Subjects who achieve complete clearance of all treatable warts before Treatment Visit 4 
will be required to return for every scheduled, in-person, treatment and follow-up visit, 
whether or not their warts have cleared. The 24-hour, 7-day, and 14-day evaluation of 
response to treatment (ERT) telephone follow-ups will be conducted per protocol for 
those instances in which the subject was treated. 

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6.1.3.2 
Efficacy Procedures 
 
All required study activities, including an ERT (i.e., assessment of wart activity [count, 
location, diameter] and related LSRs), will be conducted per protocol. A Blinded 
Assessor will perform wart counts before the ERT assessment at Treatment Visit 2, 
Treatment Visit 3, Treatment Visit 4, End of Treatment Visit, and Follow-up Visit. 
 
Treatment visits are to take place in order (i.e., Treatment 1, Treatment 2, Treatment 3, 
and Treatment 4). All subjects will receive application of study drug to EGW, including 
an approximate margin of healthy surrounding skin, at an interval of every 21 ±4 days 
until complete clearance of all treatable warts, or a maximum of four applications. 
 
No partial treatment of warts (e.g., treating one wart and not another) is permitted. In 
any instance where the clinician is uncertain if a residual wart is remaining, treatment 
should be applied. Instructions for application of the study drug are outlined in the 
Instructions for Use included in the drug shipment, as well as included in the Site 
Regulatory Packet. 
 
Subjects should be re-treated only after 17 to 25 days (i.e., 21 ±4 days) have elapsed 
since the previous treatment and only after any LSRs have resolved sufficiently to allow 
evaluation of the treatment site. Treatment should only take place at a visit when all 
warts are evaluable (i.e., not obscured by an ongoing LSR). All warts that are not 
completely clear should undergo treatment with study drug. Subjects exhibiting skin 
reactions that need additional time, at the Investigator’s discretion, before they can be 
treated again will be evaluated and asked to return for their next treatment visit after 
the area is considered sufficiently resolved to allow for the next treatment (e.g., ongoing 
dryness or erythema is appropriate to treat). See instructions below regarding 
unscheduled visits. 
 
Subjects who receive <4 treatments within the treatment period, or have visits that are 
outside of the visit window due to the duration of post-treatment LSRs, will not be 
considered a protocol deviation. In the event that a subject misses a treatment visit, and 
is outside the 4-day study window, they may return and be treated at the next available 
opportunity with the subsequent visit scheduled 21 ±4 days after the actual treatment 
visit. No treatment should be administered after the treatment period without the 
Sponsor’s approval. 

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An ERT assessment will be conducted at each treatment visit (1-4; in-person before 
treatment or via follow-up telephone calls) at 24 hours (±6 hours), 7 days (±24 hours), 
and 14 days (±24 hours) after each treatment visit (not “unscheduled” visits). Note that 
the ERT telephone calls at 24 hours (±6 hours), 7 days (±24 hours) and 14 days 
(±24 hours) are not required if there was no treatment during that period. In Part A 
Treatment Period 1 only, subjects will return to the clinic for an in-person ERT 
assessment at 48 hours (±8 hours) after Treatment Visit 1. The ERT includes questions 
related to removal of surgical tape and study drug (if applicable) and collects any new 
AEs, LSRs, and changes in concomitant medications since the last contact. The subject 
will be given an opportunity to ask questions and review any concerns. In the event that 
any post-treatment LSR presents a safety concern (including but not limited to severe 
blistering, ulceration, edema, or pain) an “Unscheduled” clinic visit must be scheduled, 
and the subject assessed accordingly. In addition, if any post-treatment AEs present a 
safety concern, the subject may be brought in for an unscheduled visit. The ERT 
assessments will be recorded by a research team member on the ERT form. The ERT 
visits may not be conducted by a person designated as a Blinded Assessor. Phone calls 
conducted outside of the required study visits or required ERT assessments should be 
documented in the subject’s source note but are not required to be entered in the 
electronic data capture (EDC) system. 
 
ERT assessments, wart count, and wart location will be conducted before treatment 
application at all Treatment Visits 1 to 4, as well as at the EOT Visit on Study Day 84 
(0/+8 days) and at the Follow-up Visits on Study Day 112 (±7 days) and Study Day 147 
(±7 days). Wart measurement will be conducted before treatment application at 
Treatment Visit 1, as well as at the EOT Visit on Study Day 84 (–0/+8 days) and at the 
Follow-up Visits on Study Day 112 (±7 days) and Study Day 147 (±7 days). Subjects 
who clear all warts before the Study Day 84 (EOT) Visit will still be required to return 
for each of the scheduled in-person treatment visits, as well as the Study Day 84 (EOT) 
Visit, the Study Day 112 follow-up visit, and the Study Day 147 (EOS) Visit. A 
Provider Treatment Questionnaire will be completed at the Study Day 84 (EOT) Visit 
by a clinician who applied treatment to the subject during the course of the study. All 
subjects will continue in the study for two additional Follow-up Visits on Study 
Day 112 and Study Day 147 (EOS). 
 
All treatment visits will include a wart count, performed before treatment (if applicable) 
and before ERT assessment. No treatment will be required if the wart is considered 
clear. Genital warts that develop in areas that are unable to be treated, (e.g., close to a 

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mucous membrane) and other wart types (e.g., common warts) will not be evaluated, 
documented, or considered in the analysis. 
 
Wart counts will be conducted at the Screening Visit, Treatment Visit 1, Treatment 
Visit 2, Treatment Visit 3, Treatment Visit 4, End of Treatment Visit, and Follow-up 
Visit by a trained member of the study team. Other than the screening visit and Day 1, 
wart counts will also be conducted by a member of the research team that has been 
identified and trained as a Blinded Assessor. The Blinded Assessor may be utilized for 
a subject’s initial screening, enrollment and treatment Visit 1 activities, however, may 
not perform any other study related activities other than wart counts at subsequent visits 
(e.g., follow-up phone calls or unscheduled visits) for the same subject. The Blinded 
Assessor is not required to be the same person for each assessment. 
 
It can sometimes be challenging to determine if a wart is completely clear after 
treatment due to ongoing LSRs. At any visit in which the Investigator is unable to 
evaluate or treat some warts due to ongoing LSRs, an “Unscheduled” visit should be 
documented. The timing of the next visit will be determined by the resolution of the 
LSR. The research team should be in contact with the patient until LSRs are resolved 
sufficiently and a treatment visit can be scheduled within 21 ±4 days when possible. 
Specific instructions on how to conduct the initial wart count and measure wart 
diameter will be provided during Investigator training. 
 
At designated sites, photography will be offered to volunteer subjects who consent to 
participate. Photography will take place at the clinical site at each treatment and 
follow-up study visit through Study Day 147 (±7 days; EOS). If there are no warts 
remaining, the same areas will be photographed and repeated at the Study Day 84 
(0/+8 days) EOT Visit and Study Day 147 (±7 days) EOS visit, regardless of whether 
warts are present. The images may be used on handouts in future trials, for training 
purposes, or future marketing materials. They will not be used for any portion of the 
efficacy or safety data. Photographs will be de-identified to those outside the research 
team and stored in a Health Insurance Portability and Accountability Act (HIPAA) 
compliant manner. Efforts will be made to ensure that no photographs with identifiable 
features are obtained. 

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6.1.3.3 
Safety Procedures 
 
Subjects will be provided with take home instructions describing what they might 
expect throughout the course of the study, as well as recommendations for wound care 
(if needed), when it is important to call their doctor, and instructions for who to contact 
in an emergency. In the event that any post-treatment LSR presents a safety concern 
(including but not limited to severe blistering, ulceration, edema, or pain), an 
“Unscheduled” clinic visit must be scheduled and the subject assessed accordingly. In 
addition, if any post-treatment AEs present a safety concern, the subject may be brought 
in for an unscheduled visit. 
 
An LSR guide for subjects, with specific photographs representing the various skin 
reactions and examples of intensity, will be provided and reviewed in detail at the clinic 
with the subject by the research team. The LSR guide will be utilized for reference by 
the subject during the ERT follow-up telephone assessments with the research team 
member. The final determination of LSR parameters, including intensity, will be made 
by the research team member. 
 
6.2 
Number of Subjects 
 
In Part A, 18 subjects will be enrolled into one of three duration of skin exposure groups 
(n=6 subjects/group). Each group will include a minimum of two subjects from each 
sex and will be randomized 5:1 (VP-102:placebo) within each group. 
 
In Part B, 90 subjects will be enrolled, randomized to one of four treatment arms. 
Randomization will be stratified by sex so that neither gender exceeds ~60% of any 
treatment arm (e.g., placebo group for the 6-hour and 24-hour wash-off cannot have 
any one gender ≥ 60%). 
 
6.3 
Measures Taken to Minimize Bias 
 
Bias is minimized by subject randomization and blinding (Section 6.5). 
 
6.4 
Expected Duration of Subject Participation 
 
Study duration from Treatment Visit 1 through the final follow-up visit is 
approximately 147 days (21 weeks). The length of study participation is approximately 

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84 (–0/+8) days for the EOT assessment (primary endpoint) and Study Day 147 (±7) 
days to complete the study, in addition to the screening visit of up to 14 days before 
study drug administration. The study will consist of up to four applications of study 
drug at intervals of 21 ±4 days. All treatments will take place within a 75-day period. 
No treatment should be administered after Day 75 without the Sponsor’s approval. 
Post-treatment Follow-up Visits on Study Day 84 (–0/+8 days) (EOT), Study Day 112 
(±7 days),), and Study Day 147 (±7 days) are included for subjects to evaluate the 
durability of treatment response over time. 
 
6.5 
Method of Treatment Assignment and Blinding 
 
After informed consent has been obtained, subjects will be screened for study eligibility 
before randomization. Subjects will be assigned a subject number and randomized. In 
Part A, each group will include a minimum of two subjects from each sex randomized 
5:1 (VP-102: or placebo). In Part B, randomization of the four treatment arms (VP-102 
Regimen 1:VP-102 Regimen 2: Placebo Regimen 1:Placebo Regimen 2) will be 
3:3:2:2. The study site’s pharmacist (or pharmacist designee) will obtain the study drug 
assignment from the Interactive Response Technology (IRT). A subject is considered 
randomized when the randomization transaction is recorded in the IRT. 
 
The Sponsor will remain blinded to study medication assignment until the study is 
completed and the database is locked, with the exception of cases in which unblinding 
is required due to a safety or tolerability issue. In the case of a medical emergency 
requiring the PI to know the identity of the study drug, the PI will follow the procedures 
outlined in Section 8.6. 

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7.0 
SELECTION, DISCONTINUATION, AND WITHDRAWAL OF SUBJECTS 
 
The study will enroll and treat approximately 18 adult subjects in Part A and 
approximately 90 subjects in Part B presenting with EGW and a wart count of 2 to 30, 
inclusive. Eligibility to participate in the study will be determined by the Investigator 
on the basis of the inclusion and exclusion criteria. 
 
7.1 
Subject Inclusion Criteria 
 
To qualify for inclusion in this study, subjects must: 
 
1. 
Be healthy, immunocompetent males or females ≥ 18 years of age 
 
2. 
Present with ≥ 2 and ≤ 30 external genital and/or perianal warts in ≥ 1 of the 
following anatomic areas: 
a. In both sexes: medial thigh (except inguinal fold); supra-pubic, perineal, and 
perianal areas 
 
b. In men: over the glans penis (excluding urethral meatus), penis shaft, 
scrotum, and foreskin 
 
c. In women: vulva (excluding labia minora and mucosal surfaces) 
 
3. 
Have warts present for ≥ 4 weeks at the baseline visit 
 
4. 
Have warts that are ≤ 8 mm in diameter each with a total wart area (i.e., all warts 
combined) ≥ 10 mm2 
 
5. 
Be free of any systemic or dermatologic disorder, that, in the opinion of the 
Investigator, will interfere with the study conduct, efficacy assessments, or 
increase the subject’s risk of AEs 
 
6. 
Refrain from swimming, bathing, or prolonged immersion in water or any other 
liquids until the study drug is removed 
 
7. 
Have the ability to follow study instructions and be likely to complete all study 
requirements 

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8. 
Agree to use no wart-removing product (prescription or over-the-counter, 
including any HPV immunization) other than the study drug during the course of 
the study 
 
9. 
Provide written informed consent in a manner approved by the IRB and 
evidenced by the signature on an IRB approved consent form 
 
10. Provide written authorization for use and disclosure of protected health 
information 
 
11. If participating in the optional photographic portion of the study, agree to allow 
photographs of warts to be taken at each treatment and all follow-up visit by the 
research team 
 
7.2 
Subject Exclusion Criteria 
 
Candidates will be excluded from the study if they: 
 
1. 
Are unable to cooperate with the requirements or visits of the study, as 
determined by the Investigator 
 
2. 
Have a wart within the allowed treatment area > 8 mm in diameter or with an 
eroded or ulcerated surface, in the Investigator’s opinion 
 
3. 
Have an unclear diagnosis of condyloma 
 
4. 
Have warts outside of the allowed treatment area (e.g., cervical, vaginal, clitoral, 
rectal, within 2 mm of anus) that require treatment during the planned study 
period or are undergoing treatment in the last 4 weeks 
 
5. 
Have any wart types other than genital warts (e.g., common or plantar warts) that 
require treatment during the study period 
 
6. 
Have a history of genital infections or diseases within 4 weeks before enrollment 
 
7. 
Have active genital herpes eruption, or had active genital herpes lesions within 
4 weeks before enrollment 
 
8. 
Have a history of HPV-associated malignancies within the last 5 years 

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9. 
Have a dermatologic disease (e.g., psoriasis) or skin condition in the wart areas 
that may cause difficulty with examination 
 
10. Are systemically immunosuppressed or have required, or will require, systemic 
immunosuppressive or immunomodulatory medication (including oral or 
parenteral corticosteroids) within 30 days before enrollment or during the course 
of the study (routine use of local [e.g., topical, inhaled, or intranasal] 
corticosteroids during the study is allowed) 
 
11. Have any chronic or acute medical condition that, in the opinion of the 
Investigator, may interfere with the study results or place the subject at undue risk 
(e.g., human immunodeficiency virus, systemic lupus erythematosus, viral 
hepatitis, diabetes, clinically significant medical, psychiatric, or emotional 
condition or abnormality). 
 
12. Have had HPV immunization within the last 3 months prior to enrollment. 
(NOTE: HPV may NOT be administered during the course of the trial. Other 
immunizations (e.g., flu shots) may be administered throughout the study, but not 
within 5 days before or after treatment. 
 
13. Have had any previous treatment (including an investigational agent in a clinical 
trial) of genital warts, including but not limited to the use of imiquimod, 
antivirals, retinoids, salicylic acid, lactic acid, hydrogen peroxide, iodine-based 
or nitric oxide-based therapies, curettage, or freezing of warts in the 14 days 
before screening; in addition, these treatments, or any other over-the-counter wart 
treatment, should not be implemented during the study. The wash out period for 
cantharidin, candida antigen, diphencyprone, dinitrochlorobenzene, squaric acid 
dibutyl ester and any other immunomodulating treatment not otherwise specified 
is 30 days before the Screening Visit. 
 
14. Have history of, or current, epidermodysplasia verruciformis 
 
15. Have an active malignancy or are undergoing treatment for any malignancy 
 
16. Have a history or presence of hypersensitivity or an idiosyncratic reaction to 
VP-102 (including cantharidin or related compounds) or study drug product 
excipients (acetone, ethyl alcohol, nitrocellulose, hydroxypropyl cellulose, castor 
oil, camphor, gentian violet, and denatonium benzoate) 

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17. Have a condition or situation that may interfere significantly with the subject’s 
participation in the study (e.g., subjects who required hospitalization within 
2 months before screening for an acute or chronic condition including alcohol or 
drug abuse), at the discretion of the Investigator 
 
18. Are sexually active or may become sexually active and are unwilling to practice 
responsible birth control methods (e.g., birth control pills, intrauterine device, 
patch, shot, vaginal ring, and combination of condoms and foam); NOTE that 
withdrawal and/or sterilization of self or partner are not acceptable methods of 
birth control. Females that have reached menarche must have a negative urine 
pregnancy test at each study visit before treatment with study drug 
 
19. Are pregnant or breastfeeding 
 
7.3 
Requalification for Entry 
 
Subjects not fulfilling the entry criteria and not randomized may be rescreened for 
participation if their eligibility characteristics have changed. 
 
7.4 
Subject Withdrawal Criteria 
 
Subjects are encouraged to complete the study, but can withdraw consent at any time 
during the study and for any reason without any penalty or changes to care. The 
Investigator will provide a written explanation of the reason for discontinuation in a 
source document and this information will also be recorded on the appropriate 
electronic case report form (eCRF) page. If a subject withdraws before completion, 
every effort should be made to complete the EOS (Study Day 147) assessments 
scheduled during the EOS visit. 
 
A subject may be withdrawn from the study for the reasons described in Section 7.4.1 
through Section 7.4.5. 
 
Data collected to the point that the subject withdraws or is withdrawn are still 
assessable by the Investigator. If subjects do not want their data that has already been 
submitted, they will need to submit a request in writing to the Investigator for removal 
of their information. 

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7.4.1 
Adverse Event 
 
If a subject experiences an AE that, in the judgment of the Investigator, the Sponsor, 
or the Medical Monitor, presents an unacceptable consequence or risk to the subject, 
the subject may be discontinued from the study. 
 
7.4.2 
Intercurrent Illness 
 
A subject may be discontinued from the study if, in the judgment of the Investigator, 
the subject develops an intercurrent illness or complication that is not consistent with 
the protocol requirements or that, in any way, justifies withdrawal from the study. 
 
7.4.3 
Noncompliance 
 
After the Investigator, the Medical Monitor and/or Study Monitor consult (and the 
Sponsor if appropriate), a subject may be discontinued from the study for the following 
administrative reasons: 
 
• 
Failure to receive study medication or treatment as mandated by the specific 
instructions provided in Section 8.0. 
 
• 
Failure to comply with protocol requirements 
 
7.4.4 
Refusal of Investigational Product Administration 
 
Any subject refusing clinical trial material for any reason will be discontinued from the 
study, and the reason(s) for their discontinuation will be documented on the appropriate 
eCRF page. Reasonable efforts should be made to monitor the subject for AEs and to 
complete follow-up assessments after treatment discontinuation. These efforts should 
be documented on the appropriate eCRF page. 
 
7.4.5 
Withdrawal of Consent 
 
Any subject who withdraws consent for any reason at any time during the study will be 
discontinued from the study, and the reason(s) will be documented on the appropriate 
source and eCRF page. If subjects do not want their data that has already been 
submitted, they will need to submit a request in writing to the Investigator for removal 
of their information. 

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7.5 
Replacement of Subjects 
 
Subjects prematurely withdrawn from the study as dropouts (e.g., enrolled in the study 
but never received study drug, did not complete the EOT and EOS assessments), for 
noncompliance, or who request to be withdrawn from the study may be replaced at the 
discretion of the Sponsor. 
 
7.6 
Premature Study or Site Termination 
 
If the Sponsor, Investigator, Medical Monitor, Study Monitor, or appropriate regulatory 
officials discover conditions arising during the study that indicate that the study should 
be halted or that the site should be terminated, this action may be taken by the Sponsor 
after appropriate consultation among the Sponsor, Investigator, Medical Monitor, and 
Study Monitor. Conditions that may warrant termination of the study include, but are 
not limited to, the following: 
 
• The discovery of an unexpected, serious, or unacceptable risk to the subjects 
enrolled in the study 
• A decision on the part of the Sponsor to suspend or discontinue testing, evaluation, 
or development of the product 
• Termination of study conduct at an individual site may also be warranted under the 
following conditions: 
− 
Failure of the Investigator to enroll subjects into the study at an acceptable rate 
− 
Failure of the Investigator to comply with pertinent regulations of appropriate 
regulatory authorities 
− 
Submission of knowingly false information from the site to the Sponsor, Study 
Monitor, or appropriate regulatory authority 
− 
Insufficient adherence to protocol requirements 
 
Study termination and follow-up will comply with the conditions set forth in 
International Council for Harmonisation (ICH) E6, Guideline for GCP. Data from all 
sites, including those that have been terminated for non-compliance or unsatisfactory 
enrollment will be evaluated and included in the interpretation of study findings. 
Subjects from sites that terminate early will be considered for analysis. If a subject does 
not complete the study, they will still be counted as a failure for the primary endpoint. 

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8.0 
STUDY DRUGS 
 
8.1 
Investigational Agent and Placebo 
 
The VP-102 single-use applicator contains 0.45 mL of 0.7% w/v cantharidin. The 
placebo single-use applicator is comprised of the same formulation as the VP-102 
applicator but does not contain the active pharmaceutical ingredient cantharidin. 
 
Although the study drug will be labeled exclusively for topical application, the 
formulation also contains an oral deterrent (denatonium benzoate) to further help 
mitigate the risk of accidental ingestion. The study drug is light violet to dark purple in 
color and has been manufactured under GMP. 
 
Each lot of applicators will be released for clinical use after a subset has undergone 
applicator suitability testing and demonstrated that they can deliver drug product in a 
controlled manner, without leaking or spilling. After the commercial product completes 
all required testing, they will be released for use in the clinical study. 
 
8.2 
Directions for Use 
 
8.2.1 
Application of Study Drug and Surgical Tape 
 
Study drug (VP-102 or placebo) is contained within a single-use applicator. Per 
protocol, one applicator may be used to treat all EGW lesions at each subject treatment 
visit. 
 
Following examination, the product is applied to the skin as a viscous solution, at which 
point the solvents evaporate, leaving behind a thin, flexible, and resilient film. Study 
drug will be applied in sufficient quantity to cover the entirety of each wart, including 
approximately a 1 mm margin of surrounding, healthy skin. Observe subjects for 2 to 
5 minutes after study drug application or until the film is formed and totally dry. 
 
Surgical tape should be applied to lesions that have been treated and gently rubbed in 
order to maximize adherence to the treated area. Tape MUST NOT be applied until the 
product is completely dry (approximately 2-5 min). The size of the piece (or pieces) of 
surgical tape used is based upon Investigator discretion, provided that all treated warts 
are covered, and the surgical tape size is deemed sufficient to maintain adherence for 

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the assigned duration of skin exposure. An adhesive bandage may be applied over the 
surgical tape if needed for flexible areas. It may not be feasible to apply tape to some 
anatomical locations, in which case an adhesive bandage may be used, when possible, 
to protect other skin sites from coming into contact with the treated area. 
 
Given the length of time or complexity it may take to treat all warts, Investigators will 
assess, in advance, if subjects will be able to complete treatment in one treatment 
session. Application of study drug may not be conducted over more than one visit. 
Subjects may be rescheduled for the first treatment, as long as it is within the 14-day 
screening time period. Otherwise, they will need to be rescreened and consent reviewed 
to participate. 
 
All subjects will be provided a copy of their signed Informed Consent Form (ICF). At 
each treatment visit, the subjects will be provided with both verbal and written take-
home instructions covering potential side effects and complications, as well as contact 
information of the study Investigator/ Coordinator for any questions or concerns that 
may arise. Subjects will also be provided an LSR guide to assist the site in collecting 
the required ERT information related to the treated areas. Subjects should refrain from 
touching, licking, or biting treated skin or putting treated skin in or near any mucosal 
surface including the mouth, nostrils, eyes, and anogenital area for up to 48 hours 
after treatment or until the study drug is removed. Strongly urge subjects not to touch 
or wash the treated area for the assigned duration of skin exposure. 
 
Subjects will receive application of study drug to all warts with a minimum of 
21 ±4 days between   treatment   until   complete   clearance   or   a   maximum   of 
4 applications. The exact treatment interval will be determined by evaluation of the 
treatment site and take any ongoing LSRs into account. 
 
Please see the Instructions for Use provided in each subject-specific kit, as well as your 
regulatory file, for step-by-step instructions. 
 
8.2.2 
Removal of Surgical Tape and Study Drug 
 
All subjects will have reviewed and are provided with take home instructions on 
removal of the surgical tape and study drug, as well as descriptions of the potential 
LSRs they might expect throughout the course of the study; recommendations for 

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wound care, when it is important to call their doctor, and instructions for whom to 
contact in an emergency. 
 
Surgical tape should only be removed at the designated times after study drug 
application, when the treatment site is washed and study drug removed. 
 
Subjects are instructed to wet the surgical tape in a bath or shower with water and then 
slowly peel back an edge of the surgical tape, pulling the surgical tape over itself in a 
“low and slow” manner to prevent the unroofing of any blisters that may have 
developed. Gently remove any remaining study drug with soap and water. Subjects will 
be cautioned not to use washcloths, abrasive material, or vigorous rubbing to remove 
the study drug, as this may cause temporary pain and damage to the external layer of 
the skin and slow the healing process. Subjects are encouraged to wash their hands 
regularly with soap and water and discouraged from scratching lesions, which can 
spread disease. 
 
Note: The surgical tape and study drug may be gently removed from individual warts 
before the designated time in the event of significant blistering, significant pain, or a 
TEAE. Study drug should not be removed from any remaining unproblematic warts 
until the designated removal time is reached. Subjects who remove study drug before 
the assigned time frame will be considered a protocol deviation, unless early removal 
is due to protocol defined criteria. 
 
Early removal is defined as removal of study drug outside of the following windows: 
 
• ±1-hour window for 2-hour duration of skin exposure group 
 
• ±2-hour window for 6-hour duration of skin exposure group 
 
• ±6-hour window for 24-hour duration of skin exposure group 
 
8.3 
Study Drug Storage 
 
Clinical sites will be provided with an initial supply of subject specific kits containing 
4 single-use applicators. Each applicator contains 0.45 mL of study drug (VP-102 or 
placebo) and is individually packaged in a UV protected, zip-top bag. Each bag is 
labeled with all pertinent product information including the corresponding kit number 
it is assigned to. Applicators are not numbered in sequential order, but each should be 

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documented on the drug accountability form as they are used. The zip-top bag should 
not be opened until the site is ready to initiate treatment. Do not dispose of the zip top 
bag, as it will be used to store the used applicator (Section 8.9). 
 
Study drug must be stored at controlled room temperature (68°F-77°F). Short term 
storage temperature excursions between 59°F-86°F that are experienced in the 
physician’s storage area and/or during shipping are allowed, provided the mean kinetic 
temperature remains below 25oC. Excursions from 38°F to 59°F that do not result in 
precipitate formation are acceptable for use. Short term storage temperature excursions 
(spikes less than 24 hours in duration) between 86°F to 104°F may be allowed but must 
be evaluated for impact by the Sponsor before use. Storage temperature excursion 
above 104°F are not allowed and will require replacement of the study drug. The study 
drug must be stored in a secure, dry location with limited and controlled access, and 
out of direct light. Extended exposure to extreme temperature conditions or to direct 
light should be avoided (e.g., study drug left in an unoccupied vehicle in a hot or cold 
environment). Contact the study Sponsor or designee (i.e., clinical research 
organization) in the event that you believe that any materials may have been exposed 
to such conditions for guidance. Study drug may be administered only by the 
Investigator or by a trained member of the clinical site staff specifically as authorized 
by the Investigator. 
 
Stability studies with VP-102 ampules have shown that they are stable for 18 months 
under controlled room temperature conditions. Therefore, this product is considered 
stable for at least 30 months under the recommended storage conditions. Stability 
studies are ongoing and may extend the expiration date. In the event there are any 
changes in extension of the expiration date, sites will be notified by the Sponsor 
accordingly. 
 
8.4 
Study Drug Labeling 
 
Study drug is packaged in tamper evident, subject-specific kits, within a cardboard 
carton, that contains 4 individually packaged applicators. Each applicator is 
individually contained in UV protected and labeled zip-top pouch. 
 
The applicator is labeled with the IND application number and study protocol number. 
An example of the applicator label is presented in Figure 1. 

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The label also indicates the date of manufacture and includes the required statements 
“Caution: New Drug--Limited by Federal Law to Investigational Use.” and “Warning: 
Flammable Liquid.” The applicator warnings indicate characteristics of the study drug 
including additional labeling “Warning: Flammable Liquid” and the yellow toxic 
chemical symbol with the phrase “Warning: Highly Toxic”. 
 
The pouch label includes the IND number, study protocol number, warnings that 
include how to address inadvertent contact in the eye and the applicator assigned 
subject specific kit/randomization number. The pouch label can be seen below in 
Figure 2. 
 
The subject specific kit label includes the same information as indicated on the pouch 
including the subject specific kit and randomization number. Please confirm the pouch 
matches the number on the outside of the kit box prior to using. The kit label can be 
seen in Figure 3. 
 
In an effort to make it easier for the research personnel to ensure they have pulled the 
correct box at each study visit, a 4th label has been added to the side of the kit box 
providing a space for the research team to write in the randomization number. This 
label is shown in Figure 4. 

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Clinical Trial Labeling of Study Drug 
Figure 1. 
Label on Applicator 
 
 
 
 
 
Figure 2. 
Label on Pouch Containing Each Applicator 

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Figure 3. 
Kit Top Label 
 
 
Figure 4. 
Kit Side Label 
 

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8.5 
Compliance 
Treatment compliance for study drugs will be documented in the eCRF by recording 
the date, subject identification, and kit number. 
 
8.6 
Breaking the Blind 
This study is a double-blind design. Blinded subjects, Investigators, site staff, and 
Sponsor personnel will not make any effort to determine which study drug therapy is 
being applied. 
 
In the event that unblinding of the study drug assignment is necessary for emergency 
treatment, it is required that the Investigator contact the Medical Monitor immediately. 
Following the discussion on the urgency and requirement for knowing the exact 
treatment, the Medical Monitor will determine whether to unblind and provide the 
treatment assignment to the Investigator. All unblinding will be reported to the 
Sponsor. 
 
8.7 
Previous and Concomitant Medications 
 
All medications taken within 14 days prior to the first dose of the study drug will be 
classified as prior medication; while all medications used after the first dose of study 
drug will be classified as concomitant medications. Prior and concomitant medications 
will be recorded in the eCRF, along with the reasons for administration and durations 
of use. 
 
Treatment of warts with any prescription or over-the-counter wart medication 
(including any HPV immunization), curettage, or freezing of warts should not be 
implemented during the study. Treatments for genital warts include, but are not limited 
to, the use of cantharidin, antivirals, retinoids, salicylic acid, lactic acid, hydrogen 
peroxide, candida antigen, diphencyprone, dinitrochlorobenzene, sandalwood oil, thuja 
oil, squaric acid dibutyl ester, povidone iodine, nitric oxide, any other over-the-counter 
wart treatment; curettage; or freezing of warts. 
 
Potential subjects who are systemically immunosuppressed or have required, or will 
require, systemic immunosuppressive or immunomodulatory medication (including 
oral or parenteral corticosteroids) within 30 days before enrollment or during the course 

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of the study will be excluded. Note that routine use of local (e.g., topical, inhaled, or 
intranasal) corticosteroids during the study is allowed. 
 
Immunizations and flu shots may be administered throughout the study but not within 
5 days before or after treatment. 
 
8.8 
Accountability Procedures 
The pharmacy or trained study personnel are responsible for ensuring that a current 
record of study drug inventory and accountability is maintained. The unique kit 
numbers on the pouch and kit labels are used for accountability purposes and are 
recorded on the accountability log as they are used. 
 
The assigned research personnel and study monitor will be responsible for verifying 
drug accountability at the site. Inventory records must be readily available for 
inspection by regulatory authorities at any time. Upon receipt of study drug, the 
pharmacy or study personnel will visually inspect the shipment and verify the number 
and condition of kits received. The site will record the receipt of their inventory in the 
IRT system. All shipping records will be maintained in the IRT system. 
 
8.9 
Study Drug Handling and Disposal 
 
Used applicators are not to be discarded after use, but should be returned to their zip-top 
bag and stored in the subject-assigned kit box. All used applicators are to be discarded 
at the site in a sharps container, or per the site’s standard operating procedure (SOP) 
for disposal, after the Study Monitor has reviewed and confirmed accurate 
accountability. Those sites that are not allowed to dispose of the study drug at their site 
will make arrangements with the Sponsor for return and destruction. All unused 
applicators and/or kits are to be returned to the drug distribution center after 
accountability is completed and the Study Monitor has completed the corresponding 
paperwork to direct the return. 

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9.0 
SUBJECT PROCEDURES 
 
Each subject will be evaluated and treated as follows: 
 
9.1 
Subject Restrictions 
Subjects are required to: 
 
• Use no wart-removing product (prescription or over-the-counter and including any 
HPV immunization) other than the study drug during the course of the study 
 
• Refrain from sexual activity involving the treated area as well as touching, licking, 
or biting treated skin or putting treated skin in or near any mucosal surface 
including the mouth, nostrils, eyes, and anogenital area for at least 48 hours after 
treatment or until the study drug is removed 
 
• Refrain from swimming, bathing, or prolonged immersion in water or any other 
liquids until the study drug is removed 
 
9.2 
Screening Period (up to 14 days before first treatment) 
 
Before the initiation of screening assessments, the subject must be given a complete 
explanation of the purpose and evaluations of the study. Subsequently, the subject must 
sign and receive a copy of an IRB-approved ICF and an authorization for use and 
disclosure of protected health information that was approved by the IRB (Section 13.0). 
Once consent is obtained, the Screening Period assessments will be performed. 
Subjects will be screened within 14 days prior to or on Treatment Visit 1 of the study. 
 
• Obtain signed informed consent prior to initiating any study-related assessments or 
procedures 
 
• Obtain relevant medical history (including HPV immunization) within the past 
5 years 
 
• Obtain genital wart history (duration and previous treatments); if treated, confirm 
date of last treatment. Warts must be present for ≥ 4 weeks before screening. 
 
• Clinical assessments 
− Conduct limited physical examination 

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− Record demographics (date of birth, sex, race, and ethnicity) 
− Measure height and weight 
− Measure vital signs (temperature, heart rate) 
 
• Wart assessments 
− Wart count 
− Wart location by anatomical location 
 
• Wart measurement (diameter and area); 
• Dermatologic exam including Fitzpatrick Skin Type 
 
• Photography 
 
• Subjects who agree to participate in the photographic portion of the study will have 
photographs of warts taken before treatment by the study team. Confirm that the 
subject meets all inclusion criteria and does NOT meet any exclusion criteria 
 
• Record 
all 
prior 
medications 
(including 
non-prescription 
and 
herbal 
[complementary medicine] products) within the last 14 days before Screening; 
− Record any antimicrobial, antiviral, steroidal, or topical drugs received within 
30 days before Day 1. 
− Record any non-pharmacologic treatments (e.g., ice packs, heat packs, warm 
soaks, etc.) administered in the 72 hours before application of study drug. 
 
9.3 
Treatment Period 
 
Treatment visits will occur every 21 ±4 days. All treatments may be administered over 
the course of up to 75 days. 
 
9.3.1 
Treatment Period 1 
 
The following evaluations will be performed and recorded in the eCRF. 

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9.3.1.1 
Day 1 (Treatment Visit 1) 
 
Screening and Treatment Visit 1 may occur on the same day. If the Screening Visit and 
Treatment Visit 1 are not on the same day, repeat the following procedures: 
 
• Confirm that subject still meets enrollment criteria (dermatologic exam; ability to 
attend study visits) 
 
• Obtain relevant medical history since Screening Visit 
 
• Obtain genital wart history (duration and previous treatments) since Screening 
Visit; if treated, confirm date of last treatment 
 
• Clinical assessments 
− Measure vital signs (temperature, heart rate) before application of study drug 
• Wart assessments (wart count, location by anatomical location, wart diameter 
measurement) conducted before application of study drug 
− Conducted by a study team member who is not considered, or has not acted as, 
the Blinded Assessor for the subject throughout the subject’s participation 
• Dermatologic exam 
 
• Photography before application of study drug 
− Subjects who previously agreed to participate in the photographic portion of the 
study will have photographs of warts taken by the study team 
• Record any 
prior medications (including non-prescription and herbal 
[complementary medicine] products) since the Screening Visit 
− Record any antimicrobial, antiviral, steroidal, or topical drugs received within 
30 days before Day 1. 
− Record any non-pharmacologic treatments (e.g., ice packs, heat packs, warm 
soaks, etc.) administered in the 72 hours before application of study drug. 

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The additional procedures listed below are also completed as part of Treatment Visit 1: 
 
• Laboratory assessments 
− Perform urine pregnancy test on female subjects of child-bearing potential (i.e., 
females who are capable of menstruating) before study drug application 
• ERT assessment conducted before study drug application 
− All ERT safety assessments must be conducted and recorded on ERT by a 
qualified member of the research team; ERT assessments must be conducted by 
a study team member who is not considered, or has not acted as, the Blinded 
Assessor for the subject throughout the subject’s participation 
− Warts that develop in areas that are unable to be treated, (e.g., close to a mucous 
membrane) will not be evaluated, documented, or considered in the analysis 
• Study drug application 
− Apply study drug 
− Apply surgical tape 
• Assess, identify, and record any AEs 
 
• Record any concomitant medications 
 
• Provide subjects with take-home instructions describing how to remove the surgical 
tape, the possible LSR’s, and what to expect over the next 24 hours to several 
months. 
 
• Subjects will remove surgical tape and study drug at the designated removal time 
(2 hours (±1 hour), 6 hours (±2 hours), or 24 hours (±6 hours) after application 
− Removal of the surgical tape should be gentle and aided by soap and water, 
which will also help to prevent unroofing the blisters 
− Surgical tape should only be removed at the designated removal time, when the 
treatment site is washed and study drug removed 
− Surgical tape and study drug may be removed from individual warts before the 
designated removal time in the event of significant blistering, significant pain, 
or treatment-emergent AEs; surgical tape and study drug should not be removed 
from the remaining unproblematic warts until the designated removal time. 

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9.3.1.2 
Telephone Assessments at 24 hours (±6 hours), 7 days (±24 hours), and 14 days 
(±24 hours) after Study Drug Administration 
 
• ERT assessment 
− Only collect new information since the last contact 
− All ERT safety assessments must be conducted and recorded on ERT by a 
qualified member of the research team. 
 
• Assess, identify, and record any new AEs 
 
• Record any new concomitant medications 
 
9.3.1.3 
In-person Visit at 48 hours (±8 hours) after Study Drug Administration (Part A 
only) 
 
• Clinical assessments 
− Measure vital signs (temperature, heart rate) 
 
• ERT assessment 
− Only collect new information since the last contact 
− All ERT safety assessments must be conducted and recorded by a qualified 
member of the research team. 
 
• Assess, identify, and record any new AEs 
 
• Record any new concomitant medications 
 
9.3.2 
Treatment Periods 2, 3, 4 
 
The following evaluations will be performed and recorded in the eCRF. 
 
9.3.2.1 
Day 1 (Treatment Visit 2, Treatment Visit 3, Treatment Visit 4) 
 
• Clinical assessments 
− Measure vital signs (temperature, heart rate) before application of study drug 
• Wart assessments conducted before application of study drug 

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− Wart count conducted before dermatologic exam and ERT assessment 
 
• 
Conducted by a designated Blinded Assessor; Blinded Assessors are trained 
to the study and GCP, and listed on the FDA FORM 1572 and the site 
Delegation of Authority Log; the Blinded Assessor does not have to be the 
same person at each visit 
 
• 
Also conducted by a study team member who is not considered, or has not 
acted as, the Blinded Assessor for the subject throughout the subject’s 
participation 
 
− Wart anatomical location identified before dermatologic exam and ERT 
assessment 
 
• 
Conducted by a study team member who is not considered, or has not acted 
as, the Blinded Assessor for the subject throughout the subject’s 
participation 
 
• 
Warts that develop in areas that are unable to be treated, (e.g., close to a 
mucous membrane) will not be evaluated, documented, or considered in the 
analysis 
 
• Dermatologic exam by anatomical location 
 
− Conducted by a study team member who is not considered, or has not acted as, 
the Blinded Assessor for the subject throughout the subject’s participation 
 
• Laboratory assessments 
 
− Perform urine pregnancy test on female subjects of child-bearing potential (i.e., 
females who are capable of menstruating) before study drug application 
 
• ERT assessment conducted before study drug application 
 
− Only collect new information since the last contact 
 
− All ERT safety assessments must be conducted and recorded on ERT by a 
qualified member of the research team; ERT assessments must be conducted by 
a study team member who is not considered, or has not acted as, the Blinded 
Assessor for the subject throughout the subject’s participation 

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− Warts that develop in areas that are unable to be treated, (e.g., close to a mucous 
membrane) will not be evaluated, documented, or considered in the analysis 
 
• Photography conducted before study drug application 
 
− Subjects who previously agreed to participate in the photographic portion of the 
study will have photographs of warts taken by the study team, 
 
• Study drug application 
 
− Apply study drug 
 
− Apply surgical tape 
 
− Conducted by a study team member who is not considered, or has not acted as, 
the Blinded Assessor for the subject throughout the subject’s participation 
 
• Assess, identify, and record any new AEs 
 
• Record any new concomitant medications 
 
• Provide subjects with take-home instructions describing how to remove the surgical 
tape, the possible LSR’s, and what to expect over the next 24 hours to several 
months. 
 
• Subjects will remove surgical tape and study drug at the designated removal time 
(2 hours [±1 hour], 6 hours [±2 hours], or 24 hours [±6 hours]) after application 
 
− Removal of the surgical tape should be gentle and aided by soap and water, 
which will also help to prevent unroofing the blisters 
 
− Surgical tape should only be removed at the designated removal time, when the 
treatment site is washed and study drug removed 
 
− Surgical tape and study drug may be removed from individual warts before the 
designated removal time in the event of significant blistering, significant pain, 
or treatment-emergent AEs; surgical tape and study drug should not be removed 
from the remaining unproblematic warts until the designated removal time. 

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9.3.2.2 
Telephone Assessments at 24 hours (±6 hours), 7 days, and 14 days after Study 
Drug Administration 
 
• ERT assessment 
− Only collect new information since the last contact 
 
− All ERT safety assessments must be conducted and recorded on ERT by a 
qualified member of the research team; ERT assessments must be conducted by 
a study team member who is not considered, or has not acted as, the Blinded 
Assessor for the subject throughout the subject’s participation 
 
− Not required if there was no treatment during that treatment period 
 
• Assess, identify, and record any new AEs 
 
• Record any new concomitant medications 
 
9.4 
End-of-Treatment Visit: Study Day 84 (–0/+8 days) 
 
The following evaluations will be performed and recorded in the eCRF. 
 
• Clinical assessments 
− Conduct limited physical examination 
 
− Measure height and weight 
 
− Measure vital signs (temperature, heart rate) 
 
• Wart assessments 
 
− Wart count conducted before dermatologic exam and ERT assessments 
 
• 
Conducted by a designated Blinded Assessor; Blinded Assessors are trained 
to the study and GCP, and listed on the FDA FORM 1572 and the site 
Delegation of Authority Log; the Blinded Assessor does not have to be the 
same person at each visit 

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• 
Also conducted by a study team member who is not considered, or has not 
acted as, the Blinded Assessor for the subject throughout the subject’s 
participation 
 
− Wart anatomical location identified before dermatologic exam and ERT 
assessments 
 
• 
Conducted by a study team member who is not considered, or has not acted 
as, the Blinded Assessor for the subject throughout the subject’s 
participation 
 
• 
Warts that develop in areas that are unable to be treated, (e.g., close to a 
mucous membrane) will not be evaluated, documented, or considered in the 
analysis 
 
− Wart measurement (diameter and area) conducted before dermatologic exam 
and ERT assessments 
 
• 
Conducted by a study team member who is not considered, or has not acted 
as, the Blinded Assessor for the subject throughout the subject’s 
participation 
 
• Dermatologic exam by anatomical location 
 
− Conducted by a study team member who is not considered, or has not acted as, 
the Blinded Assessor for the subject throughout the subject’s participation 
 
• Laboratory assessments 
 
− Perform urine pregnancy test on female subjects of child-bearing potential (i.e., 
females who are capable of menstruating) 
 
• ERT assessment 
 
− Only collect new information since the last contact 
 
− All ERT safety assessments must be conducted and recorded on ERT by a 
qualified member of the research team; ERT assessments must be conducted by 
a study team member who is not considered, or has not acted as, the Blinded 
Assessor for the subject throughout the subject’s participation 

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− Warts that develop in areas that are unable to be treated, (e.g., close to a mucous 
membrane) will not be evaluated, documented, or considered in the analysis 
 
• Photography 
 
− Subjects who previously agreed to participate in the photographic portion of the 
study will have photographs of warts taken by the study team 
 
− If there are no warts remaining, the same areas will be photographed regardless 
of whether warts are present 
 
• Assess, identify, and record any new AEs 
 
• Record any new concomitant medications 
 
• Complete Provider questionnaire; by a clinician who applied treatment to the 
subject during the course of the study 
 
9.5 
Follow-up Visits on Study Day 112 (±7 days) and Study Day 147 (±7 days) (End- 
of-Study) 
 
Subjects will return to the clinical site and the following evaluations will be performed 
and recorded in the eCRF. 
 
• Clinical assessments 
 
− Measure height and weight 
 
− Measure vital signs (temperature, heart rate) 
 
• Wart assessments 
 
− Wart count conducted before dermatologic exam and ERT assessments 
 
• 
Conducted by a designated Blinded Assessor; Blinded Assessors are trained 
to the study and GCP, and listed on the FDA FORM 1572 and the site 
Delegation of Authority Log; the Blinded Assessor does not have to be the 
same person at each visit 

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• 
Also conducted by a study team member who is not considered, or has not 
acted as, the Blinded Assessor for the subject throughout the subject’s 
participation 
 
− Wart anatomical location identified before dermatologic exam and ERT 
assessments 
 
• 
Conducted by a study team member who is not considered, or has not acted 
as, the Blinded Assessor for the subject throughout the subject’s 
participation 
 
• 
Warts that develop in areas that are unable to be treated, (e.g., close to a 
mucous membrane) will not be evaluated, documented, or considered in the 
analysis 
 
− Wart measurement (diameter and area) conducted before dermatologic exam 
and ERT assessments 
 
• 
Conducted by a study team member who is not considered, or has not acted 
as, the Blinded Assessor for the subject throughout the subject’s 
participation 
 
• Dermatologic exam by anatomical location 
 
− Conducted by a study team member who is not considered, or has not acted as, 
the Blinded Assessor for the subject throughout the subject’s participation 
 
• Laboratory assessments 
 
− Perform urine pregnancy test on female subjects of child-bearing potential (i.e., 
females who are capable of menstruating) 
 
• ERT assessment 
 
− Only collect new information since the last contact 
 
− All ERT safety assessments must be conducted and recorded on ERT by a 
qualified member of the research team before study drug application; ERT 
assessments must be conducted by a study team member who is not considered, 

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or has not acted as, the Blinded Assessor for the subject throughout the subject’s 
participation 
 
− Warts that develop in areas that are unable to be treated, (e.g., close to a mucous 
membrane) will not be evaluated, documented, or considered in the analysis 
 
• Photography 
 
− Subjects who previously agreed to participate in the photographic portion of the 
study will have photographs of warts taken by the study team 
 
− If there are no warts remaining, the same areas will be photographed regardless 
of whether warts are present 
 
• Assess, identify, and record any new AEs 
 
• Record any new concomitant medications 
 
• Complete study completion form for all subjects (Study Day 147 (EOS) Visit only) 
 
9.6 
Unscheduled Visit 
 
In the event that any post-treatment LSR presents a safety concern (including but not 
limited to severe blistering, ulceration, edema, or pain), an “Unscheduled” clinic visit 
must be scheduled and the subject assessed accordingly. In addition, if any post-
treatment AEs present a safety concern, the subject may be brought in for an 
unscheduled visit. “Unscheduled” visits should also be used for visits in which 
treatment is unable to be applied to all warts due to ongoing LSRs. 
 
Subjects will return to the clinical site and the following evaluations will be performed 
and recorded in the eCRF. 
 
• Clinical assessments 
− Measure vital signs (temperature, heart rate) 
 
− Record reason why study drug was not administered at treatment visit (if 
applicable) 

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• Dermatologic exam by anatomical location 
 
− Conducted by a study team member who is not considered, or has not acted as, 
the Blinded Assessor for the subject throughout the subject’s participation 
 
• ERT assessment 
 
− Only collect new information since the last contact 
 
− All ERT safety assessments must be conducted and recorded on ERT by a 
qualified member of the research team before study drug application; ERT 
assessments must be conducted by a study team member who is not considered, 
or has not acted as, the Blinded Assessor for the subject throughout the subject’s 
participation 
 
− Warts that develop in areas that are unable to be treated, (e.g., close to a mucous 
membrane) will not be evaluated, documented, or considered in the analysis 
 
• Photography 
 
− Subjects who previously agreed to participate in the photographic portion of the 
study will have photographs of warts taken by the study team 
 
• Assess, identify, and record any new AEs 
 
• Record any new concomitant medications 
 
9.7 
Measurements and Evaluations 
 
9.7.1 
Skin Assessments 
 
• Dermatologic examination, including Fitzpatrick skin type 
 
• Wart count 
 
• Wart measurement (diameter) 
 
• Wart location by anatomical location. 

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9.7.2 
Identification of Skin Reactions 
 
An LSR guide for subjects with specific photographs identifying the various skin 
reactions and examples of intensity will be reviewed at the clinic with the subject by 
the research team. 
 
9.7.3 
Removal of Surgical tape 
 
Subjects are instructed to wet the treated area with water and then carefully and slowly 
remove the surgical tape from each wart, pulling the surgical tape back over itself in a 
low and slow manner, trying not to unroof any intact blisters. Treated warts should be 
gently washed with soap and water after the surgical tape is removed. The surgical tape 
and study drug may be gently removed from individual warts before the assigned 
duration of skin exposure in the event of significant blistering, significant pain, or 
TEAEs. The surgical tape and study drug should not be removed from any remaining 
unproblematic warts until the designated time point is reached. Washing of intact 
blisters should be gentle and without use of a washcloth. Washing and removal of 
surgical tape in a bath or shower is encouraged. For subjects participating in the photo 
portion of the study, photographs should be taken by the subject after the surgical tape 
and study drug are removed. 
 
9.7.4 
Evaluation of Response to Treatment Assessments 
 
An ERT assessment will be conducted at each treatment visit (1-4; in-person before 
treatment or via follow-up telephone calls) at 24 hours (±6 hours), 7 days (±24 hours), 
and 14 days (±24 hours) after each treatment visit (but not after “unscheduled” visits). 
Note that the ERT telephone calls at 24 hours (±6 hours), 7 days (±24 hours) and 
14 days (±24 hours) after treatment are not required if there was no treatment during 
that period. In Part A Treatment Period 1 only, subjects will return to the clinic for an 
in-person ERT assessment at 48 hours (±8 hours) after Treatment Visit 1. 
 
The ERT includes questions related to removal of surgical tape and study drug (if 
applicable) and collects any new AEs, LSRs, and changes in concomitant medications 
since the last contact. The subject will be given an opportunity to ask questions and 
review any concerns. 

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In the event that any AE presents a safety concern (including but not limited to severe 
blistering, ulceration, edema, or pain) an “Unscheduled” clinic visit may be scheduled 
and the subject assessed accordingly. 
 
The ERT assessments will be recorded by a research team member on the ERT form. 
The ERT visits may not be conducted by a person designated as a Blinded Assessor. 
Phone calls conducted outside of the required study visits or required ERT assessments 
should be documented in the subject’s source note but are not required to be entered in 
the EDC system. 
 
9.7.5 
Photographs of Lesions 
 
At designated sites, photography will be offered to volunteer subjects who consent to 
participate. Photography will take place at the clinical site at each treatment and 
follow-up study visit through Study Day 147 (±7 days) (EOS). If there are no warts 
remaining, the same areas will be photographed and repeated at the Study Day 84 (-
0/+8 days) EOT Visit and Study Day 147 (±7 days) EOS visit, regardless of whether 
warts are present. The images may be used on handouts in future trials, for training 
purposes, or future marketing materials. They will not be used for any portion of the 
efficacy or safety data. Photographs will be de-identified to those outside the research 
team and stored in a HIPAA-compliant manner. Efforts will be made to ensure that no 
photographs with identifiable features are obtained. 

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10.0 
ASSESSMENT OF SAFETY 
 
10.1 
Safety Parameters 
 
Safety analyses will include AEs, LSRs, medical history, physical examinations, vital 
signs, and concomitant medication use 
 
• The incidence of AEs will be assessed throughout the study; AEs will include all 
LSRs, whether or not they are expected or related to study drug mechanism of 
action. 
 
• LSRs of all previously treated areas will be assessed at each treatment visit using 
the protocol specific ERT form 
 
• Limited physical examinations will be completed before the first treatment and at 
the Study Day 147 (EOS) Visit; additional physical examinations will be performed 
when clinically warranted (e.g., subject reports symptoms classified as an AE 
requiring further evaluation) 
 
• Vital signs (temperature and heart rate) will be obtained before the treatment is 
applied at each treatment visit and at the start of the Study Day 84 (EOT) Visit 
 
• Concomitant medication use will be collected at each study visit and ERT telephone 
contact 
 
10.2 
Definitions 
 
10.2.1 
Adverse Event 
 
The following definition of AE will be used for this study: 
 
Adverse event means any untoward medical occurrence associated with the 
use of a drug in humans, whether or not considered drug related. 
 
An AE can be any unfavorable and unintended sign, symptom, or disease (new or 
exacerbated) temporally associated with the use of the investigational product, 
regardless of whether it is considered to be related to the investigational product. 

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The following are examples of AEs: 
 
• Exacerbation of a chronic or intermittent pre-existing condition, including an 
increase in frequency or intensity of the condition 
 
• New conditions detected or diagnosed after investigational product administration, 
even if they were present before the start of the study 
 
• Signs, symptoms, or the clinical sequelae of a suspected interaction with another 
medical product 
 
• Local skin reactions (erythema, scaling/flaking/dryness, edema/swelling, small 
blisters, hyper- and hypopigmentation, scabbing/crusting, erosion/ulcerations, 
scarring, ring warts) 
 
• Development of individual blisters that are > 25 mm in diameter (the diameter of a 
quarter); an aggregated blister composed of a number of smaller blisters is not 
considered a severe blister 
 
• Blistering distal to the treatment site 
 
• Scarring-independent of any pigmentary changes; include depressed (atrophic) and 
elevated (hypertrophic) 
 
• Secondary infection 
 
The following are NOT examples of AEs: 
 
• Medical procedures (The medical condition that led to the procedure as the AE 
should be reported.) 
 
• Situations that are unwanted by the subject but in which an untoward medical 
occurrence did not occur, for example social inconvenience after admission to a 
hospital 
 
• Anticipated day-to-day fluctuations of a pre-existing disease or condition (present 
or detected before enrollment) that does not worsen overall 

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• Expected progression of the disease being studied, including signs or symptoms of 
the disease, unless progression is more severe than expected for the subject’s 
condition. 
 
AEs may include pre-treatment or post-treatment events that occur as a result of 
protocol-mandated procedures (e.g., invasive procedures, modification of the subject’s 
previous therapeutic regimen). AEs should be captured even if they occur during 
periods without drug treatment or post-treatment periods. AE collection begins after 
the subject has signed informed consent and will continue until the EOS visit has been 
completed. 
 
The Investigator and study personnel will note all AEs mentioned by the subject 
starting from the day the informed consent is signed until the EOS visit (Study 
Day 147). All clinical complaints volunteered by or elicited from the subject during the 
study will be recorded on the appropriate page of the source and eCRF for the study 
period indicated. 
 
All unresolved AEs will be followed until the condition resolves and/or stabilizes, the 
subject is lost to follow-up or 30-days after the EOS visit, whichever comes first. All 
AEs will be summarized in the annual report or more frequently if requested by the 
regulatory agency. SAEs require special reporting in addition to documentation in the 
eCRF as described in Section 10.6. 
 
10.2.2 
Serious Adverse Event 
 
In this study, an SAE is defined as an AE that meets any of the following criteria: 
 
• Results in death 
 
• Is life-threatening 
 
− The term life-threatening in the definition of an SAE refers to an event in which 
the subject was at risk of death at the time of the event 
 
− The term life-threatening does not refer to an event that hypothetically might 
have caused death if it were more severe 

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• Requires hospitalization or a prolongation of an existing hospitalization 
 
− In general, hospitalization signifies that the subject has been detained at the 
hospital or emergency ward for observation or treatment that would not have 
been appropriate in the physician’s office or out-patient setting. 
 
− Complications that occur during hospitalization are AEs, but not necessarily 
SAEs. 
 
− An occurrence or complication that prolongs hospitalization is an SAE. When 
there is doubt as to whether hospitalization occurred or was necessary, the AE 
should be considered an SAE. 
 
− Hospitalization for elective treatments of a preexisting condition that did not 
worsen from its original baseline level is not considered an SAE. 
 
• A persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions 
 
− This definition is not intended to include AEs of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza and accidental trauma (e.g., sprained ankle) that may interfere or 
prevent everyday life functions but do not constitute a substantial disruption. 
 
• Another important medical event 
 
− Medical or scientific judgment should be exercised when deciding whether 
reporting is appropriate for other important medical events that may not result 
in death, be life-threatening, or require hospitalization but still may jeopardize 
the subject or may require medical intervention to prevent one of the outcomes 
listed in this definition. 
− These events should also be considered serious. 
 
− Examples of such events are intensive treatment in an emergency room or at 
home for allergic bronchospasm, blood dyscrasias, or convulsions that do not 
result in hospitalization. 

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An SAE requires additional detailed reports and follow-up. The content of these 
detailed reports must address the Investigator’s estimate of causality. The Medical 
Monitor will review the SAE to determine if it is an expected SAE (i.e., whether or not 
the SAE is identified in nature, severity, and frequency in the VP-102 IB). 
 
10.2.3 
Expectedness of Serious Adverse Events 
 
An expected AE is one that is consistent with the known risk information described in 
the product label (if applicable) or the current IB. The expectedness of an SAE will be 
assessed by the Medical Monitor or Sponsor on receipt of the initial SAE report. 
 
10.3 
Assessment of Intensity 
 
The Investigator will assess the intensity for each AE and SAE reported during the 
study. The assessment will be based on the Investigator’s clinical judgment. 
 
The classifications in Table 4 should be used in assigning intensity of each AE recorded 
in the eCRF. 
 
Table 4. 
Classification of Adverse Events by Intensity 
Intensity 
Definition 
Mild AE 
An event that is easily tolerated by the subject, causing minimal discomfort and not interfering 
with everyday activities 
Moderate AE 
An event that is sufficiently discomforting to the extent of interfering with normal everyday 
activities 
Severe AE 
An event that prevents the subject from performing normal everyday activities 
AE: adverse event. 
 
 
Any AE that changes in intensity during its course will be recorded in the eCRF at the 
highest level experienced by the subject. 
 
An AE that is assessed as severe should not be confused with an SAE. Severity is a 
category used for rating the intensity of an AE (such as mild, moderate, or severe 
myocardial infarction). However, the event itself may be of relatively minor medical 
significance, such as a severe headache. Both AEs and SAEs can be assessed as severe. 
An AE is considered serious (an SAE) when it meets one of the predefined outcomes 
described in Section 10.2.2. 

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Local Skin Reactions should be rated based on the severity ratings in the Local Skin 
Reaction Guide that is provided. 
 
10.4 
Assessment of Causality 
 
The Investigator must estimate the relationship between the investigational product and 
the occurrence of each AE or SAE by using his or her best clinical judgment. Elements 
to consider for this estimate include the history of the underlying disease, concomitant 
therapy, other risk factors, and the temporal relationship of the event to the 
investigational product. The Investigator will also consult the IB or product label for 
marketed products in estimating the relationship. 
 
Because of reporting timelines, the Investigator might have minimal information to 
include in the initial SAE report. However, the Investigator must always make an 
assessment of causality for every SAE before the transmission of the SAE report. The 
Investigator may change his or her opinion of the causality in light of follow-up 
information, with subsequent amendment of the SAE report. Causality assessment is 
one of the criteria used to determine regulatory reporting requirements and should not 
be left blank in the SAE report. The same applies to AEs that are to be processed as 
SAEs. Some definitions to use in the assessment are provided in Table 5. 
 
Table 5. 
Assessment of Causality of AEs 
Term 
Definition 
Definitely related 
The AE is clearly related to the investigational agent(s) or research intervention: the 
AE has a temporal relationship to the administration of the investigational agent(s) 
or research intervention and follows a known pattern of response, and no alternative 
cause is present. 
Possibly related 
The AE may be related to the investigational agent(s) or intervention: the AE has a 
temporal relationship to the administration of the investigational agent(s) or research 
intervention and follows a suspected pattern of response, but an alternative cause is 
present. 
Probably related 
The AE is likely related to the investigational agent(s) or intervention: the AE has a 
temporal relationship to the administration of the investigational agent(s) or research 
intervention and follows a known or suspected pattern of response, but an 
alternative cause may be present. 
Unrelated 
(or not related) 
The AE is clearly not related to the investigational agent(s) or intervention: the AE 
has no temporal relationship to the administration of the investigational agent(s) or 
research intervention, and follows no known or suspected pattern of response, and 
an alternative cause is present. 
AE: adverse event. 

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10.5 
Recording Adverse Events and Serious Adverse Events 
 
When an AE or SAE occurs, the Investigator is responsible for reviewing all 
documentation (e.g., hospital progress notes, laboratory, and diagnostic reports) 
relative to the event(s). The Investigator will record all relevant information about any 
AE (including SAEs) on the AE page of the eCRF. It is not acceptable for the 
Investigator to send photocopies of the subject’s medical records in lieu of the properly 
completed AE or SAE pages of the eCRF. These documents should not be sent unless 
they are specifically requested by the designated Medical Monitor. If this request 
occurs, all subject identifiers and protected health information should be blinded on the 
copies of the medical records before submission to the Sponsor and to the appropriate 
authorities. 
 
The Investigator will also attempt to report a diagnosis, instead of signs, symptoms, or 
other clinical information, for the AE. The diagnosis, not the individual signs and 
symptoms, should be documented on the appropriate page of the eCRF as the AE or 
SAE. In addition, SAEs need to be reported in the SAE report. AEs being processed as 
SAEs will also require additional documentation. 
 
10.6 
Reporting of Serious Adverse Events 
 
Any SAE occurring after the subject signs the ICF must be reported to the Sponsor or 
designee within 24 hours of the time the Investigator becomes aware of the SAE 
(Table 6). 
 
Table 6.          Timeline for Reporting of Serious Adverse Events 
Initial SAE Report 
Follow-up SAE Report 
Time Frame 
Documents 
Time Frame 
Documents 
24 hours 
SAE report 
7 days 
Updated SAE report 
SAE: serious adverse event. 
 
 
Urgent reporting of SAEs is required for the following reasons: 
 
• To enable the Sponsor to fulfill the reporting requirements to the appropriate 
regulatory authority 
 
• To facilitate discussion between the Sponsor and the Investigator about appropriate 
follow-up measures (if necessary) 

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• To facilitate the Sponsor’s rapid dissemination of information about AEs to other 
Investigators or sites in a multicenter study 
 
• To facilitate reporting unanticipated problems involving risk to subjects to the IRB. 
The SAE report must be completed as thoroughly as possible, including the following: 
• Subject identification information 
 
• Event term 
 
• All available details about the SAE 
 
• Causality of each SAE 
 
• Signature of the Investigator 
 
Within 24 hours of awareness of a new SAE, the investigative site will call the Paidion 
Research Medical Monitor (xxxxx) by calling the SAE Hotline at xxxxx. The SAE 
Hotline may be accessed and is monitored 24 hours/day, 7 days/week. The 
investigative site must also initiate entry of the SAE report form into the EDC system 
being used for this study. The SAE report should include the essential elements. 
 
The SAE report will be forwarded to the Sponsor within the designated time frames. If 
additional information to complete the SAE report form is needed, the Investigator will 
not wait before notifying the Paidion Medical Monitor of the SAE via the SAE Hotline. 
The SAE report form will be updated by the Investigator when additional information 
is received. 
 
10.7 
Follow-up of Adverse Events and Serious Adverse Events 
 
After the initial AE or SAE report, the Investigator is required to follow each subject 
until the occurrence of one of the following: 
 
• The condition resolves and/or stabilizes 
 
• The subject is lost to follow-up 
 
• 30-days after the EOS visit 

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The appropriate SAE report form will be updated in the EDC after the SAE resolves, 
stabilizes, or is otherwise explained or until the subject is lost to follow-up. The 
Investigator will also ensure that updates include any supplemental data that may 
explain causality of the SAE(s). 
 
10.8 
Risks for Women of Child-bearing Potential or During Pregnancy 
 
The risks of VP-102 application during pregnancy have not been evaluated. Pregnant 
or lactating females who are nursing are excluded from this study. 
 
Female and male subjects must be instructed to inform the Investigator immediately if 
they become pregnant or genetically contribute to a pregnancy during the study. Should 
study personnel become aware of a subject’s (or subject’s partner’s) pregnancy, the site 
personnel must report the pregnancy to the Sponsor’s Medical Monitor within 24 hours 
by using the pregnancy notification form. The female subject will discontinue study 
drug. The pregnancy will be followed until the outcome is known and will be reported 
to the Sponsor. 
 
Pregnancy is not an AE, in and of itself. However, any pregnancy complication or 
elective termination of a pregnancy for medical reasons will be recorded as an AE or 
SAE. A spontaneous abortion is always considered an SAE and will be reported as 
described in the AE and SAE sections. Furthermore, any SAE occurring as an adverse 
pregnancy outcome post-study must be reported to the Medical Monitor. 
 
10.9 
Special Safety Considerations 
 
• Investigators should confirm that study drug is completely dry (2-5 minutes) before 
applying the surgical tape or allowing the treated areas to come into contact with 
healthy skin, clothing, furniture, or other surface areas. 
 
− In addition, an adhesive bandage may be applied over the surgical tape to keep 
it in place on areas that have a high probability of transference to healthy skin, 
mucous membranes, or that may experience significant flexing as in a skin fold. 
 
• VP-102 is considered highly flammable, even after drying. Subjects should avoid 
fire, flame, or smoking until study drug has been removed from the skin. 

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• Cantharidin has been shown to be safe for topical use, but is highly toxic if ingested. 
To deter potential oral ingestion, a bitter compound has been added to the study 
drug. 
 
• Subjects should refrain from sexual activity involving the treated area as well as 
touching, licking, or biting treated skin or putting treated skin in or near any 
mucosal surface including the mouth, nostrils, eyes, and anogenital area for at least 
48 hours after treatment or until the study drug is removed. 
 
• Subjects are encouraged to wash their hands regularly with soap and water (being 
mindful to keep treated areas on the hands dry) and discouraged from scratching or 
picking at warts, which can spread disease 

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11.0 
ASSESSMENT OF EFFICACY 
 
11.1 
Efficacy Parameters 
 
Efficacy parameters will be recorded for all enrolled subjects in the Intent-to-Treat 
(ITT) and PP Populations by randomization group. Clinical response to treatment will 
be evaluated at each scheduled visit until EOS by counting all treatable warts. Genital 
warts that develop in areas that are unable to be treated, (e.g., close to a mucous 
membrane) and other wart types (e.g., common warts) will not be evaluated, 
documented, or considered in the analysis. 
 
Primary Efficacy Endpoint: 
 
• Proportion of subjects exhibiting complete clearance of all treatable warts at the 
Study Day 84 (EOT) Visit 
 
Secondary Efficacy Endpoints: 
 
• Proportion of subjects exhibiting complete clearance of all treatable warts (baseline 
and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up 
Visits on Study Day 112 and Study Day 147 (EOS) 
 
• Proportion of subjects exhibiting 90% and 75% clearance of all treatable warts 
(baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study 
Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) 
 
• Change from baseline in the number of treatable warts (baseline and new) at 
Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and 
Follow-up Visits on Study Day 112 and Study Day 147 (EOS) 
 
• Change from baseline in the percent of treatable warts (baseline and new) at 
Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), 
and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) 
 
Exploratory Efficacy Endpoints: 
 
• Proportion of subjects exhibiting reduction of ≥ 1 treatable wart from baseline at 
Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and 
Follow-up Visits on Study Day 112 and Study Day 147 (EOS) 

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• Proportion of subjects who are clear at the Study Day 84 (EOT) Visit and remain 
clear at the Follow-up Visits on Study Day 112 and Study Day 147 (EOS) 
 
• Change from baseline in total wart area (sum of individual warts) at Study Day 84 
(EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) 
 
• Change from baseline in the percent of total wart area (sum of individual warts) at 
Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 
(EOS) 

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12.0 
STATISTICAL METHODS 
 
Subject disposition, demographics, baseline characteristics, and study drug exposure 
will be summarized. The data will be summarized in tables, as appropriate, showing 
the number of subjects with non-missing data (n), mean, standard deviation, median, 
minimum, and maximum for continuous data and showing counts and percentage for 
categorical data. Data will also be listed as deemed appropriate. 
 
Summaries of data from subjects enrolled in Part A will be pooled with corresponding 
subjects in Part B. For instance, if one of the two regimens selected for Part B is the 6- 
hour application of VP-102, then results from subjects who received the 6-hour 
application of VP-102 from Part A will be pooled with results from subjects who 
received the 6-hour application of VP-102 from Part B. 
 
An additional set of tables will be generated that summarize subjects from Part A of 
the study who are not used in Part B of the study. Summary statistics for continuous 
variables and counts and percentages for categorial variables will be shown by 
treatment. However, due to the limited number of subjects for this set of tables 
(expected n=6), analyses to be carried out will only be descriptive in nature. 
 
12.1 
Analysis Populations 
 
• The Intent-to-Treat (ITT) Population will include all randomized subjects 
 
• The Safety Population will include all randomized subjects who receive 
≥ 1 application of study drug (VP-102 or placebo) 
 
• The Per-Protocol (PP) Population will include all subjects who receive all planned 
treatments of study drug (e.g., complete up to four treatments within the Day 75 
treatment window or clear before Day 75), had no major protocol violations, and 
were assessed for clearance at the Study Day 84 (–0/+8 days) EOT Visit 
 
12.2 
Analysis of Study Population and Subject Characteristics 
 
Subject demographics, efficacy tables, and subject dropout rates will be tabulated at 
the Study Day 84 (EOT) Visit and the Study Day 147 (EOS) Visit. Data will be 
summarized using descriptive statistics (sample size, mean, median, standard 
deviation, minimum, maximum) for continuous variables and frequencies, and 

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percentages for discrete variables. Corresponding by-subject data listings will be 
tabulated. 
 
12.3 
Efficacy Analyses 
 
Efficacy will be evaluated in the ITT and PP Populations by treatment group. 
 
At the end of the study, Part B tables will be generated that pool subjects from Part A 
and Part B. The regimens included in these tables will be VP-102 Regimen 1, VP-102 
Regimen 2, Placebo Regimen 1, and Placebo Regimen 2 (Section 6.1.2). For the 
efficacy endpoints (Section 11.1), summary statistics for continuous variables and 
counts and percentages for categorical variables will be presented. In addition, 
statistical comparisons will be carried out to compare VP-102 Regimen 1 to Placebo 
Regimen 1 and VP-102 Regimen 2 to Placebo Regimen 2. Comparisons made within 
Regimen 1 (VP-102 vs Placebo) will be independent of comparisons made within 
Regimen 2. Comparisons may be carried across Regimens; however, no formal 
statistical testing will be carried out with comparisons being considered only 
observational. 
 
An additional set of tables will be generated that summarize subjects from Part A of 
the study who are not used in Part B of the study. Summary statistics for continuous 
variables and counts and percentages for categorial variables will be shown by 
treatment. However, due to the limited number of subjects for this set of tables 
(expected n=6), analyses to be carried out will only be descriptive in nature. 
 
12.4 
Safety Analyses 
 
Safety analyses will be conducted in the Safety Population by actual treatment received. 
 
Adverse events, including LSRs, will be coded with the Medical Dictionary for 
Regulatory Activities (MedDRA®) Version 20.0. The number and percentage of 
subjects having TEAEs will be tabulated by system organ class and MedDRA preferred 
term with a breakdown by treatment group. A subject-by-subject AEs data listing, 
including verbatim term, preferred term, treatment, severity, location, and causal 
relationship to the study drug will be provided. The number of subjects experiencing 
TEAEs and number of TEAEs will be summarized by treatment using frequency 
counts. 

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Any AE with an onset date after the EOS visit will be considered off study and will not 
be included in tables summaries (although they will appear in AE listings). Each AE 
will be counted only once for a given subject. If the same AE occurs on multiple 
occasions for a subject, the occurrence with the highest severity and relationship to 
study drug will be reported. If two or more AEs are reported as a unit, the individual 
terms will be reported as separate events. 
 
Changes in vital signs (temperature and heart rate), from baseline to EOS, will be 
examined. Treatment-emergent changes from normal values to abnormal values will 
be identified. 
 
12.5 
Interim Analysis 
 
No interim analysis is planned for this study. 
 
12.6 
Determination of Study Sample Size 
 
Although no formal power calculations have been performed, it is expected that a 
sample size of 18 subjects in Part A and 90 subjects in Part B, evaluable at the Study 
Day 84 (–0/+8 days) EOT Visit, will be informative regarding wart clearance rates that 
can support assumptions in subsequent placebo-controlled trials. 
 
12.7 
Handling of Missing, Unused, and Spurious Data 
 
Subjects who do not have an assessment of complete clearance of all treatable warts at 
the EOS visit (Study Day 84) will be considered to have missing data for the primary 
endpoint. The primary method to handle missing data will be to assign all subjects with 
missing complete clearance data as not having achieved complete clearance. 
 
In the event a subject requests to be removed from the study due to study-related 
adverse experiences or additional spreading of disease, data will be collected and 
analyzed as a treatment failure and the subject may be replaced. Further discussion of 
how treatment failure will be utilized in analysis will be provided in the Statistical 
Analysis Plan. 
 
The procedures for handling missing data for other study endpoints will be described 
in the Statistical Analysis Plan. 

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12.8 
Termination Criteria 
 
Enrollment and withdrawals from the study and from study drug will be summarized 
by dose level. 
 
12.9 
Deviation Reporting 
 
Protocol deviations are defined as any variation from the protocol, including enrollment 
of a subject who did not meet all inclusion and exclusion criteria and failure to perform 
the assessments and procedures within the required time frame. 

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13.0 
PROTECTION OF HUMAN SUBJECTS 
 
This study will be conducted in compliance with the ICH Technical Requirements for 
Registration of Pharmaceuticals for Human Use E6 GCP: Consolidated Guidelines, the 
ethical principles of the Declaration of Helsinki, the National Health and Medical 
Research Council Statement on Ethical Conduct in Human Research (2007, 
incorporating all updates as of July 2018), FDA GCP guidelines, and any additional 
national or Human Research Ethics Committee required procedures. 
 
The ICF and authorization for use and disclosure of protected health information, which 
is prepared by the Investigator or the site, must have been reviewed and approved by 
the Sponsor, the Study Monitor, and the Investigator’s IRB and privacy board (if 
separate from the IRB) before the initiation of the study. The ICF must contain the 
20 elements of informed consent described in ICH E6, Section 4.8. The authorization 
for use and disclosure of protected health information must contain the elements 
required by Title 45 of the Code of Federal Regulations, Section 164.508(b), and any 
local regulations for valid authorizations. 
 
Subjects will give written consent to participate in the study at the first visit, prior to 
initiation of any study-related procedures, after having been informed about the nature 
and purpose of the study, participation and termination conditions, risks, and benefits. 
If applicable, it will be provided in certified translation for non-English-speaking 
subjects. 
 
Written informed consent and authorization of use and disclosure of protected health 
information must be obtained from each subject before performing any study-specific 
screening/baseline period evaluations. One copy of the signed ICF and Authorization 
for Use and Disclosure of Protected Health Information form will be given to the 
subject, and the Investigator will retain the original. Signed consent forms must remain 
in the subject’s study file and be available for verification by Sponsor at any time. 

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14.0 
INVESTIGATOR REQUIREMENTS 
 
14.1 
Investigator Information 
 
Investigator information is included in the Investigator’s Brochure, which is updated 
as needed. 
 
14.2 
Investigator’s Study Files 
 
Documentation about the Investigator and study staff, the IRB, and the institution is 
required before site initiation. Copies of these documents will be kept on-site in site-
specific binders or electronic folders, along with the following supplemental 
information: a list of Investigator’s obligations, the IB, the clinical protocol and 
amendments, safety information, information about investigational product, the study 
logs, eCRFs, records of monitoring activities, and correspondence between Sponsor or 
Study Monitor and the Investigator. Audit trails are generated automatically for eCRFs. 
The Investigator is responsible for maintaining audit trails of all electronic data systems 
used for source documentation. 
 
14.3 
Electronic Case Report Forms and Source Documentation 
 
The Investigator must make study data accessible to the Site Monitor, other authorized 
representatives of the Sponsor, and the appropriate regulatory authority inspectors. The 
eCRF for each subject will be checked against source documents at the site by the Site 
Monitor, and a final copy of the eCRF will be signed by the Investigator with an 
electronic signature and includes an attestation they have reviewed and attest to the 
accuracy of all data recorded in the EDC and any supporting documentation. A copy 
of the final eCRFs will be provided to the Investigator in PDF on computer disc after 
study closure, to be kept in the Investigator’s study files. 
 
14.4 
Retention of Study Documents 
 
According to ICH E6 guidance, all eCRFs, as well as supporting paper and electronic 
source documentation and administrative records, must be retained by the Investigator 
until at least 2 years following notification that either the appropriate regulatory 
authority has approved the product for the indication under study, the Sponsor has 

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discontinued clinical development of the product, or notification that the marketing 
application was not approved. 
 
These documents should be retained for a longer period, however, if required by the 
applicable regulatory requirements or by an agreement with the Sponsor. The Sponsor 
is responsible for informing the Investigator and institution as to when these documents 
no longer need to be retained. No study documents will be destroyed or moved to a 
new location without prior written approval from the Sponsor. If the Investigator 
relocates, retires, or withdraws from the study for any reason, all records required to be 
maintained for the study should be transferred to an agreed-upon designee, such as 
another Investigator at the institution where the study was conducted. 
 
Audit trails for electronic document must be retained for a period at least as long as the 
period required for the subject’s electronic records to which they pertain. The 
Investigator must retain either the original of the audit trails or a certified copy of the 
audit trails. 
 
14.5 
Confidentiality 
 
14.5.1 
Data 
 
The Investigator must keep all information confidential about the nature of the 
proposed investigation provided by the Sponsor or Study Monitor to the Investigator 
(with the exception of information required by law or regulations to be disclosed to the 
IRB, the subject, or the appropriate regulatory authority). 
 
14.5.2 
Subject Anonymity 
 
The anonymity of participating subjects must be maintained. Subjects will be identified 
by an assigned subject number on eCRFs and other documents retrieved from the site 
or sent to the Study Monitor, Sponsor, regulatory agencies, analysis laboratories, or 
blinded reviewers. Documents that identify the subject (e.g., the signed ICF) must be 
maintained in strict confidence by the Investigator, except to the extent necessary to 
allow auditing by the appropriate regulatory authority, the Study Monitor, or Sponsor 
representatives. 

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14.6 
Protocol Compliance 
 
Substantive changes in the protocol include changes that affect the safety of subjects 
or changes that alter the scope of the investigation, the scientific quality of the study, 
the experimental design, dosages, assessment variable(s), the number of subjects 
treated, or the subject-selection criteria. Such changes must be prepared as a protocol 
amendment by the Sponsor and implemented only upon joint approval of the Sponsor 
and the Investigator. A protocol amendment must receive IRB approval before 
implementation. In parallel with the IRB approval process, the protocol amendment 
will be submitted to the appropriate regulatory authority as an amendment to the 
regulatory submission under which the study is being conducted. If a protocol 
amendment requires changes in the ICF, the revised informed consent form prepared 
by the Investigator must also be approved by the Sponsor, Study Monitor, and the IRB 
before implementation. 
 
In instances where there is an immediate risk to a subject that is deemed crucial for the 
safety and well-being of that subject, the Investigator or the attending physician will 
contact the Medical Monitor as soon as possible to make them aware of such a 
departure. These departures do not require preapproval by the IRB; however, the IRB 
and Medical Monitor must be notified in writing as soon as possible after the departure 
has been made. In addition, the Investigator will document the reasons for the protocol 
deviation and the ensuing events in the subject’s eCRF. 
 
14.7 
Study Monitor Functions and Responsibility 
 
The Study Monitor, in accordance with the Sponsor’s requirements, will ensure that 
the study is conducted and documented properly by carrying out the activities outlined 
in ICH E6 guidance. 
 
14.8 
General Information 
 
The Investigator should refer to the IB, Instructions For Use, and any other information 
provided about this investigational product and details of the procedures to be followed 
during this study. 

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15.0 
DATA HANDLING AND RECORD KEEPING 
 
The Investigator is required to prepare and maintain adequate and accurate source 
documents designed to record all observations and other data pertinent to the study for 
each study subject. Electronic case report forms (eCRFs) will be used to capture study 
assessments and data. The study coordinator or other delegated study personnel will 
enter data from source documents into the eCRFs. All eCRFs will be reviewed and 
source-verified by the Study Monitor during periodic site visits as well as via 
centralized monitoring, and the Study Monitor will ensure that all data in the eCRF are 
correct and complete. All information recorded on the eCRFs for this study must be 
consistent with the source documentation (i.e., medical records). Before or between 
visits, the Medical Monitor or Study Monitor may conduct a preliminary medical 
review of the eCRFs. After the eCRFs are completed and source-verified, the 
Investigator must electronically sign all required pages in the eCRF, verifying the 
accuracy of all data contained in the eCRF. 
 
Training will be provided for the EDC system. All study personnel using the EDC 
system must have the necessary education, training, and experience or any combination 
of these. The Investigator will be responsible for documenting employee education, 
training, and previous experience that pertain to the EDC system for all site personnel 
using the EDC system. 
 
The Investigator must maintain adequate security of the EDC system, including 
documentation that all users have been trained on the appropriate SOP and a list of 
authorized users. To ensure all data entries can be tracked, all personnel responsible for 
data entry must obtain a unique user identification and password before any data can 
be entered in the eCRFs. Authorized study personnel will be assigned a unique user 
identification only after receiving SOP training. 
 
If electronic data systems other than those provided and maintained by the Sponsor are 
used for documentation and data capture, the Investigator must ensure that the systems 
are validated and that data are backed up as described in Section 14.0. 

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16.0 
QUALITY CONTROL AND QUALITY ASSURANCE 
 
Written SOPs will be followed to ensure that the study is conducted and data are 
generated, documented (recorded), and reported in compliance with the protocol, GCP, 
and the applicable regulatory requirements. Quality control will be applied to each 
stage of data handling. Regular monitoring, as defined in ICH GCP, Section 1.8, “The 
act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, 
recorded, and reported in accordance with the protocol, SOPs, GCP, and the applicable 
regulatory requirement(s)”, will be conducted throughout the conduct of the study. 
 
The purpose of monitoring is to verify that: 
 
• Rights and well-being of the human subjects are protected 
 
• The reported study data are accurate, complete, and verifiable from source 
documents 
 
• The conduct of the study is in compliance with the currently approved 
protocol/amendment(s), with GCP, and with the applicable regulatory requirements 
 
• Monitoring is an integral role in the quality control of a clinical trial and is designed 
to verify the quality of the study 
 
To fulfill the Quality Assurance requirements of GCP, audits will be conducted to 
assess and assure the reliability and integrity of a study’s quality control systems and 
recognized standards. 
 
The purpose of an audit is to: 
 
• Ensure participant safety 
 
• Assure compliance to study protocol procedures, regulatory requirements, and 
SOPs 
 
• Assure data quality 

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17.0 
FINANCING AND INSURANCE 
 
The financing and insurance for this study are outlined in the Clinical Trial Agreement. 

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18.0 
PUBLICATION POLICY 
 
The data generated in this clinical study are the exclusive property of the Sponsor and 
are confidential. Authorship on any publication of the results from this study will be 
based on contributions to study design, enrollment, data analysis, and interpretation of 
results. 

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19.0 
REFERENCES 
 
1. 
Recanati MA, Kramer KJ, Maggio JJ, Chao CR. Cantharidin is Superior to 
Trichloroacetic Acid for the Treatment of Non-mucosal Genital Warts: A Pilot 
Randomized Controlled Trial. Clin Exp Obstet Gynecol. 2018;45(3):383-386. 
 
2. 
Juckett G, Hartman-Adams H. Human papillomavirus: clinical manifestations 
and prevention. Am Fam Physician. 2010;82(10):1209-1213. 
 
3. 
Centers for Disease Control and Prevention. Sexually Transmitted Diseases 
Treatment Guidelines. 2015; Accessed February 8, 2019 Available at: 
https://www.cdc.gov/std/tg2015/warts.htm. 
 
4. 
Satterwhite CL, Torrone E, Meites E, Dunne EF, Mahajan R, Ocfemia MC, 
et al. Sexually transmitted infections among US women and men: prevalence 
and incidence estimates, 2008. Sex Transm Dis. 2013;40(3):187-193. 
 
5. 
Centers for Disease Control and Prevention. Genital HPV Infection Fact Sheet. 
Accessed February 8, 2019 Available at: https://www.cdc.gov/std/hpv/stdfact- 
hpv.htm. 
 
6. 
Chelimo C, Wouldes TA, Cameron LD, Elwood JM. Risk factors for and 
prevention of human papillomaviruses (HPV), genital warts and cervical 
cancer. J Infect. 2013;66(3):207-217. 
 
7. 
Epstein WL, Kligman AM. Treatment of warts with cantharidin. AMA Arch 
Derm. 1958;77(5):508-511. 
 
8. 
Bertaux B, Prost C, Heslan M, Dubertret L. Cantharide acantholysis: 
endogenous protease activation leading to desmosomal plaque dissolution. Br J 
Dermatol. 1988;118(2):157-165. 
 
9. 
Ivetic Tkalcevic V, Hrvacic B, Bosnar M, Cuzic S, Bosnjak B, Erakovic Haber 
V, et al. Cantharidin-induced inflammation in mouse ear model for translational 
research of novel anti-inflammatories. Transl Res. 2012;160(2):137-145. 

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10. 
Li YM, Casida JE. Cantharidin-binding protein: identification as protein 
phosphatase 2A. Proc Natl Acad Sci U S A. 1992;89(24):11867-11870. 
 
11. 
Qualls HJ, Holbrook TC, Gilliam LL, Njaa BL, Panciera RJ, Pope CN, et al. 
Evaluation of efficacy of mineral oil, charcoal, and smectite in a rat model of 
equine cantharidin toxicosis. J Vet Intern Med. 2013;27(5):1179-1184. 
 
12. 
Knapp J, Boknik P, Linck B, Luss H, Muller FU, Nacke P, et al. The effect of 
the protein phosphatases inhibitor cantharidin on beta-adrenoceptor-mediated 
vasorelaxation. Br J Pharmacol. 1997;120(3):421-428. 
 
13. 
Dang YJ, Zhu CY. Oral bioavailability of cantharidin-loaded solid lipid 
nanoparticles. Chin Med. 2013;8(1):1. 
 
14. 
Dang Y, Zhu C. Pharmacokinetics and bioavailability of cantharidin in beagle 
dogs. Zhongguo Zhong Yao Za Zhi. 2009;34(16):2088-2091. 
 
15. 
Guzman AK, Schairer DO, Garelik JL, Cohen SR. Safety and efficacy of topical 
cantharidin for the treatment of pediatric molluscum contagiosum: a 
prospective, randomized, double-blind, placebo-controlled pilot trial. Int J 
Dermatol. 2018;57:1001-1006. 
 
16. 
Code of Federal Regulations (annual edition). Title 40: Protection of 
Environment. Part 355: EMERGENCY PLANNING AND NOTIFICATION. 
Sunday, July 1, 2018. Sunday, July 1, 2018; Accessed March 6, 2019 Available 
at: 
https://www.govinfo.gov/content/pkg/CFR-2018-title40-vol30/pdf/CFR- 
2018-title40-vol30-part355-appA.pdf. 
 
17. 
Moed L, Shwayder TA, Chang MW. Cantharidin revisited: a blistering defense 
of an ancient medicine. Arch Dermatol. 2001;137(10):1357-1360. 
 
18. 
Cathcart S, Coloe J, Morrell DS. Parental satisfaction, efficacy, and adverse 
events in 54 patients treated with cantharidin for molluscum contagiosum 
infection. Clin Pediatr (Phila). 2009;48(2):161-165. 

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19. 
Jahnke MD. Cantharidin on the Face? Yes, it is Safe! A Retrospective Case 
Series on the Treatment of Pediatric Facial Molluscum Contagiosum. Pediatr 
Dermatol. 2015;32:756. 
 
20. 
Moye VA, Cathcart S, Morrell DS. Safety of cantharidin: a retrospective review 
of cantharidin treatment in 405 children with molluscum contagiosum. Pediatr 
Dermatol. 2014;31(4):450-454. 
 
21. 
Silverberg NB, Sidbury R, Mancini AJ. Childhood molluscum contagiosum: 
experience with cantharidin therapy in 300 patients. J Am Acad Dermatol. 
2000;43(3):503-507. 
 
22. 
Epstein JH, Epstein WL. Cantharidin treatment of digital and periungual warts. 
Calif Med. 1960;93:11-12. 
 
23. 
Rosenberg EW, Amonette RA, Gardner JH. Cantharidin treatment of warts at 
home. Arch Dermatol. 1977;113(8):1134. 
 
24. 
Panzer HM. Cantharidin--a useful agent in the local treatment of warts. J 
Germantown Hosp. 1961;2:82-86. 

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APPENDICES 

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Appendix 1: Version History and Summary of Changes 
 
SUMMARY OF PROTOCOL CHANGES: VP-102-104 
 
Version history: 
 
DOCUMENT 
VERSION 
DATE 
Protocol VP-102-104 
1 
09 May 2019 
Protocol VP-102-104 
2 
07 August 2019 
 
SECTIONS/PAGES CHANGED 
DESCRIPTION OF CHANGES 
Administrative Update Throughout Protocol 
Updated Version to 2.0 and updated version date 
to 07 August 2019. 
Title of Study (pg. 1) 
Protocol Synopsis: Title of Study (pg. 4) 
The study title was updated to include 
“Cantharidin” and the study acronym of CARE-1 
was added. CARE stands for CAntharidin 
Regimen in External Genital Warts. 
Protocol Synopsis: Objectives (pg. 4) 
Section 5: Study Purpose and Objectives (pg. 41) 
Added clarification that secondary and 
exploratory objectives will be applicable to both 
Part A and Part B of the study. 
Protocol Synopsis: Exploratory Objectives (pg. 5) 
Section 5: Study Purpose and Objectives (pg. 41) 
The change from baseline in total wart area and 
the percent change from baseline in total wart area 
were added as two new exploratory objectives. 
Removed reference to “Part B Only” as these will 
be applicable to both parts of the study. 
Protocol Synopsis: Exploratory Efficacy 
Endpoints (pg. 13) 
Section 11.1: Efficacy Parameters (pg. 87-88) 
The endpoints associated with the two new 
exploratory objectives evaluating the change from 
baseline in total wart area and the percent change 
from baseline in total wart area were added. 
Section 8.2.2: Removal of Surgical Tape and 
Study Drug (pg. 56) 
Section 9.7.3: Removal of Surgical Tape (pg. 76) 
The reference to “warm” water was removed, as it 
is not required for the water to be warm to remove 
the study drug. 
Section 9.2: Screening Period (pg. 64) 
Section 9.3.1.1: Day 1 (Treatment Visit 1) (pg. 
66) 
Blood pressure was inadvertently referenced as 
part of the vital sign procedure, but instead should 
have said heart rate. All references to blood 
pressure have been replaced with heart rate to 

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SECTIONS/PAGES CHANGED 
DESCRIPTION OF CHANGES 
Administrative Update Throughout Protocol 
Updated Version to 2.0 and updated version date 
to 07 August 2019. 
Section 9.3.1.3: In-person Visit at 48 hours (±8 
hours) after Study Drug Administration (Part A 
only) (pg. 67) 
Section 9.3.2.1: Day 1 (Treatment Visit 2, 
Treatment Visit 3, Treatment Visit 4) (pg. 68) 
Section 9.4: End-of-Treatment Visit: Study Day 
84 (-0/+8 days) (pg. 71) 
Section 9.5: Follow-up Visits on Study Day 112 
(±7 days) and Study Day 147 (±7 days) (End-of- 
Study) (pg. 73) 
Section 9.6: Unscheduled Visit (pg. 74) 
match footnote ‘h’ in Table 1. Study Schedule of 
Assessments and Procedures (Part A and Part B) 
Section 10.8: Risks for Women of Child-bearing 
Potential or During Pregnancy (pg. 86) 
The definition of pregnancy was clarified to 
include any genetic contribution to a pregnancy 
by both male and female subjects. 
Synopsis: Exclusion Criteria (pg. 10) 
Section 7.2: Subject Exclusion Criteria (pg. 50) 
Removed reference to neoplasia in exclusion 
criteria #8, as it is already covered in exclusion 
criteria #15. 
Section 14.1: Investigator Information (pg. 93) 
Corrected reference to Manual of Operations to 
Investigator Brochure. The reference to a Manual 
of Operations was an oversight. 
Section 14.2: Investigator’s Study File (pg. 93) 
Removed reference to Manual of Procedures, as 
there is not a need for this document for this 
protocol. The reference to a Manual of Procedures 
was an oversight. 
Section 14.8: General Information (pg. 95) 
Corrected reference to Manual of Operations to 
Instructions For Use. The reference to a Manual 
of Operations was an oversight.