A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Study to Evaluate the Safety and Efficacy of VP-102 Topical Film-Forming Solution [0.7% (w/v) Cantharidin] in Subjects (2 Years and Older) With Molluscum Contagiosum
Phase: PHASE3
Conditions: Molluscum Contagiosum
Sponsor: Verrica Pharmaceuticals Inc.

CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
VP-102 
Clinical Protocol: VP-102-102 
CONFIDENTIAL 
CLINICAL PROTOCOL 
TITLE OF STUDY: 
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Study to Evaluate the 
Safety and Efficacy of VP-102 Topical Film-Forming Solution [0.7% (w/v) Cantharidin] in 
Subjects (2 years and older) with Molluscum Contagiosum 
Protocol VP-102-102 
      Date of issue:  24 February 2017 
      Version number: (5) 01 February 2018 
Sponsor: 
        Verrica Pharmaceuticals, Inc. 
        10 N. High Street, Suite 200 
        West Chester, PA 19380 

CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
 
 
VP-102 
Clinical Protocol: VP-102-102 
 
 
 
 
Page 3 
Acknowledgment of Responsibilities (Protocol Version 5) 
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 
 
 
 
 

CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
 
 
VP-102 
Clinical Protocol: VP-102-102 
 
 
 
 
Page 4 
STUDY SYNOPSIS 
Name of sponsor company: Verrica Pharmaceuticals, Inc. 
Name of finished product: VP-102 (0.7% w/v cantharidin) 
Name(s) of active ingredient(s): Cantharidin 
Title of study: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Study to Evaluate 
the Safety and Efficacy of VP-102 Topical Film-Forming Solution [0.7% (w/v) cantharidin] in 
Subjects (2 years and older) with Molluscum Contagiosum 
Number of sites: Up to 15 sites in the United States- (additional sites may be added if needed) 
Study period: 84 Days (12 weeks) 
Phase of development: Phase 3 
Objectives: The primary objective is to evaluate the efficacy of dermal application of VP-102 relative 
to placebo, when applied once every 21 Days for up to 4 applications, to treatable molluscum 
contagiosum (molluscum) lesions on subjects 2 years and older by assessing the proportion of subjects 
achieving complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit. 
 
The secondary objectives are: 
• 
to assess the safety and tolerability of VP-102, when applied once every 21 days for up to 4 
applications, to treatable molluscum lesions on subjects 2 years old and older by assessing 
adverse events including expected local skin reactions, physical examinations, and 
concomitant medications at End of Study compared to baseline.  
• 
to evaluate the efficacy of VP-102 relative to placebo by assessing the proportion of subjects 
achieving complete clearance of all treatable molluscum lesions at Visit 2.  Separate 
assessments for clearance will be repeated for both Visit 3 and Visit 4. 
Methodology: This is a Phase 3, randomized, double-blind, placebo (vehicle)-controlled, pivotal study 
to evaluate the safety and efficacy of VP-102 in 250 subjects (2 years and older) with molluscum lesions.  
Up to 15 sites will participate in the study. Additional sites may be added if needed. Subjects will receive 
Study drug in a 3:2 ratio of VP-102 containing 0.7% cantharidin or placebo/vehicle.  Lesion counts will 
be conducted by a blinded member of the research team (blinded assessor). The blinded assessor is not 
required to be the same person for each assessment.  
 
A dermatologic examination will be performed by a qualified investigator, which will include an 
assessment of local skin reactions at Treatment Visits 1, 2, 3, and 4.  A dermatologic examination will 
also take place at the Day 84 End of Study Visit (EOS). The CDLQI survey will be administered at 
Treatment Visits 1, 2, 3 and 4 prior to VP-102 or placebo (Study drug) application (if applied) and at the 
end of study (EOS) visit.  In addition, subjects will return to the clinic for a 24-hour assessment of 
evaluation of response to treatment (ERT) by the investigator or trained member of the research team 
within 48 hours (+/- 1 day) after the initial treatment visit. All subjects will receive application of the 
Study drug (VP-102 or placebo) to all treatable molluscum lesions every 21 days until complete 
clearance, or a maximum of 4 applications. Subjects will be given take home instructions describing 
what they might expect throughout the course of the study as well as recommendations for wound care, 
when it is important to call their doctor, and instructions for who to contact in an emergency. In addition, 
a Local Skin Reaction Guide will be provided and reviewed in detail at the clinic with the 
subject/guardian so the subject/guardian will be able to convey skin reactions in the ERT after treatments 
2-4. Additional ERT phone assessments will be conducted at 7 and 14 days after the initial treatment. 
Subsequent treatment visit follow-ups will include ERT phone assessments at 24 hours, 7 and 14 days 
after each treatment.  An in-person ERT will also be conducted at every visit prior to Study drug 

CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
 
 
VP-102 
Clinical Protocol: VP-102-102 
 
 
STUDY SYNOPSIS (continued) 
 
 
Page 5 
Name of sponsor company: Verrica Pharmaceuticals, Inc. 
Name of finished product: VP-102 (0.7% w/v cantharidin) 
Name(s) of active ingredient(s): Cantharidin 
application.  Assessments will be recorded by a research team member on the ERT form.  ERT visits 
may not be conducted by a blinded assessor. Phone assessments will not be conducted if there is no 
treatment administered.  The ERT includes questions related to removal of study drug and records the 
intensity of any local skin reactions, adverse events and concomitant medications (ConMeds). The 
subject and/or guardians will have time to ask questions and review any concerns.  Concerns and events 
will be assessed and in the event any adverse events present a safety concern, an unscheduled clinic visit 
will be scheduled.   
 
Each subject will be evaluated and treated as follows: 
 
• 
Screening Period (Up to 14 days prior to first treatment). 
 
• 
Safety Evaluation Period (Treatment Visit 1) 
o Confirm that subject still meets criteria (Dermatologic exam/lesion count; 
ability to attend study visits). 
o Lesion count and CDLQI assessment. 
o Study drug application. 
o Removal of Study drug 24 hours after application.  
o 24-hour, in-office ERT, within 48 hours (+/- 1 day) after treatment.  
o ERT phone calls at Days 7 and 14 after treatment.  
 
• 
Safety and Efficacy Evaluation Period (visits targeted 21 days after prior visit) 
o Treatment Visit 2: Lesion count by blinded assessor, dermatologic exam, 
CDLQI assessment, ERT, and Study drug application (if subject has treatable 
lesions remaining). Removal of Study drug 24 hours after application.  ERT 
phone calls at 24 hours and Days 7 and 14 after treatment (if treated).  
o Treatment Visit 3: Lesion count by blinded assessor, dermatologic exam, 
CDLQI assessment, ERT, and Study drug application (if subject has treatable 
lesions remaining). Removal of Study drug 24 hours after application.  ERT 
phone calls at 24 hours and Days 7 and 14 after treatment (if treated).  
o Treatment Visit 4: Lesion count by blinded assessor, dermatologic exam, 
CDLQI assessment, ERT, and Study drug application (if subject has treatable 
lesions remaining). Removal of Study drug 24 hours after application.  ERT 
phone calls at 24 hours and Days 7 and 14 after treatment (if treated).  
• End of Study (targeted 21 days after Treatment Visit 4 ) 
o Lesion count by blinded assessor, dermatologic exam, CDLQI and ERT. 
Study Duration: The study duration from Treatment Visit 1 through the end of study is approximately 
84 days (12 weeks). 
 
Subject Participation: Pre-study screening for eligibility (informed consent and assent, [assent when 
applicable], demographics, physical exam, prior and concomitant medications and molluscum and 

CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
 
 
VP-102 
Clinical Protocol: VP-102-102 
 
 
 
 
Page 6 
Name of sponsor company: Verrica Pharmaceuticals, Inc. 
Name of finished product: VP-102 (0.7% w/v cantharidin) 
Name(s) of active ingredient(s): Cantharidin 
medical history) can occur up to 14 days before, or on the same day as Study drug application.  Subjects 
that do not continue to meet criteria at Treatment Visit 1 will be discontinued and treated per standard 
of care. All lesions must be treatable at the time of randomization or the subject is not eligible to 
participate. Those subjects that meet the enrollment criteria will be randomized and treated with 
application of VP-102 or placebo to all molluscum lesions at Treatment Visit 1. Treatment will continue 
every 21 days to all treatable molluscum lesions until complete clearance or a maximum of 4 treatment 
sessions.  The EOS study visit will be completed 21 days after Treatment Visit 4, (EOS; Day 84).  In the 
event of scheduling conflicts in subsequent treatment visits, subjects may be scheduled 21 ± 4 days 
following their previous treatment for their next Treatment Visit and for their EOS visit.   
 
In the event subjects miss a treatment visit and are outside the 4-day study window, they may return and 
be treated at the next available opportunity with the subsequent visit scheduled 21 days after the actual 
treatment visit.  No study visits will be conducted after Day 100.    
Inclusion criteria:  
To qualify for inclusion in this study, subjects must:  
 
1. 
Be healthy subjects, at least 2 years of age or older. 
2. 
Consent to having all molluscum lesions treated and the physician must be willing to treat all 
molluscum lesions initially present.  Lesions within 10mm of the eyelid margins or the margin 
of any mucosal membrane should be evaluated carefully to ensure that they can be safely 
treated.  Non-mucosal genital area lesions and inflamed lesions are considered treatable.   
3. 
Be otherwise medically healthy with no clinically significant medical history as determined by 
the investigator. Subjects exhibiting active Atopic Dermatitis may be enrolled. 
4. 
On day of treatment refrain from application of all topical agents including alcohol-based 
sanitary products and sunscreens for a minimum of 4 hours before Study drug application. 
Topical agents including alcohol-based sanitary products and sunscreens may be used after 
application of the study drug so long as they are not applied within 5cm of treated skin 
lesions.  
5. 
Refrain from swimming, bathing or prolonged immersion in water or any liquids until the 
Study drug is removed.  
6. 
Have the ability or have a guardian with the ability to follow study instructions and be likely 
to complete all study requirements. 
7. 
Provide written informed consent or assent in a manner approved by the institutional review 
board (IRB) and/or have a parent/guardian provide written informed consent as evidenced by 
the signature on an IRB approved assent/consent form.   
8. 
Provide written authorization for use and disclosure of protected health information. 
9. 
Agree to allow photographs to be taken, (selected sites only) of selected lesions at every visit 
that will be used for training, publication and future marketing brochures. Photographs will be 
de-identified to those outside the research team. Efforts will be made to ensure that no photos 
with identifiable features are obtained. 
 

CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
 
 
VP-102 
Clinical Protocol: VP-102-102 
 
 
STUDY SYNOPSIS (continued) 
 
 
Page 7 
Name of sponsor company: Verrica Pharmaceuticals, Inc. 
Name of finished product: VP-102 (0.7% w/v cantharidin) 
Name(s) of active ingredient(s): Cantharidin 
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. 
Are systemically immunosuppressed or are receiving treatments such as chemotherapy 
or other non-topical immunosuppressive agents. 
3. 
Have any lesions present at baseline in anatomic locations that the 
subject/parent/guardian or the physician is unwilling to treat. 
4. 
Have had any previous treatment of molluscum including the use of cantharidin, 
antivirals, retinoids, curettage or freezing of lesions in the past 14 days. Additional 
treatments should not be implemented during the course of the study. 
5. 
Have a history of illness or any dermatologic disorder which, in the opinion of the 
investigator, will interfere with accurate counting of lesions or increase the risk of 
adverse events. 
6. 
History or presence of clinically significant medical, psychiatric, or emotional 
condition or abnormality that, in the opinion of the investigator, would compromise 
the safety of the subject or the quality of the data. 
7. 
Have a history or presence of hypersensitivity or an idiosyncratic reaction to the Study 
drug or related compounds, or drug product excipients (acetone, ethyl alcohol, 
nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and 
denatonium benzoate). 
8. 
Have a condition or situation that may interfere significantly with the subject’s 
participation in the study (e.g., subjects who required hospitalization in the 2 months 
prior to screening for an acute or chronic condition including alcohol or drug abuse), 
at the discretion of the investigator. 
9. 
Have received another investigational product within 14 days prior to the first 
application of the Study drug. 
10. 
Have been treated within 14 days with a product that contains cantharidin (topical or 
homeopathic preparations) for any reason prior to screening. 
11. 
Are sexually active or may become sexually active and are unwilling to practice 
responsible birth control methods. (e.g., combination of condoms and foam, birth 
control pills, intrauterine device, patch, shot and vaginal ring, etc.).  Withdrawal is not 
an acceptable method of birth control.  Females that have reached menarche must have 
a negative urine pregnancy test at each visit prior to treatment with Study drug. 
12. 
Are pregnant or breastfeeding. 
 
Test product, dose, and mode of administration: Study drug (VP-102 or placebo) is contained within 
a single-use applicator. Topical administration results in approximately 5 to 10 µL of Study drug per 
molluscum lesion (approximately 1mm to 4mm in diameter).  The VP-102 single-use applicator contains 
450µl (3.15 mg) of 0.7% w/v cantharidin.  The placebo single-use applicator contains 450µl of placebo 
solution with the same color and consistency as VP-102.  Up to 2 applicators may be used per subject, 
but a second applicator may only be necessary if treating >50 lesions. 

CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
 
 
VP-102 
Clinical Protocol: VP-102-102 
 
 
 
 
Page 8 
Name of sponsor company: Verrica Pharmaceuticals, Inc. 
Name of finished product: VP-102 (0.7% w/v cantharidin) 
Name(s) of active ingredient(s): Cantharidin 
Duration of treatment: The length of study participation from Treatment Visit 1 is 84 days (12 weeks).  
Up to 4 applications of Study drug at 21-day intervals will be followed by an EOS visit on Day 84.  
Subjects are instructed to wash all treated lesions with soap and warm water 24 hours after treatment. 
Study drug may be gently removed from individual lesions prior to 24 hours of application in the event 
of significant blistering, significant pain or treatment emergent AEs. Study drug should not be removed 
from the remaining unproblematic lesions until the 24-hour time point is reached. Washing of intact 
blisters should be gentle and without use of a washcloth.  Washing in a bath or shower is encouraged.  
Criteria for evaluation 
 
Efficacy: All randomized subjects (Intent-To-Treat) will be evaluated for efficacy.  Clinical response to 
treatment of molluscum lesions will be evaluated at each scheduled visit until EOS by counting all 
treatable molluscum lesions.   
 
Primary endpoint:  
• 
Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions 
(baseline and new) on the Day 84 visit (EOS).  
 
Secondary endpoints: 
• 
Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions 
(baseline and new) on the Day 63 visit. 
• 
Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions 
(baseline and new) on the Day 42 visit.  
• 
Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions 
(baseline and new) on the Day 21 visit. 
 
Exploratory endpoints: 
• 
Change from baseline of the composite score from the Children’s Dermatology Life Quality 
Index (CDLQI) assessment at the EOS visit to measure the quality of life and impact of skin 
disease in the subset of subjects 4 -16 years of age. 
• 
Percent reduction of all treatable molluscum lesions (baseline and new) from baseline at the 
EOS visit. 
• 
Change from baseline in the number of treatable molluscum lesions (baseline and new) at the 
EOS visit.  
• 
Proportion of subjects exhibiting a 75% or greater reduction of all treatable molluscum lesions 
(baseline and new) at the EOS visit. 
• 
Proportion of subjects exhibiting a 90% or greater reduction of all treatable molluscum lesions 
(baseline and new) at the EOS visit. 
• 
Subject reported spread to household members as measured by any new occurrence of 
molluscum in household members of subject. 
 
 
Safety: All subjects who meet the screening eligibility criteria for the study and receive at least one 
application of Study drug will be evaluated for safety.  The following safety parameters will be assessed:  
 
• 
Incidence of adverse events (AEs) throughout the study: 

CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
 
 
VP-102 
Clinical Protocol: VP-102-102 
 
 
STUDY SYNOPSIS (continued) 
 
 
Page 9 
Name of sponsor company: Verrica Pharmaceuticals, Inc. 
Name of finished product: VP-102 (0.7% w/v cantharidin) 
Name(s) of active ingredient(s): Cantharidin 
o A subject-by-subject AEs data listing, including verbatim term, preferred term, treatment, 
severity, and relationship to the Study drug, will be provided. 
o The number of subjects experiencing treatment emergent Adverse Events (TEAEs) and 
number of TEAEs will be summarized by treatment using frequency counts. 
o AEs will include all local skin reactions whether or not they are expected or related to 
study drug mechanism of action. 
 
• 
Local Skin Reactions (LSRs) of all previously treated areas will be assessed at each treatment 
visit using the protocol specific ERT form.  Additional, 24-hour in-person assessments will be 
conducted within 48 hours (+/- 1 day) after the initial treatment and at the EOS visit by the 
Investigator or trained personnel with the ERT form. 
o Subjects will have reviewed and be given take home instructions describing the potential 
local skin reactions and what they might expect throughout the course of the study as well 
as recommendations for wound care, when it is important to call their doctor, and 
instructions for who to contact in an emergency. 
 
• 
Sites will conduct ERT phone calls at 24 hours after Treatment Visits 2-4 as well as 7 and 14 
days after Treatment Visits 1-4 to assess treatment response, document any local skin reactions 
and any medical interventions taken.  ERT assessments will also be conducted 21 days after 
Treatment Visits 1-4 in-person prior to re-treatment. 
o A Local Skin Reaction Guide for subjects with specific photos identifying the various 
skin reactions and examples of intensity will be reviewed at the clinic with the 
subject/guardian by the research team.  Should a subject report experiencing excessive 
blistering or another adverse event needing physician assessment, they will be scheduled 
for an unplanned study visit and safety evaluation at the next available opportunity. 
 
• 
Medical history, vital signs, and physical examinations: 
o Medical history and limited physical exams will be collected for each subject.  A limited 
physical examination will be completed before the first treatment and at the EOS visit.  
Vital signs (temperature and heart rate) will be obtained before the treatment is applied at 
each visit and at the start of the EOS visit.  Unscheduled physical examinations will be 
performed when clinically warranted (e.g., subject reports symptoms classified as an AE 
requiring further evaluation).  
Safety considerations: Investigators should confirm the Study drug is completely dry (2-5 minutes) 
prior to the subject touching furniture with treated skin, putting on clothing and leaving the clinic.  It is 
important to prevent transference of the Study drug to healthy areas of skin to minimize any potential 
unnecessary reactions. VP-102 is considered highly flammable, even after drying.  Subjects should avoid 
fire, flame or smoking during treatment. 
 
Cantharidin has been shown safe for topical use, but it is highly toxic if ingested.  To deter potential oral 
ingestion, a bitter compound has been added to the Study drug.  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 24-hours after treatment or until the Study drug is removed.  

CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
 
 
VP-102 
Clinical Protocol: VP-102-102 
 
 
 
 
Page 10 
Name of sponsor company: Verrica Pharmaceuticals, Inc. 
Name of finished product: VP-102 (0.7% w/v cantharidin) 
Name(s) of active ingredient(s): Cantharidin 
 
Subjects should wash clothing, bedding and towels on a regular basis with hot water to minimize re-
inoculation.  Subjects are encouraged to wash their hands regularly with soap and water and discouraged 
from scratching or picking at lesions, which can spread disease. 
 
Households where siblings or friends are also diagnosed with molluscum should make every effort to 
avoid close contact with those individuals to prevent development of new lesions, recurrence, or spread 
of the disease.  Sharing of personal items such as towels, clothes, utensils or toys is strongly discouraged. 
 
Statistical methods: The primary objective of this study is to determine the efficacy of VP-102-treated 
subjects relative to placebo-treated subjects. The primary endpoint of this study is the proportion of 
subjects who achieve investigator assessed complete clearance of all treatable lesions on the Day 84 
EOS visit. 
 
The study is expected to enroll and randomize 250 subjects with molluscum lesions to test for treatment 
differences in the rates of complete clearance (primary endpoint).  Subjects will be randomized and 
treated in a double-blind manner with either VP-102 or placebo in a 3:2 ratio (approximately 150 subjects 
on VP-102 to 100 subjects on placebo). 
 
Study assumptions include the following: 
• 
a 10% drop out rate 
• 
a 20% clearance rate for subjects treated with placebo.  This is based on reported placebo 
treated clearance rates for placebo controlled studies, such as Aldara (26% clearance at 18 
weeks, extrapolated down to the 12 weeks treatment duration of this study) and several 
other placebo studies suggesting a similar clearance rate including Short 2006, Syed 1998, 
Dosal 2012, Burke 2004 and Theos 2004. 
• 
 a 44% clearance rate for subjects treated with VP-102.  This is based on a calculated 
clearance rate of 44% (11 cleared out of 25 completed subjects in NCT03017846) 
 
Using these assumptions, a sample size of 250 subjects with 3:2 stratification of active/placebo in each 
protocol based on a Pearson Chi-Square test with a two-sided significance level of 0.05 will provide 
>=95% power to detect treatment differences in clearance rates. 
 
All statistical tests will be two-sided with a significance level of α = 0.05, unless specified otherwise. 
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.  
 
A Pearson Chi-Square test will be used to compare the treated and placebo groups for the primary 
efficacy endpoint. Other binary endpoints also will be analyzed with this method.  
 
Continuous endpoints will be analyzed with an ANOVA model with a factor for treatment or an 
ANCOVA model with a factor for treatment and a covariate for number of baseline lesions.  Further 
details of analyses of other endpoints will be provided in the statistical analysis plan.    

CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
 
 
VP-102 
Clinical Protocol: VP-102-102 
 
 
STUDY SYNOPSIS (continued) 
 
 
Page 11 
Name of sponsor company: Verrica Pharmaceuticals, Inc. 
Name of finished product: VP-102 (0.7% w/v cantharidin) 
Name(s) of active ingredient(s): Cantharidin 
 
Adverse events, including local skin reactions, will be coded with the MedDRA® dictionary.  The 
number and percentage of subjects having treatment-emergent AEs will be tabulated by system, organ 
class and MedDRA preferred term with a breakdown by treatment group. 
 

CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
 
 
VP-102 
Clinical Protocol: VP-102-102 
 
 
 
 
Page 12 
Table 1  
Study Schedule of Assessments and Procedures 
Activities 
Screening
 a 
 
Up to 14 
days 
before 
Day 1 
Treatment 
1:  Day 1b 
24-
hour 
in-
person 
Visitm 
Day 7 
Phone 
Callm  
Day 
14 
Phone 
Call m 
Treatment 
2: Day 21 
24hr 
Phone 
Callm 
Day 7 
Phone 
Callm  
Day 
14 
Phone 
Callm  
Treatment 
3: Day 42b 
24hr 
Phone 
Call m  
Day 7 
Phone 
Call m  
Day 
14 
Phone 
Call m 
Treatment 
4:  Day 
63: 
EOTb 
24hr 
Phone 
Callm  
Day 7 
Phone 
Call m  
Day 
14 
Phone 
Callm  
End of 
Study: 
Day 
84:c 
Unscheduled 
Visith  
Informed 
Consent and 
Authorization  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/ 
Exclusion 
Criteria 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographicsd 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Height/Weight 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Prior Relevant 
Medical 
History  
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Molluscum 
History 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prior and 
Concomitant 
Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Vital 
Signs (T,P) e 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
Physical Examf 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Lesion Countg 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
Dermatologic 
Examtg 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
CDLQI 
Assessmenti 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
Sibling 
Assessment 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
Urine 
Pregnancy Testj 
 
X 
 
 
 
X  
 
 
 
X  
 
 
 
X 
 
 
 
X 
 
Photographsk 
 
X 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
Study Drug 
Applicationl 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
 
 
ERT 
Assessmentsm 
 
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 
X 
X 
Take Home 
Instructions, 
LSR 
guide/subject 
educationn 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
 
 
CDLQI: children’s dermatology life quality index; EOS = end of study; EOT = end of treatment; LSR = local skin reactions; ERT: evaluation of response to treatment; T,P= temperature, pulse 

CONFIDENTIAL 
Verrica Pharmaceuticals Inc. 
 
 
VP-102 
Clinical Protocol: VP-102-102 
 
 
 
 
Page 13 
 
a. 
Screening can occur up to 14 days prior to Study drug application on Day 1. Screening can occur on the same day as treatment Day 1/Study drug application. An IRB-approved 
ICF/Assent must be signed before any study specific procedures are performed. 
b.  Out of Window Parameters: Subjects may be scheduled 21+/- 4 days after treatment in the event of scheduling conflict. If possible, the next treatment visit should be scheduled 
21 days after the last treatment. The 24-hour onsite visit may be conducted within 48 hours of Treatment 1. The 24 hour phone contact may be conducted at +/- 4 hours.  The 
Day 7 and Day 14 phone contact may be conducted at +/- 24 hours.  If it is found during any treatment visit that all treatable molluscum lesions are cleared, the investigator will 
only conduct safety and ERT assessments and will not apply additional treatment.  
c..  Subjects who clear all lesions at study visits prior to Day 84 will return to the office for each treatment visit (even if no treatment is applied) to complete all study related 
assessments.  A final safety assessment and study completion form will be completed at the Day 84 (EOS) visit.  
d. Demographics: date of birth, sex, race/ethnicity will be collected. 
e. 
Vital signs (e.g., temperature & heart rate) will be obtained at each treatment prior to application of Study drug.  
f. 
Limited physical examination.  Symptom or AE-directed physical examination may be performed if warranted. (See Source/CRF for a more detailed description)   
g. Regional lesion counts (head/neck, chest/abdomen, back/buttocks, groin, upper/lower extremities) should be performed. Lesion counts completed at Treatment Visits 2, 3, 4 and 
EOS should be performed prior to 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. 
h. Unscheduled visits may be completed when clinically warranted (e.g. if a subject reports signs or symptoms classified as a treatment emergent AE and requires further evaluation) 
i. 
CDLQI assessment to be completed by the subject or guardian prior to Study drug application and each treatment visit regardless whether treatment was administered.  
j. 
To be performed prior to Study drug application and at EOS in any females of childbearing potential (females that are capable of menstruating). 
k.     Photographs of molluscum lesions will be obtained by the research team at selected clinical sites only for every visit for every randomized subject. Photos of the 3 most severe 
areas will be obtained. If there are no lesions remaining, the same areas will be photographed until EOS regardless of whether lesions are present. 
l.  Study drug may be gently removed from individual lesions prior to 24 hours of application in the event of significant blistering, significant pain or treatment emergent AEs. 
Study drug should not be removed from the remaining unproblematic lesions until the 24-hour time point is reached. 
m.   An Evaluation of Response to Treatment (ERT) in-person 24-hour assessment will be conducted within 48 hours (+/- 1 day) after the initial treatment application and after Study 
drug has been removed.  Phone assessments will be conducted at 7 and 14 Days after Treatment Visit 1.  Phone assessments will be conducted at 24 hours, 7 Days and 14 Days 
after Treatment Visits 2, 3 and 4.  Phone assessments will not be conducted for those subjects that did not receive treatment on their last visit.  Assessments will be recorded by 
the research team member on the Evaluation of Response to Treatment (ERT) form.  All ERT safety assessments must be conducted by a qualified member of the research team 
who is not utilized as a blinded assessor during the subject’s study participation. The blinded assessor may be utilized for a subject’s initial screening and enrollment but no 
additional study related activities other than lesion counts.  The blinded assessor does not have to be the same person at each visit.  
n.  Subjects will be given take-home instructions describing the possible local skin reactions 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. A Local Skin Reaction Guide for subjects will be reviewed at the clinic with the 
subject /guardian by the research team with copies provided for home use in the required follow-up phone 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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TABLE OF CONTENTS 
 
Page 
 
TABLE OF CONTENTS ............................................................................................................................................ 14 
LIST OF TABLES....................................................................................................................................................... 17 
LIST OF FIGURES ..................................................................................................................................................... 17 
LIST OF APPENDICES ............................................................................................................................................. 17 
LIST OF ABBREVIATIONS ...................................................................................................................................... 18 
1.0 
INTRODUCTION ................................................................................................................................ 19 
1.1 
MOLLUSCUM CONTAGIOSUM ........................................................................................................ 19 
1.2 
CANTHARIDIN .................................................................................................................................... 19 
1.2.1 
Nonclinical Studies with Cantharidin ........................................................................... 21 
1.2.2 
Clinical Studies with Cantharidin ................................................................................. 23 
1.3 
STUDY RATIONALE ........................................................................................................................... 26 
1.4 
DOSE RATIONALE ............................................................................................................................. 27 
1.5 
PRIMARY OBJECTIVE ....................................................................................................................... 27 
1.6 
SECONDARY OBJECTIVES ............................................................................................................... 27 
2.0 
STUDY DESIGN .................................................................................................................................. 28 
2.1 
BASIC DESIGN CHARACTERISTICS ............................................................................................... 28 
2.2 
STUDY POPULATION ........................................................................................................................ 31 
2.2.1 
Inclusion Criteria .......................................................................................................... 31 
2.2.2 
Exclusion Criteria ......................................................................................................... 32 
2.3 
ENDPOINTS ......................................................................................................................................... 33 
2.3.1 
Safety ............................................................................................................................ 34 
2.3.2 
Efficacy ......................................................................................................................... 35 
2.4 
RANDOMIZATION AND BLINDING ................................................................................................ 35 
3.0 
DRUGS AND DOSAGES .................................................................................................................... 38 
3.1 
IDENTIFICATION AND DESCRIPTION OF INVESTIGATIONAL PRODUCT ............................. 38 
3.1.1 
Investigational Product ................................................................................................. 38 
3.1.2 
Labeling ........................................................................................................................ 38 
3.2 
DOSING INSTRUCTIONS AND SCHEDULE .................................................................................... 41 
3.3 
STORAGE AND HANDLING OF INVESTIGATIONAL PRODUCT ............................................... 42 
3.4 
CONCOMITANT MEDICATIONS ...................................................................................................... 43 
4.0 
EXPERIMENTAL PROCEDURES ................................................................................................... 44 
4.1 
OVERVIEW: SCHEDULE OF TIME AND EVENTS ......................................................................... 44 
4.2 
MEASUREMENTS AND EVALUATIONS......................................................................................... 46 
4.2.1 
Screening Period (Up to 14 days prior to Treatment Visit 1) ........................................ 46 
4.2.2 
Safety Evaluation Period (Treatment Visit 1) ............................................................... 47 
4.2.3 
Safety and Efficacy Evaluation Period: (Treatment Visits 2, 3 and 4) .......................... 48 
4.2.4 
End of Study (Day 84): ................................................................................................. 50 

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5.0 
PROCEDURES FOR HANDLING ADVERSE EVENTS AND SERIOUS ADVERSE 
EVENTS ................................................................................................................................................ 50 
5.1 
DEFINITION OF AN ADVERSE EVENT ........................................................................................... 50 
5.2 
DEFINITION OF A SERIOUS ADVERSE EVENT ............................................................................ 53 
5.3 
RECORDING ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ...................................... 54 
5.4 
ASSESSMENT OF INTENSITY .......................................................................................................... 55 
5.5 
ASSESSMENT OF CAUSALITY ......................................................................................................... 55 
5.6 
EXPECTEDNESS OF SERIOUS ADVERSE EVENTS ...................................................................... 56 
5.7 
REPORTING OF SERIOUS ADVERSE EVENTS .............................................................................. 57 
5.8 
FOLLOW-UP OF ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ................................ 58 
5.9 
PREGNANCY ....................................................................................................................................... 58 
6.0 
STUDY OR SITE TERMINATION AND SUBJECT DISCONTINUATION ............................... 59 
6.1 
SUBJECT DISCONTINUATION ......................................................................................................... 59 
6.1.1 
Adverse Event ............................................................................................................... 59 
6.1.2 
Intercurrent Illness ........................................................................................................ 59 
6.1.3 
Noncompliance ............................................................................................................. 59 
6.1.4 
Refusal of Investigational Product Administration ....................................................... 60 
6.1.5 
Withdrawal of Consent ................................................................................................. 60 
6.2 
PREMATURE STUDY OR SITE TERMINATION ............................................................................. 60 
7.0 
DATA COLLECTION AND PROCESSING AND STATISTICAL ANALYSIS .......................... 62 
7.1 
DATA COLLECTION AND PROCESSING ........................................................................................ 62 
7.2 
STATISTICAL ANALYSIS .................................................................................................................. 63 
7.2.1 
General Overview ......................................................................................................... 63 
7.2.2 
Populations of Interest .................................................................................................. 63 
7.2.3 
Efficacy Analysis .......................................................................................................... 64 
7.2.4 
Safety Analysis ............................................................................................................. 64 
7.2.5 
Interim Analysis ............................................................................................................ 65 
7.2.6 
Sample Size ................................................................................................................... 65 
7.2.7 
Handling of Missing Data ............................................................................................. 66 
7.3 
INFORMED CONSENT/ASSENT AND AUTHORIZATION FOR USE AND DISCLOSURE 
OF PROTECTED HEALTH INFORMATION ..................................................................................... 68 
7.4 
STUDY DOCUMENTATION .............................................................................................................. 68 
7.4.1 
Investigator Information ............................................................................................... 68 
7.4.2 
Investigator’s Study Files .............................................................................................. 68 
7.4.3 
Electronic Case Report Forms and Source Documentation .......................................... 69 
7.4.4 
Retention of Study Documents ..................................................................................... 69 
7.5 
CONFIDENTIALITY ............................................................................................................................ 70 
7.5.1 
Data ............................................................................................................................... 70 
7.5.2 
Subject Anonymity ....................................................................................................... 70 
7.6 
PROTOCOL COMPLIANCE ................................................................................................................ 70 

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7.7 
STUDY MONITOR FUNCTIONS AND RESPONSIBILITY ............................................................. 71 
7.8 
GENERAL INFORMATION ................................................................................................................ 71 
8.0 
REFERENCES ..................................................................................................................................... 72 
8.1 
UNPUBLISHED MANUSCRIPT ......................................................................................................... 75 
APPENDICES ............................................................................................................................................................. 76 
 

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LIST OF TABLES 
 
 
Page 
 
Table 1  
Study Schedule of Assessments and Procedures .......................................................................... 12 
Table 2 
Classification of AEs by Intensity ................................................................................................ 55 
Table 3 
Assessment of Causality of AEs ................................................................................................... 56 
Table 4 
Timeline for Reporting SAEs ....................................................................................................... 57 
 
 
LIST OF FIGURES 
 
Page 
 
Figure 1. 
Clinical Trial Labeling of Study Drug  ........................................................................................ 39 
 
 
LIST OF APPENDICES 
 
 
Appendix 1  
 Children’s Dermatology Life Quality Index Scoring Instructions 
Appendix 2  
 Version History and Summary of Changes 
 
 

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LIST OF ABBREVIATIONS 
 
 
AE 
adverse event 
AMES 
Genetic Toxicity Study: in vitro Bacterial Reverse Mutation 
CDLQI 
children’s dermatology life quality index 
cm 
centimeter 
eCRF 
electronic case report form 
EOS 
end of study 
EOT 
end of treatment 
EDC 
electronic data capture 
ERT 
Evaluation of response to treatment 
FDA 
Food and Drug Administration 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
ID 
identification 
IFU 
instructions for use 
IRB 
institutional review board 
mg 
milligrams 
mm 
millimeter 
Molluscum 
molluscum contagiosum 
LSRs 
local skin reactions 
SAE 
serious adverse event 
SOP 
standard operating procedure 
TEAE 
treatment emergent adverse event 
T24 
human bladder carcinoma cells 
TSGH 8301 
human urinary bladder carcinoma cell line 
uL 
units per liter 
VP-102 
Verrica Pharmaceuticals-102 (0.7% w/v cantharidin) 
w/v 
weight/volume 
 
 

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1.0 
INTRODUCTION 
1.1 
MOLLUSCUM CONTAGIOSUM 
The causative agent of molluscum contagiosum (molluscum) is the molluscum virus, a 
dermatotropic DNA poxvirus.  Molluscum is common in the pediatric population and 
is prevalent worldwide.  It produces small flesh-colored papules and papulovesicles, 
1-4 mm in diameter, which typically have an umbilicated or dimpled center.  There is 
often little inflammation associated with molluscum papules, and the presence of an 
inflammatory reaction to such papules often heralds resolution of the disease.  
Molluscum lesions are generally not painful, but they may itch or become irritated. 
Picking or scratching the bumps can lead to autoinoculation, secondary bacterial 
infection or scarring.   
Molluscum is spread readily by autoinoculation and by person-to-person contact.  The 
virus may also be transmitted by touching objects such as towels, clothing, or toys. 
Most immunocompetent individuals will spontaneously clear the disease in an average 
of 13 months, although 25% children still have the disease after 18 months.[3]  Spread 
to siblings and friends, as well as the development of additional lesions in neighboring 
sites during this time causes parental angst, socialization challenges for the afflicted 
individuals[1, 2] and has been shown to negatively impact quality of life.[3] The highest 
incidence is in children up to 14 years of age, where the incidence rate ranges from 12 
to 14 episodes per 1,000 children per year.[4] 
There is no approved product by the Food and Drug Administration (FDA) for the 
treatment of molluscum.  Given that there are no approved options, physicians employ 
a variety of treatment approaches including (a) benign neglect; (b) curettage; (c) 
cryotherapy; (d) expressing the molluscum bodies; (e) retinoic acid creams; (f) caustic 
agents; (g) topical immunotherapeutics; and (h) non-standardized, compounded 
cantharidin products of various purity, formulations, and strengths.  
1.2 
CANTHARIDIN 
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.  Blister beetles are found in many parts of the world, 
including the southern United States and Asia (Mylabris Cichorii L and Mylabris 

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phalerata).  Lytta vesicatoria, a metallic green beetle, was primarily used as a source 
of cantharidin in the early 1900s, as it is endemic to the United States.  Regardless of 
species of blister beetle, the structure of the cantharidin molecule is maintained with 
only variations in the quantity of compound that can be readily isolated.  The Mylabris 
species of beetle contains a much greater concentration of cantharidin and is the 
primary type of beetle used in modern cantharidin preparations. 
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 release of neutral serine proteases resulting in the destruction of intercellular 
desmosomes responsible for holding the layers of the skin together.[5]  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.  
In almost all subjects, this process does not cause a scar, as the underlying dermal layer 
of skin is undamaged.  Cantharidin has no known direct antiviral effects. 
Many physicians prefer cantharidin to other therapies for the treatment of molluscum 
such as cryotherapy, curettage or pricking individual lesions with subsequent 
expression of molluscum bodies because it is painless upon application, requires only 
limited treatment cycles for significant lesion reduction or complete resolution and is 
well-tolerated by subjects, most of whom are children.  Furthermore, cantharidin’s long 
history of use has provided strong evidence of its safety when applied topically.  
Although cantharidin has been used extensively for decades in the treatment of several 
dermatologic conditions including molluscum and verruca vulgaris, specifications for 
the quality of active pharmaceutical ingredient or a standardized formulation have 
never been established.  Furthermore, a lack of reliable and regulated vendors of the 
compounded drug increases the chance of the drug product being inappropriately 
prepared, tested, stored or applied, which in turn increases the potential for unintended 
or even dangerous consequences in the future.  Most currently used cantharidin 
preparations are prepared as 0.7% w/v (weight/volume) solutions in an acetone solvent 
with a flexible-collodion base in a screw-top glass bottle at volumes intended for 
repeated use across multiple subjects by the medical professional.  This type of 
container closure system paired with highly volatile formulations presents multiple 
challenges.  Current clinical practice, which reuses the same bottle on multiple patients, 

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increases the risk of cross-contamination and viral transmission.  Furthermore, due to 
the presence of volatile solvents in the preparation, evaporation from multiple uses 
heightens the risk of increased concentration and viscosity of the cantharidin in solution 
and creates a scenario where highly-concentrated material may be applied to the 
patient’s skin.  Many formulations also lack formal stability studies and medical 
professionals often will just use the material until it is “too thick” to apply.  As a 
consequence, many patients are likely receiving much more drug than is clinically 
necessary to treat their molluscum lesions.  While this does provide evidence of the 
safety profile for the drug, it also introduces unnecessary risk to the patient.  Further, 
the nature of the liquid product coupled with the traditional application strategy of using 
the wooden end of a cotton-tipped swab makes it difficult to apply the minimum 
amount of drug necessary to achieve the desired effect.  Complete treatment of all 
lesions is further confounded by the fact that there is no visual indicator present in the 
formulation to clearly identify for physicians, patients and caregivers where the drug 
has already been applied during the treatment session. 
To address these current shortfalls, Verrica Pharmaceuticals, Inc. has developed VP-
102, a 0.7% w/v cantharidin formulation, consistent with the predominant 
concentration of cantharidin used by physicians.  Study drug (VP-102 or placebo) will 
be administered with a single-use applicator to minimize cross-contamination and 
concentration changes during use.  Each VP-102 applicator contains 450 µL 
(microliters) of drug product, with each VP-102 unit containing 3.15 mg of cantharidin.  
Gentian violet, a dye common in surgical markers, has also been included to facilitate 
physician recognition of treated vs. untreated molluscum lesions.  Finally, to afford 
additional safety and deter potential oral ingestion of the drug by young subjects, the 
oral deterrent denatonium benzoate has been included.  
1.2.1 
Nonclinical Studies with Cantharidin 
Preclinical published data for cantharidin focuses primarily on its effect on epithelial 
cells, endothelial cells, various carcinoma cells, and myocardial cells.  Data most 
germane to the current study are those examining the effect of cantharidin on epidermal 
cells, since it is absorbed through the lipid layer of the skin, inducing acantholysis and 
desmosome disruption of the epidermal cell layer leading to small blisters.   
Cantharidin has shown potent in vitro chemotherapeutic activity against a number of 
human cancer cell types including human bladder cancer T24 cells[6] and human 

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bladder cancer TSGH 8301 cells.[7]  Pharmacodynamic drug-drug interaction studies 
of topically applied cantharidin on rat ears showed a decreased anti-inflammatory 
response from dexamethasone, hydrocortisone, and prednisolone.[8] 
In vitro studies of cantharidin produced positive inotropic responses in guinea pig 
papillary muscle,[11] human myocardial tissue,[12, 13] and bovine coronary artery 
rings.[13]  Cantharidin inhibits mobilization of synaptic vesicles and depresses calcium 
release from the sarcoplasmic reticulum, affecting motor function[14] and causing 
contraction of bovine smooth muscle.[15]   
In vitro studies in cultured Chinese hamster cells[26]  showed that cantharidin was not 
clastogenic at the doses tested, but a significant increase in chromosomal aberrations 
was noted only at the highest concentration tested (10% versus 1 – 2% in the vehicle 
group), a concentration that was considered cytotoxic, i.e. cell survival was 36.1%. 
Cantharidin at 1 µg/mL (100% survival) and 2 µg/mL (36.1% survival) induced 
endoreduplication (39% and 65% of the cells, respectively), an indication that this 
agent can interfere in vitro with the formation of the mitotic spindle apparatus and that 
it may be aneugenic. 
Cantharidin was evaluated in several GLP-compliant genotoxicity studies.  Cantharidin 
was negative in bacterial reverse mutation assays (AMES test) and does not possess 
mutagenic potential. Cantharidin was also evaluated in a chromosomal aberration assay 
with human peripheral blood lymphocytes, but due to assay limitations, no conclusions 
can be made about its clastogenic potential in human cells.  
Safety pharmacology studies have been conducted, primarily following oral 
administration rather than dermally, due to the limited anticipated systemic exposure 
following topical administration. One study focused on the cardiovascular and renal 
effects of ingested cantharidin in rats.  This study showed that cantharidin did not affect 
heart rate for the experimental period of 24 hours but decreased urine volume.[9] In a 
rabbit study, intermediate (1.3 or 1.5 mg/kg) and high (1.9 mg/kg) doses of intravenous 
bolus injection of cantharidin led to cardiac arrest, but no effects were noted at lower 
doses (0.6 or 1.1 mg/kg).[10] 
 

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1.2.2 
Clinical Studies with Cantharidin 
Cantharidin has been used by healthcare providers for decades to treat molluscum.  The 
following summarizes significant studies documenting safety and efficacy of this 
treatment modality. 
Prospective studies 
An ongoing pharmacokinetic study is being conducted to determine if subjects in the 
upper quartile of severity of molluscum infection (defined as having greater or equal to 
21 lesions) who are treated with VP-102 have any systemic exposure to cantharidin in 
blood.  As of 1 September 2017, plasma samples from 7 subjects with severe disease 
(greater than 21 lesions treated) have been evaluated (NCT03186378) with an 
application duration of 24 hours.  Cantharidin was below the lower limit of 
quantification (1 ng/ml) in the plasma from these subjects at 2, 6 and 24 hours following 
application.  This study is still ongoing with a goal of collecting plasma from 16 
subjects.  Thus far, the data support the conclusion that cantharidin plasma levels are 
below the lower limit of quantification following the treatment of molluscum with VP-
102 and that VP-102 treatment presents no risk of systemic toxicity. 
A recently completed bridging study was implemented to confirm that VP-102 is 
similar in safety and efficacy to a 0.7% cantharidin compounded formulation studied 
previously.  In this study, VP-102 appeared to be safe and well tolerated, with no 
unexpected treatment related adverse events reported during its application to over 
1,700 molluscum lesions in 30 subjects.  25 subjects completed the study and were 
evaluable for lesion clearance.  The first cohort of subjects in this study was treated 
with a 6-hour application duration.  The second cohort was treated with a 24-hour 
application duration.  There was no significant safety difference between these 
treatment cohorts and both treatment durations were well tolerated with many subjects 
experiencing application site blistering and some experiencing transient mild pain and 
pruritus.  The complete clearance rate within 12 weeks in the 6-hour cohort for subjects 
that completed the study (N=13) was 46.2% (6/13). The complete clearance rate within 
12 weeks in the 24-hour cohort for subjects that completed the study (N=12) was 41.6% 
(5/12).   In conclusion, the ability of VP-102 to completely clear molluscum has not 
been shown to be significantly different from the compounded 0.7% cantharidin 
formulation. In addition, both compounded cantharidin and VP-102 perform 
significantly better than the best estimate of placebo.  Thus, this bridging study met its 

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primary objective in demonstrating that VP-102 appears to be safe and effective in the 
treatment of pediatric molluscum (NCT# 03017846). 
Schairer et al.[16] published an interim analysis of a two phase, double-blind, 
placebo-controlled study of the first 52 subjects (2 to 17 years old) who were randomly 
assigned to receive two treatments with topical 0.7% w/v cantharidin or placebo (with 
and without occlusion) administered 3 weeks apart. Lesion counts and adverse events 
were assessed every 3 weeks.  Most recently, Garelik et al. (unpublished manuscript) 
provided a full analysis of the entire population treated in the Schairer et al., study.  
Cantharidin or placebo vehicle was administered in a blinded manner at week 0 and 
week 3 to 94 subjects with a maximum of 50 lesions.  At 6 weeks (following 2 
applications spaced 3 weeks apart), a greater percentage of subjects achieved complete 
lesion clearance in the cantharidin versus placebo arms (p < 0.05).  Subjects who did 
not have clearance at week 6 were crossed over to treatment with open-label cantharidin 
every 3 weeks until all lesions were resolved.  In this 94-subject study, 78.4% of the 
participants achieved total lesion clearance in a median of three visits (range 2 to 
9 visits).  In the open label group, the median time to clearance was 9 weeks (3 
additional treatments with cantharidin for a total of up to 5 overall) with 87.8% of 
subjects achieving complete resolution.  There were no reported treatment related 
adverse events, demonstrating that cantharidin is an effective and safe modality for 
molluscum when applied as an in-office treatment.[16] 
In another exploratory double-blind, placebo-controlled study, 29 children, with no 
upper limit of lesion count, were treated every 10-14 days over a 2-month period for a 
maximum of 5 visits.[17]  Only 1-2 lesions were treated on the first visit and up to 
20 lesions were treated on subsequent visits.  By visit 5, the median lesion count for 
the cantharidin group was 8 (a reduction of 41% from baseline) whereas the median 
lesion count for the placebo group was 18 (a reduction of 8% from baseline).  Complete 
clearance of lesions was seen in 15% (2 of 13) of cantharidin-treated subjects and 9% 
(1 of 16) of the placebo group.   
Lastly, a prospective, four-arm, open-label, randomized study addressed the efficacy 
of four recognized treatments for molluscum (curettage, 0.7% cantharidin, salicylic 
acid and lactic acid, imiquimod).[18]  For each subject in the cantharidin treatment 
group, 10 lesions were selectively treated, and the remaining lesions were removed by 
curettage.  Efficacy was based on the number of visits needed for clearance, incidence 

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of side effects, and parental and subject satisfaction.  Following curettage, cantharidin 
had the best tolerability and efficacy profile in this single center study where the 
investigators were primarily experienced with curettage as the primary treatment 
modality. Adverse events (AEs) reported in these studies were limited to blistering and 
pain at the application site.  Less frequently, redness, pruritus, and pigment changes 
have been reported with cantharidin use. 
Retrospective studies 
Results of prospective studies are supported by retrospective reports of the treatment 
of molluscum with cantharidin.  In a retrospective study of 62 cases of pediatric 
molluscum involving facial lesions, treatment with cantharidin resulted in the 
following incidence of side effects; 18% discoloration, 10% blistering greater than 
expected, and 10% pain.  Pruritus, scarring, irritation, bleeding, and spreading of 
lesions were uncommonly cited.  A satisfaction survey of parents following treatment 
found an average score of 8.7 out of 10.  The authors concluded that cantharidin is a 
safe and effective ﬁrst-line treatment for molluscum lesions on the face.[19] 
Moye, et al.[20] performed a retrospective analysis of 405 molluscum subjects (aged 
5 months to 20 years old) treated with 0.7% w/v cantharidin.  The study involved 
1,056 treatments to over 9,688 lesions with an average of 2.6 visits per subject.  A 
parent satisfaction assessment found that 86% of parents were satisfied with the 
cantharidin treatment or would opt to use it again, while 1.2% of parents were 
dissatisfied, citing irritation and pain as the reasons.  Less than 1% of parents preferred 
another therapeutic option.  The most common AEs in the population were blistering 
(11%), pain at the treatment site(s) (7%), and severe blistering (2.5%).  Less than 1% 
of subjects experienced pruritus, possible mild infection, significant irritation, 
non-severe pain after treatment, and bleeding.  
Cathcart, et al.[21] also reported on parental satisfaction, efficacy, and AEs in 
54 children (aged 3 months to 13 years old) with molluscum after treatment with 
cantharidin.  Parents reported 96% improvement after-treatment with a 78% 
satisfaction rating.  Overall, 46% of subjects experienced AEs, including pain, pruritus, 
secondary infection, and temporary hypopigmentation while 9% experienced severe 
pain.  The authors concluded that cantharidin “should be considered a potential 
frontline treatment” for molluscum. 

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Silverberg, et al.[22] conducted a retrospective study to determine the safety, efficacy 
and parental satisfaction in 300 children (mean aged 4.7 years old) with molluscum 
after treatment with 0.7% w/v cantharidin.  90% of subjects experienced complete 
clearing, 8% experienced significant improvement and 2% reported that the therapy 
was ineffective.  92% of subjects had blistering, 37% experienced erythema (which 
lasted up to 3 weeks), 14% had mild to moderate pain, and 8% had a change in 
pigmentation at the site of application.  Importantly, no major side effects or secondary 
bacterial infections were noted.  95% of parents stated that they would proceed with 
cantharidin therapy again if necessary. 
The above studies provide evidence of the safety, efficacy, and widespread use of 0.7% 
w/v cantharidin topical solution in the treatment of molluscum in children of all ages, 
with no serious advents events reported.  However, there is a wide variation in the 
quality of the research conducted, timing between applications, duration of exposure 
of lesions to cantharidin and the exact formulations of cantharidin used.   
1.3 
STUDY RATIONALE 
For many dermatologists, 0.7% w/v cantharidin has been the treatment of choice for 
molluscum for decades.  However, cantharidin remains an unapproved drug, and there 
is no reliable or controlled source on the market.  This study will evaluate VP-102, a 
controlled, highly-pure, standardized form of topical cantharidin manufactured under 
good manufacturing practices in order to address the problems associated with 
currently available compounded cantharidin products and the needs of subjects and 
medical professionals. 
On average, it takes over 13 months to naturally clear molluscum lesions.  
Unfortunately, one in four children with diagnosed molluscum experience persistent 
lesions even after 18 months.  Subjects with more than 10 molluscum lesions 
experience a significant negative effect on their quality of life.[3] 
The primary objectives of the current study will be to evaluate the safety and efficacy 
of dermal application of VP-102, when administered once every 21 days for up to 
4 applications in subjects age 2 years or older.  Safety of the treatment will be evaluated 
by assessing AEs, physical examinations, Evaluation of Response to Treatment (ERT), 
and concomitant medications compared to baseline.   

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1.4 
DOSE RATIONALE 
A 0.7% w/v cantharidin solution is the recognized therapeutic dose of cantharidin for 
molluscum treatment in dermatological clinical practice[17, 19-23].  A lower dose of 0.5% 
was found to be ineffective in the treatment of molluscum.[24]   The 0.7% w/v dose was 
determined to be safe and effective in a recent double-blind Phase 2 study of 94 subjects 
for the treatment of childhood molluscum[16] Garelik et al. (unpublished manuscript), 
and in a recently completed study of VP-102 (NCT# 03017846) with 30 subjects 
treated.  
The anticipated VP-102 label will focus on treatment of subjects with one or more 
treatable molluscum lesions.  Each lesion is typically about 1 mm to 4 mm (0.78 mm2 
to 12.56 mm2) in diameter and Verrica estimates that approximately 5-10 µL of VP-
102 is sufficient to cover each lesion.  A single use applicator should be sufficient to 
treat up to approximately 50 molluscum lesions and no more than 2 applicators may be 
used per treatment on each subject. 
OBJECTIVES 
 
1.5 
PRIMARY OBJECTIVE 
The primary objective is to evaluate the efficacy of dermal application of VP-102 
relative to placebo, when applied once every 21 Days for up to 4 applications, to 
treatable molluscum contagiosum (molluscum) lesions on subjects 2 years and older 
by assessing the proportion of subjects achieving complete clearance of all treatable 
molluscum lesions (baseline and new) on the Day 84 (EOS) visit. 
1.6 
SECONDARY OBJECTIVES 
The secondary objectives are as follows: 
• to assess the safety and tolerability of VP-102, when applied once every 21 days 
for up to 4 applications, to treatable molluscum lesions on subjects 2 years old or 
older by assessing adverse events, including local skin reactions, physical 
examinations, and concomitant medications at EOS compared to baseline.  
• to evaluate the efficacy of VP-102 relative to placebo by assessing the proportion 
of subjects achieving complete clearance of all treatable molluscum lesions at Visit 

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2. Separate assessments for clearance will be repeated for both Visit 3 and Visit 4. 
2.0 
      STUDY DESIGN 
2.1 
BASIC DESIGN CHARACTERISTICS 
This is a Phase 3, multi-center, randomized, double-blind, placebo (vehicle)-controlled, 
pivotal study that will be conducted in the United States to determine the efficacy and 
safety of VP-102 following treatment of molluscum lesions for up to 4 treatments, 
every 21 days, with VP-102/placebo in 250 pediatric subjects (2 years or older).  
Subjects will receive active 0.7% cantharidin VP-102 or placebo in a 3:2 ratio.  
Duration of molluscum lesions prior to Treatment Visit 1 will be recorded but will not 
be an inclusion/exclusion requirement.  
Study drug (VP-102 or placebo) will be supplied in single-use applicators, with one 
applicator sufficient to treat up to approximately 50 molluscum lesions.  If required, 
due to the number and size of lesions, a second single-use applicator may be used per 
subject.  No more than 2 applicators will be permitted per subject per treatment. The 
film-forming Study drug solution will be applied and left on the lesions for 24 hours 
before the subject/guardian washes the lesions with soap and warm water.  Study drug 
may be removed prior to the 24-hour time point in the event significant blistering, 
significant pain or treatment-emergent AEs are experienced. 
Molluscum lesions will be treated without occlusion in all anatomic areas including the 
face, trunk, back, arms, legs, hands, feet, anogenital region and buttocks.  For study 
enrollment, the physician must be willing to treat all lesions initially present.  Lesions 
that develop during the course of the study within 10mm of the eyelid margins or the 
margin of any mucosal surface should be evaluated carefully to ensure that they can be 
safely treated.  Non-mucosal genital area lesions and inflamed lesions are considered 
treatable.     
The study duration from Treatment Visit 1 through the Day 84 (EOS) visit is 
approximately 84 days (12 weeks).  Pre-study screening for eligibility (informed 
consent, and assent (if assent is applicable), demographics, physical exam, prior and 
concomitant medications and molluscum and medical history) will occur up to 14 days 
before, or on Treatment Visit 1.  Subjects who do not meet the inclusion criteria at 
Treatment Visit 1 will be discontinued and treated per standard of care.  Those subjects 

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that continue to meet criteria will be randomized per IWRS and treated with application 
of VP-102 or placebo solution to all molluscum lesions every 21 days (± 4 days) for a 
maximum of 4 treatment sessions.  Subjects who completely clear all treatable lesions 
prior to Day 84 will complete the remainder of the Treatment Visits in order to monitor 
safety.  If new lesions appear on a previously cleared subject, they should be treated. 
In the event of scheduling conflicts in subsequent visits after the first treatment, 
subjects may be scheduled on 21 ± 4 days following their previous treatment.  The next 
study visit should then be scheduled 21 days after the previous treatment.  In the event 
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 treatment 
visit scheduled 21 days later to facilitate up to 4 treatments within 84 Days. 
 The final study visit assessment must be completed on or before Day 100. Should it 
become clear that the subject would be unable to complete the EOS on or before Day 
100, the subject should be brought in for their EOS visit on or before Day 100, 
regardless of the number of days since their last Treatment Visit (eg., a missed 
treatment may cause the subject to fall outside this window of 16 days). 
Subjects who are unable to attend the in-office EOS visit may have the option of an 
EOS home visit by a qualified member of the research team if this is within the site’s 
standard of practice. Consent for Home Visit will be included in the initial consent 
process. Subjects who continue to require treatment outside the specified study 
windows must be treated allowing for EOS to occur before or on Day 100.  Subjects 
who are not assessed as 100% cleared of all treatable lesions at the EOS visit will have 
completed the study and will be further treated per standard of care at their physician’s 
discretion but may not be re-enrolled in this study. 
Evaluation of Response to Treatment (ERT) will be performed by the investigator or 
trained member of the research team, who is not a blinded assessor for that subject, at 
each treatment visit. An additional 24-hour in-office assessment will be conducted 
within 48 hours (+1 day) after the first treatment and at the EOS visit.  Qualified study 
personnel who are not blinded assessors for the subject, will conduct ERT phone calls 
at 7 and 14 days after Treatment Visits 1.  In addition, ERT phone calls at 24-hours as 
well as 7 and 14 days after Treatment Visits 2, 3 and 4 will be performed to assess 
treatment response, document any local skin reactions and any medical interventions 
taken if treatment was administered. The following clinical responses will be recorded 

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as part of the Evaluation of Response to Treatment (ERT) with type and intensity 
recorded on the AE log: blistering, pain, pruritus, erythema, edema, erosion/ulcerations, 
flaking/scaling/dryness, scabbing/crusting, and pigmentation changes (hyperpigmentation 
or hypopigmentation).  Scarring will be assessed at each treatment visit and the EOS visit 
by a qualified medical professional. Scarring information will not be collected as part of 
the phone assessment. Additional information related to AE’s and ConMeds will also be 
collected during each assessment. 
Subject quality of life and measure of impact of skin disease will be collected using the 
Children’s Dermatology Life Quality Index Questionnaire.  The CDLQI questionnaire 
is validated for use in children ages 4-16 years of age but will be administered to all 
study subjects and/or their guardians regardless of age.  It should be handed to the 
subject who is asked to fill it in with the help of a parent/guardian as needed.  The 
subject or guardian will be given completion instructions to evaluate their skin 
condition as it specifically relates to molluscum contagiosum.  They will be guided to 
disregard the impact of any other concomitant skin conditions like atopic dermatitis 
during completion.  The CDLQI should be scored by the site using the guidelines in 
Appendix 1.    
Subjects will be given take-home instructions describing the potential local skin 
reactions and what they might expect throughout the course of the study. The 
instructions include recommendations for wound care, when it is important to call their 
doctor, who to contact in the event of emergency and a 24-hour emergency number.  
The additional scheduled visits and calls up through the next treatment visit, or EOS, 
will also be indicated on this form. Take-home instructions will be reviewed and 
provided at each treatment visit. 
To assist the research team in the ERT phone calls, education materials in the form of 
a local skin reaction guide with specific photos identifying the various skin reactions 
and examples of intensity will be reviewed at the clinic with the subject/guardian by 
the research team. Should a subject report experiencing excessive blistering or another 
adverse event needing physician assessment during the ERT call, they will be 
scheduled for an unplanned study visit and safety evaluation as soon as possible.  
Subjects 18 and older must provide consent as required by the IRB before any study 
procedures are conducted.  Parents or guardians must provide informed consent, and 
pediatric subjects older than 10 years must provide assent as required by the IRB before 

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any study procedures are conducted.  Subjects must meet all study eligibility criteria 
through a complete review of pertinent medical history, a dermatologic exam/lesion 
count and limited physical examination.  Full inclusion/exclusion criteria are provided 
in Section 2.2.  
2.2 
STUDY POPULATION 
250 subjects are expected to be enrolled and randomized into the VP-102-102 protocol 
(approximately 150 receiving VP-102 and 100 receiving placebo).  Eligibility to 
participate in the study will be determined by the investigator on the basis of the 
inclusion and exclusion criteria.  A second identically designed study is also anticipated 
to be conducted.   
2.2.1 
Inclusion Criteria 
To qualify for inclusion in this study, subjects must:  
1. 
Be healthy subjects, 2 years of age or older. 
2. 
Consent to having all molluscum lesions treated and the physician must be willing 
to treat all molluscum lesions initially present. (e.g., lesions within 10mm of the 
eyelid margins or the margin of any mucosal membrane should be evaluated 
carefully to ensure that they can be safely treated. Non-mucosal genital area lesions 
and inflamed lesions are considered treatable).  
3. 
Be otherwise medically healthy with no clinically significant medical history as 
determined by the investigator. Subjects exhibiting active Atopic Dermatitis may be 
enrolled. 
4. 
On day of treatment refrain from application of all topical agents including alcohol-
based sanitary products and sunscreens for a minimum of 4 hours before Study drug 
application. Topical agents including alcohol-based sanitary products and 
sunscreens may be used after application of the study drug so long as they are not 
applied within 5cm of treated skin lesions. 
5. 
Refrain from swimming, bathing or prolonged immersion in water until the Study 
drug is removed.  

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6. 
Have the ability or have a guardian with the ability to follow study instructions 
and be likely to complete all study requirements. 
7. 
Provide written informed consent or assent in a manner approved by the 
institutional review board (IRB) and/or have a parent/guardian provide written 
informed consent as evidenced by the signature on an IRB approved 
assent/consent form.   
8. 
Provide written authorization for use and disclosure of protected health 
information. 
9. 
Agree to allow photographs to be taken (selected sites only) of selected lesions at 
every visit that will be used for training, publications and marketing brochures. 
Photographs will be de-identified to those outside the research team.  Efforts will 
be made to ensure that no photographs with identifiable features are obtained. 
2.2.2 
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. 
Are systemically immunosuppressed or are receiving treatments such as 
chemotherapy or other non-topical immunosuppressive agents. 
3. 
Have any lesions present at baseline in anatomic locations that the subject/guardian 
or the physician is unwilling to treat. 
4. 
Have had any previous treatment of molluscum including the use of cantharidin, 
antivirals, retinoids, curettage or freezing of lesions in the past 14 days. Additional 
treatments should not be implemented during the course of the study. 
5. 
Have history of illness or any dermatologic disorder, which, in the opinion of the 
investigator will interfere with accurate counting of lesions or increase the risk of 
adverse events. 

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6. 
History or presence of a clinically significant medical, psychiatric, or emotional 
condition or abnormality which, in the opinion of the investigator, would 
compromise the safety of the subject or the quality of the data. 
7. 
Have a history or presence of hypersensitivity or an idiosyncratic reaction to the 
Study drug or related compounds, or drug product excipients (acetone, ethyl 
alcohol, nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian 
violet, and denatonium benzoate). 
8. 
Have a condition or situation that may interfere significantly with the subject’s 
participation in the study (e.g., subjects who required hospitalization in the 2 
months prior to screening for an acute or chronic condition including alcohol or 
drug abuse), at the discretion of the investigator. 
9. 
Have received another investigational product within 14 days prior to the first 
application of the Study drug. 
10. 
Have been treated within 14 days with a product that contains cantharidin (topical 
or homeopathic preparations) for any reason prior to screening. 
11. 
Are sexually active or may become sexually active and are unwilling to practice 
responsible birth control methods (e.g., combination of condoms and foam, birth 
control pills, intrauterine device, patch, shot and vaginal ring, etc.) Withdrawal is not 
an acceptable method of birth control.  Females who have reached menarche must 
have a negative urine pregnancy test at each visit prior to treatment with study drug. 
12. 
Are pregnant or breastfeeding. 
2.3 
ENDPOINTS 
Primary endpoint:  
 
• 
Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions 
(baseline and new) on the Day 84 visit (EOS).  
 
Secondary endpoints: 
• 
Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions 
(baseline and new) on the Day 63 visit.  

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• 
Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions 
(baseline and new) on the Day 42 visit.  
 
• 
Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions 
(baseline and new) on the Day 21 visit. 
 
Exploratory endpoints: 
 
• 
Change from baseline of the composite score from the Children’s Dermatology Life 
Quality Index (CDLQI) assessment at the EOS visit to measure the quality of life and 
impact of skin disease in the subset of subjects 4-16 years of age. 
 
• 
Percent reduction of all treatable molluscum lesions (baseline and new) from baseline at 
the EOS visit. 
 
• 
Change from baseline in the number of treatable molluscum lesions (baseline and new) at 
the EOS visit.  
 
• 
Proportion of subjects exhibiting a 75% or greater reduction of all treatable molluscum 
lesions (baseline and new) at the EOS visit. 
 
• 
Proportion of subjects exhibiting a 90% or greater reduction of all treatable molluscum 
lesions (baseline and new) at the EOS visit. 
 
• 
Subject reported spread to household members as measured by any new occurrence of 
molluscum in household members of subject. 
 
2.3.1 
Safety  
The following safety parameters will be assessed: 
• 
Limited physical examinations will be performed by a qualified medical 
practitioner at screening and at EOS visits.  Height and weight will be recorded 
at the screening visit and at the EOS visit.  Unscheduled physical examinations 
will be performed when clinically warranted (e.g., if a subject reports signs or 
symptoms requiring further evaluation). 
• 
Vital signs (e.g., heart rate and temperature) will be obtained at all treatment visits 
prior to treatment.  A final assessment of vital signs will be obtained at the EOS 
visit.  

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• 
If the subject discontinues the study prematurely (after the first treatment) for any 
reason, attempts will be made to encourage the subject/guardian to complete the 
EOS assessments.  At home assessments by a trained member of the study team 
may be considered in order to complete the EOS assessment. 
• 
Subjects will be monitored for signs and symptoms of AEs throughout the study.  
All AEs (including LSRs) will be reported in the electronic case report form 
(eCRF), including seriousness, severity, action taken, and relationship to the 
Study drug.  If AEs should occur, the first concern will be the safety of the subject.  
• 
Assessment of LSRs will be recorded at each Treatment Visit using the protocol 
specific ERT form.  Additional assessments will be conducted at 24-hours as well 
as day 7 and 14 after treatment either in person or by phone contact using the 
ERT form.  LSRs will be considered AEs even though some LSRs may be part 
of the normal response to treatment and correlated with efficacy. The following 
LSRs will be recorded: blistering, pain, pruritus, erythema, edema, 
erosion/ulcerations, flaking/scaling/dryness, scabbing/crusting, and pigmentation 
changes (hyperpigmentation or hypopigmentation).  These responses will be 
queried for duration and intensity.  Scarring will be evaluated in person by a 
qualified practitioner who is a trained member of the research team at in office 
treatment visits and the EOS visit. 
• 
Medical interventions taken throughout the course of the study prior to initial 
treatment, at 24-48 hours and 7, 14 and 21 days after treatment.  
2.3.2 
Efficacy  
Efficacy parameters will be recorded for all randomized subjects.  Clinical response to 
treatment of molluscum lesions will be evaluated at each scheduled visit until EOS by 
counting all treatable molluscum lesions. Untreatable lesions will be tracked and 
recorded. 
2.4 
RANDOMIZATION AND BLINDING 
Randomization through an interactive web response system (IWRS) will be used to 
assign treatment in a 3:2 ratio (expected 150 subjects treated with VP-102 to 100 
subjects treated with placebo).  Trial sites will have access to an internet-based 
randomization system.  Randomization will be conducted in a centralized manner. 

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Subjects with molluscum lesions present from the same household may be enrolled in 
the study. For ethical and practical considerations, subjects in the same household will 
be assigned to the same treatment group.   After a subject is randomized to a treatment, 
any other subject enrolled in the study from that household will be assigned the same 
randomization number and be given the same treatment.  As a result, the unit of 
randomization is the household- not the subject.  Randomizing by household at the site 
level could lead to strong differences from the desired treatment ratio at individual sites.  
Therefore, randomization by household will be carried out at the study level.  Since 
randomization is not done by site, analyses will not be stratified by site.     
If a medical emergency occurs and a decision about a subject’s condition requires 
knowledge of the treatment assignment, the investigator will contact the study assigned 
medical monitor at (919) 928-6780 to discuss the need and procedure for unblinding.  
The study blind may be broken for that specific subject only.  Any broken blind will be 
clearly justified and explained by a comment on the appropriate page of the case report 
form.  In addition, the investigator will immediately notify the medical monitor of the 
situation.  
In order to reduce possible functional unblinding and bias, blinded assessors will 
conduct lesion counts while separate trained members of the research team will conduct 
safety assessments and evaluations of response to treatment. A blinded assessor is a 
trained research team member that is not aware of a subject’s ongoing response to 
treatment. The blinded assessor’s role is to count and record the number of lesions at 
Treatment Visits 2, 3, 4 and EOS.  It is not required that the blinded assessor be the 
same person for each subject study visit.   
The Day 84 EOS visit will require a final assessment of ERT and confirmation of the 
presence or absence of molluscum lesions.  Each investigator conducting this final 
lesion count, must be a qualified member of the research team and will asked to 
complete an attestation to determine if they remain blinded as to the subject’s treatment 
group.  
REPLACEMENT OF DROPOUTS 

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Subjects who do not complete the EOS assessment will be considered dropouts.  
Subjects who are randomized in the study but never receive study drug will also be 
considered dropouts.  Dropouts will not be replaced. 
All randomized subjects will be evaluated in the intent-to-treat population. Those 
subjects who do not complete the full treatment due to lack of protocol adherence or 
who request to be discontinued from the study will be not be replaced.  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 will not be replaced.  Further discussion of how treatment failure 
will be utilized in analysis will be provided in the statistical analysis plan. 
If a subject subsequently becomes able to provide informed consent (turns of legal age 
while on study) or a legally authorized representative is located after randomization, 
information about the trial should be provided and procedures from the IRB/ethics 
committee will be followed.  The subject or legally authorized representative can 
withdraw consent at any time during the study and for any reason without any penalty 
or changes to care.  Data collected to the point that consent is withdrawn are still 
assessable by the principal investigator.  If subjects do not want their data that has 
already been submitted or collected specimens utilized, they will need to submit a 
request in writing to the Investigator for removal of their information. 

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3.0 
DRUGS AND DOSAGES 
3.1 
IDENTIFICATION AND DESCRIPTION OF INVESTIGATIONAL PRODUCT 
3.1.1 
Investigational Product 
VP-102 is a cantharidin solution [0.7% (w/v)] in a film-forming excipient formulation.  
The placebo contains all ingredients except cantharidin.  Once applied to the skin, 
solvents in the Study drug evaporate leaving behind a thin, flexible and resilient film.  
The Study drug is light violet to dark purple in color and has been manufactured under 
good manufacturing practices (GMP). 
VP-102 is manufactured in a GMP facility. The cantharidin used in VP-102 is more 
than 99% pure and manufactured under GMP. VP-102 is stable for at least 180 days 
when stored at controlled room temperature and out of direct light.  VP-102 is 
undergoing a GMP stability study and the stability date of this product may be updated 
in accordance with current FDA guidelines with appropriate data.  The Study drug will 
be released after passing quality control measures for description, uniformity of fill 
content, viscosity, assay, identification, impurities and microbial limits. Study drug is 
delivered in a single-use glass ampule stored within a single-use plastic applicator with 
integrated in-line filter to remove any glass particles capable of breaking the skin.  Each 
applicator is packaged in a tamper evident zip-top bag.  There are 5 applicators in each 
carton.   The IWRS system assigns one carton to each subject at the time of 
randomization.  Should a subject require more than 1 kit, the site will notify the Sponsor 
so that an additional Study kit may be assigned and a replacement kit obtained or 
shipped per study kit replenishment procedures.  
3.1.2 
Labeling 
An example of the label on Study drug single-use applicator packaging is presented in 
Figure 1.  The applicator will also display the appropriate standard flammable sign. 

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Figure 1. 
Clinical Trial Labeling of Study Drug  
 
Label on Applicator 
 
 
Label on Bag Around Each Applicator 
 
 
 

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Label on Carton  
 

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3.2 
DOSING INSTRUCTIONS AND SCHEDULE 
Upon activation, clinical sites will be provided with an initial supply of single-use 
applicators that each contains 450 µL of the Study drug (VP-102).  Each applicator can 
treat up to approximately 50 molluscum lesions.   
Following examination, all subjects will receive application of Study drug to all active 
molluscum lesions approximately every 21 days for a maximum of 4 applications.  
Please see the Instructions for Use (IFU), located in the accompanied Investigational 
Brochure for step-by-step instructions. 
Additional points to Consider: 
1. Given the length of time it may take to treat all lesions, investigators will assess in 
advance if subjects will be cooperative and able to sit still during the entire 
application of Study drug.  Application may not be conducted over more than 
1 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.  
2. Observe subjects for 5 minutes after Study drug application or until the film is 
formed and totally dry.  Subjects should confirm the study drug is completely dry 
prior to touching furniture with treated skin, putting on clothing and leaving the 
clinic.  It is important to prevent transference of the study drug to healthy areas of 
skin to minimize any potential and unnecessary reactions.  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 
24 hours after treatment or until the Study drug is removed.  Strongly urge 
subjects/guardians not to touch or wash the treated area for up to 24 hours.   
3. To remove the Study drug, the treated lesions should be washed with soap and 
warm water.  Subjects/guardians 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.  
Removal in the bath or shower is recommended, as simply wiping the treated 
lesions might not be sufficient for removal of the study drug. 

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4. Provide subjects/guardians with both verbal and the written take-home instructions 
on potential side effects and complications, contact information of the study 
investigator/study coordinator for questions or concerns, and a copy of their signed 
informed consent (Screening Day and/or Day 1 only).  Subjects will be provided a 
LSR guide to assist the Site in collecting the required ERT information related to 
the treated areas.  
5. Subjects should wash clothing, bedding and towels on a regular basis with hot water 
to minimize re-inoculation. Subjects are encouraged to wash their hands regularly 
with soap and water and discouraged from scratching lesions, which can spread 
disease. 
3.3 
STORAGE AND HANDLING OF INVESTIGATIONAL PRODUCT 
Study medication is packaged in subject-specific kits within cardboard boxes that 
contain 5 individually packaged applicators.  Each applicator is individually contained 
in a labeled zip-top bag.  The zip-top should not be opened until treatment is ready to 
be applied.  
The applicator is labeled with the Investigational New Drug (IND) application number 
and an applicator/kit number, which will be assigned to a specific subject. The label 
also indicates the date of manufacture and “Caution: New Drug--Limited by Federal 
Law to Investigational Use” and “Warning: Flammable Liquid.”  The applicator 
warnings indicate characteristics of the Study drug including the required labeling 
“Warning: Flammable Liquid” and the yellow toxic chemical symbol with the phrase 
“Warning: Highly Toxic”.  Used applicators are not to be discarded after use but should 
be returned to their zip-top bags and stored in the subject-specific carton until the study 
monitor completes accountability at the monitoring visit.  All used and unused study 
medication is to be discarded at the site in a sharps container, or per the site’s 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.  
Study drug must be stored at controlled room temperature (68°-77°F; excursions of 
59°-86°F are acceptable for short periods) 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 

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vehicle in a hot or cold environment).  Contact the study sponsor in the event 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. 
3.4 
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.   
Medications or treatments that can interfere with the evaluation of the Study drug 
[e.g., topical steroids, PDE-4 inhibitors (such as Eucrisa®), and calcineurin inhibitors 
(pimecrolimus, tacrolimus)] should not be used on the day of treatment and should not 
be applied within 5cm of treated skin lesions. Particular attention will be paid to 
treatments that can influence the intended effects or mask the side effects of the Study 
drug (e.g., topical steroids).  Lotions and creams such as sunscreens should not be used 
for a minimum of 4 hours before treatment and should not be applied within 5cm or on 
treated skin for 24 hours following treatment.  Immunizations and flu shots may be 
administered throughout the study but not within 5 days before or after treatment. 
 

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4.0 
EXPERIMENTAL PROCEDURES 
4.1 
OVERVIEW: SCHEDULE OF TIME AND EVENTS 
 
Each subject will be evaluated and treated as follows: 
1. Screening: (Up to 14 days prior to visit Day 1). 
2. Safety Evaluation: (Day 1: Treatment Visit 1) 
• 
Confirm that subject still meets all inclusion criteria and does not meet any 
exclusion criteria. 
• 
 Lesion count and CDLQI assessments. 
• 
Study drug application. 
• 
Removal of study drug 24 hours after application.  
• 
24-hour in-office ERT within 48 hours (+/- 1 day) after treatment and after 
medication has been removed. (AE’s, ConMeds) 
• 
ERT phone calls at 7 and 14 days after treatment. (AE’s, ConMeds) 
3. Safety and Efficacy Evaluation Period (Subjects may be scheduled 21+/- 4 days 
after treatment in the event of scheduling conflict. If possible, the next treatment or 
study visit should be scheduled 21 days from the day of the subject’s last treatment.) 
• 
Treatment 2: Lesion count by blinded assessor, dermatologic exam, CDLQI, ERT 
assessments and Study drug application (if subject has treatable lesions 
remaining). Removal of study drug 24 hours after application. ERT phone calls 
at 24 hours and Days 7 and 14 after treatment.  
• 
Treatment 3: Lesion count by blinded assessor, dermatologic exam, CDLQI, ERT 
assessments and Study drug application (if subject has treatable lesions 
remaining). Removal of study drug 24 hours after application. ERT phone calls 
at 24 hours and Days 7 and 14 after treatment. 
• 
Treatment 4: Lesion count by blinded assessor, dermatologic exam, CDLQI, ERT 
assessments and Study drug application (if subject has treatable lesions 

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remaining). Removal of study drug 24 hours after application. ERT phone calls 
at 24 hours and Days 7 and 14 after treatment. 
4.  End of Study: (targeted 21 days after Treatment Visit 4)  
• 
Lesion count by blinded assessor, dermatologic exam, CDLQI and ERT 
assessments.  
The Screening period permits screening up to 14 days prior to Treatment Visit 1.  An 
IRB-approved Informed Consent and Assent (assent when applicable) will be signed 
before any study specific procedures are performed.  The Safety Evaluation Period 
(Treatment Visit 1) will begin with confirmation that the subject still meets study 
criteria (e.g., Dermatologic exam/lesion count; ability to attend study visits).  After the 
screening/enrollment study activities have been completed, all safety assessments must 
be completed by a qualified member of the research team who is not utilized as a 
blinded assessor for an individual subject’s efficacy assessments.  Lesion counts will 
be performed at each treatment visit by a blinded assessor prior to each treatment 
application. It is not required that the blinded assessor be the same person for each 
study visit. 
Subject impact on quality of life will be assessed using the CDLQI during each 
treatment visit, prior to the application of Study drug.  ERT in-person safety 
assessments will be conducted during the initial treatment visit and within 48 hours 
after the initial treatment application (and must be after Study drug has been removed).  
Subsequent safety follow-ups will include ERT phone assessments at 24 hours, 7 and 
14 days after each treatment. ERT will also be assessed at each 21-day in person visit 
prior to Study drug application.  During the Safety and Efficacy Evaluation Period, 
subjects will be scheduled every 21 days (+/- 4 days); in the event that there are 
scheduling conflicts preventing a 21-day return visit, the next treatment will be 
scheduled at 21 days after the last treatment.   In the event a subject misses a treatment 
visit and is outside the study window, they may return and be treated at the next 
available opportunity with the subsequent visit scheduled 21 days after treatment to 
facilitate up to 4 treatments within 84 Days.  The final study visit assessment must be 
completed on or before Day 100. Subjects who are not assessed as 100% cleared of all 
treatable lesions at the EOS visit will have completed the study and will be further 
treated per standard of care at their physician’s discretion.  AEs will be assessed at 
every study visit.  
 

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4.2 
MEASUREMENTS AND EVALUATIONS 
 
4.2.1 
Screening Period (Up to 14 days prior to Treatment Visit 1) 
Before the initiation of screening assessments, the subject/guardian must be given a 
complete explanation of the purpose and evaluations of the study.  Subsequently and 
depending on the age of the subject, the subject/guardian  must sign and receive a copy 
of an informed consent form (ICF) (Section 7.3), an IRB-required assent form (subjects 
10 years or older), and an authorization for use and disclosure of protected health 
information (Section 7.3) that was approved by the IRB.  Once consent and assent 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.  Following 
consent and assent, review and recording of any medical history will take place, and 
the following evaluations will be performed and recorded in the electronic case report 
form (eCRF): 
1. 
Demographics (date of birth, sex, ethnic origin).  
2. 
Height and weight 
3. 
Prior relevant medical history 
a. All past relevant illnesses with in the past 5 years. 
b. All drugs used (including non-prescription and herbal [complementary 
medicine] products) within 14 days prior to screening procedures.  Any 
anti-microbial, anti-viral, steroidal or topical drugs received within 30 days 
prior to Day 1. 
c. Any non-pharmacologic treatments (e.g., ice packs, heat packs, warm soaks, 
etc.) administered in the 72 hours prior to the application of the Study drug. 
4. 
Molluscum contagiosum history (duration and previous treatments).  If treated 
with cantharidin, confirm date of last treatment. 
5. 
Limited physical examination. 

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4.2.2 
Safety Evaluation Period (Treatment Visit 1)  
Screening and Treatment Visit 1 may occur on the same day.  The following 
evaluations will be performed and recorded in the electronic case report form (eCRF): 
1. 
Confirmation that the inclusion/exclusion criteria are met. 
2. 
Dermatologic exam: 
a. Regional molluscum lesion count (head/neck, chest/abdomen, back/buttocks, 
groin, and upper/lower extremities) including treated and untreated lesions.  
b. Presence of any confounding dermatologic diseases such as atopic dermatitis. 
3. 
Medical history to assess any changes since screening (as described in Section 
4.2.1). 
4. 
Review and recording of any concomitant medications and non-pharmacologic 
treatments or procedures in the last 14 Days prior to enrollment and since the last 
study visit. 
5. 
The presence of household members with molluscum.  If these household 
members are enrolled in the study and if so the household member’s subject ID 
number. 
6. 
Vital signs (heart rate and temperature). 
7. 
Limited physical examination. 
8. 
CDLQI assessment. 
9. 
Urine pregnancy test for females of child-bearing potential, defined as capable of 
menstruating, to determine protocol eligibility.   
10. ERT assessment (LSRs, AEs, ConMeds)-prior to treatment. 
11. Photographs taken before application of the Study drug (at selected sites only). 
12. Application of Study drug. 

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13. Subjects will be given take-home instructions describing potential local skin 
reactions and what they might expect throughout the course of the study, as well 
as recommendations for wound care, when it is important to call their doctor and 
instructions for who to contact in an emergency.  
14. A local skin reaction guide for subjects with specific photos identifying the 
various skin reactions and examples of intensity will be reviewed at the clinic 
with the subject/guardian by the research team. Should a subject report 
experiencing excessive blistering or another adverse event needing physician 
assessment, they will be scheduled for an unplanned study visit and safety 
evaluation at the next available opportunity.   
15. Review and record any AEs and concomitant medications.  
16. Depending on age of subject, subject or parent/guardian will wash off the Study 
drug with warm water at 24 hours after application of Study drug.  
Subjects/guardians may gently remove the Study drug from lesions without the 
use of a washcloth in problematic areas prior to the directed 24 hours if the lesions 
have already blistered or if the subject is experiencing significant pain. Study drug 
should not be removed from the additional lesions, where possible, unless 
significant blistering occurs or the 24-hour time point is reached, whichever 
comes first.  
17. A 24-hour in-person follow-up visit will be conducted within 48 hours (+/- 1 day) 
following the initial treatment. Study drug must have been removed before the 
actual visit.  Additional ERT assessments will be conducted over the phone at 7 
and 14 days after treatment. 
 
4.2.3 
Safety and Efficacy Evaluation Period: (Treatment Visits 2, 3 and 4)  
1. 
Review and recording of any concomitant medications and non-pharmacologic 
treatments/procedures since previous visit. 
2. 
Review and recording of any AEs (before and after Study drug application). 
3. 
Vital signs (heart rate and temperature) before Study drug application. 

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4. 
Dermatologic exam (as described in Section 4.2.1) with counting of molluscum 
lesions. Lesion counts must be conducted and documented by a blinded assessor 
who is not familiar with the subject’s safety assessments or response to treatment. 
5. 
CDLQI assessment. 
6. 
ERT assessment (LSRs, AEs, ConMeds)-prior to treatment. (May not be 
conducted by a research team member who is utilized as the subject’s blinded 
assessor) 
7. 
Urine pregnancy test for females of child-bearing potential to confirm continued 
protocol eligibility before application of study drug.   
8. 
Photographs taken before application of the Study drug (selected sites only). 
9. 
 Administration of study drug to all lesions including those lesions that may be 
newly developed.  If any new lesions are not treatable, this will be documented 
by the team member who is applying the treatment. 
10. Subjects will be given take-home instructions describing the potential local skin 
reactions and what to expect over the next 24 hours to several months.   
11. Post treatment safety evaluations will be conducted by the research team via 
phone calls at 24 hours and days 7 and 14 after every treatment application (ERT). 
The phone call will review questions related to removal of Study drug, and review 
and documentation of local skin reactions, adverse events and con-meds since the 
prior visit or call. Phone calls may not be conducted by a research team member 
utilized as the subject’s  blinded assessor. 
12. Depending on the age of the subject, the subject/guardian will wash off the Study 
drug 24 hours after application of Study drug.  Subjects/guardian may gently 
remove the Study drug from lesions without the use of a washcloth in problematic 
areas prior to the directed 24 hours if the lesions have already blistered or if the 
subject is experiencing significant pain. Study drug should not be removed from 
the additional lesions, where possible, until the expected blistering occurs or the 
24-hour time point is reached, whichever comes first. 

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4.2.4 
End of Study (Day 84): 
Subjects will return to the clinical site for: 
1. 
Review and recording of any concomitant medications and non-pharmacologic 
treatments/procedures since previous visit.   
2. 
Review and recording of any AEs. 
3. 
Vital signs (heart rate and temperature) obtained at the beginning of visit. 
4. 
Limited physical examination. 
5. 
Lesions counted and recorded by blinded assessor.  
6. 
CDLQI assessment 
7. 
Dermatologic exam, ERT assessment (LSRs, AEs, ConMeds) (conducted by 
qualified member of the research team who is not utilized as a subject’s blinded 
assessor. 
8. 
Urine pregnancy test for females of childbearing potential. 
9. 
Photographs (at selected sites only). 
5.0 
PROCEDURES FOR HANDLING ADVERSE EVENTS AND SERIOUS 
ADVERSE EVENTS 
5.1 
DEFINITION OF AN ADVERSE EVENT 
The following definition of adverse event (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.   
The following are examples of AEs: 

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• 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)? 
• Development of individual blisters that are greater than 20mm in diameter (the 
diameter of a dime). (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 preexisting 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 once 
the subject has signed informed consent and will continue until the EOS visit has been 
completed. 
The investigator is responsible for performing periodic and special assessments for 
AEs.  The investigator and study personnel will note all AEs mentioned by the subject 
starting from the day the informed consent is signed until the end of study visit (~Day 
84).  All clinical complaints volunteered by or elicited from the subject or 
parent/guardian during the study will be recorded on the appropriate page of the eCRF 
for the study period indicated.  The subject will receive appropriate treatment and 
medical supervision for any AE that occurs.   
All unresolved AEs will be followed for 30 days after study completion.  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 5.3.   

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5.2 
DEFINITION OF A SERIOUS ADVERSE EVENT 
In this study, a serious adverse event 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. 
• 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. 
• Other 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 

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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. 
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 Investigator’s 
Brochure).  
5.3 
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, etc.) 
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. 
 
 

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5.4 
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 2 should be used in assigning intensity of each AE recorded 
in the eCRF. 
Table 2 
Classification of AEs 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 5.2. 
Local Skin Reactions should be rated based on the severity ratings in the Local Skin 
Reaction Guide that is provided. 
5.5 
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 

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investigational product.  The investigator will also consult the Investigator’s Brochure 
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 3. 
Table 3 
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. 
 
 
 
5.6 
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 Investigator’s Brochure.  The 
expectedness of an SAE will be assessed by the medical monitor or sponsor on receipt 
of the initial SAE report. 

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5.7 
REPORTING OF SERIOUS ADVERSE EVENTS 
Any SAE occurring after the subject signs the informed consent form must be reported 
to the Sponsor or designee by phone, or e-mail within 24 hours of the time the 
investigator becomes aware of the SAE (Table ). Urgent reporting of SAEs is required 
for the following reasons: 
1. To enable the Sponsor to fulfill the reporting requirements to the appropriate 
regulatory authority 
2. To facilitate discussion between the Sponsor and the investigator about appropriate 
follow-up measures (if necessary) 
3. To facilitate the Sponsor’s rapid dissemination of information about AEs to other 
investigators or sites in a multicenter study 
4. To facilitate reporting unanticipated problems involving risk to subjects to the IRB  
Table 4 
Timeline for Reporting SAEs 
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. 
 
 
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 knowledge of a new SAE, the investigative site will enter the event 
as an SAE into the EDC system being used for this study and recorded into the safety 
module. The SAE report should include the essential elements.   

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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 via the SAE Hotline of the 
SAE.  The SAE report form will be updated by the investigator when additional 
information is received.  
New SAEs, or follow-up SAE information, may be reported to the Paidion Research 
Medical Monitor (Laurie Dunn, MD) by calling the SAE Hotline at (919) 928-6780.  
The SAE Hotline may be accessed 24 hours/day, 7 days/week.  The Hotline is 
monitored 24 hours/day, 7 days/week.  A call to the SAE Hotline is not required and 
does not alleviate the Investigator of the responsibility to report a new SAE in the EDC 
system within 24 hours of knowledge. 
5.8 
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 end of study (EOS visit). 
The appropriate SAE report form will be updated in the EDC once 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). 
5.9 
PREGNANCY 
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. 

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6.0 
STUDY OR SITE TERMINATION AND SUBJECT DISCONTINUATION 
6.1 
SUBJECT DISCONTINUATION 
Subjects are encouraged to complete the study; however, they may voluntarily 
withdraw at any time.  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 eCRF page.  If a subject withdraws before completion, every effort 
should be made to complete the Day 84 assessments scheduled during the End of Study 
visit.  Should a subject be unable to complete the in-office EOS evaluation by Day 100, 
if available, they may be given the option of an in-home assessment by a qualified 
member of the research team. 
A subject may be removed from the study for the reasons described in Section 6.1.1 
through Section 6.1.5. 
6.1.1 
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. 
6.1.2 
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. 
6.1.3 
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 3.0 

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• Failure to comply with protocol requirements 
6.1.4 
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. 
6.1.5 
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 
eCRF page.  If subjects do not want their data that has already been submitted or 
specimens utilized they will need to submit a request in writing to the Investigator for 
removal of their information.  
6.2 
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 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 
A study conducted at a single site in a multicenter study may also warrant termination 
under the following conditions: 
• Failure of the investigator to enroll subjects into the study at an acceptable rate 

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• 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 E6, Guideline for Good Clinical Practice. 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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7.0 
DATA COLLECTION AND PROCESSING AND STATISTICAL ANALYSIS 
7.1 
DATA COLLECTION AND PROCESSING  
Electronic case report forms (eCRFs) will be used to capture study assessments and 
data.  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.  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.  Once 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 electronic data capture (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 standard operating 
procedure (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 
(user ID) and password before any data can be entered in the eCRFs.  Authorized study 
personnel will be assigned a unique user ID 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 7.4. 

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7.2 
STATISTICAL ANALYSIS 
7.2.1 
General Overview 
Subject disposition, demographics, baseline characteristics and study drug exposure 
will be summarized by treatment group.  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.  
All statistical analyses will be performed and data appendices will be created by using 
SAS version 9.3 or higher.  All statistical tests will be two-sided at the α = .05 level. 
7.2.2 
Populations of Interest 
The intent-to-treat population (ITT) will include all subjects randomized to either 
placebo or VP-102. 
Subjects who receive all 4 planned treatments of VP-102/Placebo and have no major 
protocol violations will be included in the Per Protocol population.  The following pre-
determined reasons will exclude subjects from being included in the Per Protocol 
population: 
• Subjects treated with the incorrect study drug. 
• Subjects who do not come in for required treatment visits. 
• Subjects who refuse to have all of their treatable lesions treated or 
investigators who refuse to treat all treatable lesions. 
• Early removal of the study drug not associated with pain, blistering or 
other medically appropriate reason for early removal. 
• Subjects with missing lesion counts or clearance assessments. 
• Subjects who begin alternative treatments for their molluscum after 
starting the study. 
• Subjects enrolled who did not meet the inclusion/exclusion criteria. 
• Subjects whom have their blind broken as to their treatment group without 
following study procedures. 
 
The safety population will include randomized subjects who meet the screening 
eligibility criteria for the study and receive at least one treatment of VP-102 or placebo. 

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7.2.3 
Efficacy Analysis 
Efficacy analysis using the ITT population will be considered the primary analysis.  
Analysis carried out on the per protocol population will be considered secondary in 
nature.  Efficacy analysis carried out on the ITT and per protocol populations will be 
based on the treatment the subject was randomized to. 
The primary endpoint of proportion of subjects exhibiting clearance of all treatable 
lesions (baseline and new) at the Day 84 (EOS) visit will be analyzed.  Treatment 
difference in clearance rates will be tested with a Pearson Chi-Square test. Other binary 
endpoints, including clearance at Day 63, clearance at Day 42 and clearance at Day 21, 
spread to household members and 75% and 90% reduction of treatable lesion count, 
will also be analyzed with this method. 
Continuous endpoints: percent change in treatable lesion count from baseline, change 
in treatable lesion count from baseline, change in CDLQI assessment from baseline 
will be analyzed with an ANCOVA model to test for treatment differences at EOS.  For 
the ANCOVA model, the independent variable will include treatment.  A covariate of 
baseline lesion count will be included.  Further details of analyses of other endpoints 
will be provided in the statistical analysis plan.   
Though the analysis will not be stratified by site, an assessment of the results across 
sites will be performed.  A Breslow Day test will be performed to consider any potential 
site-to-site variability of study results. A site with a strong deviation in treatment effect 
from other sites will be further investigated to try to gain a better understanding of why 
differences at the site may exist. 
Sequential testing will be used to control the overall study-wise alpha. If the primary 
endpoint is significant, testing of the secondary endpoints in the order specified in the 
statistical analysis plan will continue. If any hypothesis test fails to reach statistical 
significance, then testing will cease for confirmatory purposes.  
7.2.4 
Safety Analysis 
Safety analysis will be based on the safety population.  Subjects will be assigned to the 
treatment received for any analysis of safety. 

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Adverse event data for the safety population will be listed individually, and the 
incidence of adverse events will be summarized by treatment, System Organ Class, and 
Preferred Term using frequency counts.  Local skin reactions will be included as part 
of the overall adverse event summaries.  Adverse events will be tabulated by total rate 
of occurrence and rate of severe occurrences.  When calculating the incidence of 
adverse events, only Treatment Emergent Adverse Events (TEAEs) will be considered.  
In addition, any adverse event with an onset date after the EOS visit will be considered 
off study and will not be included in tables summaries (though they will appear in 
adverse event listings).  Each adverse event will be counted only once for a given 
subject.  If the same adverse event 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 adverse events are reported as a unit, the individual terms will be reported 
as separate events.  Changes in vital signs, from baseline to the end of the study will be 
examined.  Treatment-emergent changes from normal values to abnormal values will 
be identified as described in Section 2.3.1.   
In addition, separate summaries of local skin reactions (LSRs) will be generated.  
Investigator and subject reported LSRs will be displayed by treatment, severity, 
causality, time (treatment visit) and body region. 
7.2.5 
Interim Analysis 
No interim analysis is planned for this study. 
7.2.6 
Sample Size 
The sample size for the study is calculated based on hypotheses of the primary efficacy 
endpoint.  The primary endpoint for this study is the proportion of subjects with 
complete clearance of all treatable lesions (baseline and new) after treatment.  The 
statistical hypotheses for the primary endpoint are: 
HO: The proportion of subjects exhibiting complete clearance of all treatable 
molluscum lesions (baseline and new) at the EOS visit is equal when 
comparing the subjects treated with VP-102 vs. the subjects treated with 
placebo. 

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Ha: The proportion of subjects exhibiting complete clearance of all treatable 
molluscum lesions (baseline and new) at the EOS visit is different when 
comparing the subjects treated with VP-102 vs. the subjects treated with 
placebo. 
The study is expected to enroll and randomize 250 subjects in the VP-102-102 protocol 
with molluscum lesions to test for treatment differences in the rate of complete 
clearance.  Subjects will be randomized and treated in a double-blind manner with 
either VP-102 or placebo in a 3:2 ratio (approximately 150 subjects on VP-102 to 100 
subjects on placebo).  
 
 
Study assumptions include the following: 
 
• a 10% drop out rate. 
•  a 20% clearance rate for subjects treated with placebo.  This is based on reported 
placebo treated clearance rates for placebo controlled studies, such as Aldara (26% 
clearance at 18 weeks, adjusted to Verrica’s 12-week study) and several other placebo 
studies suggesting a similar clearance rate including Short, 2006, Syed 1995, Dosal 
2012, Burke 2004 and Theos 2004. 
•  a 44% clearance rate for subjects treated with VP-102.  This is based on a calculated 
clearance rate of 44% (11 cleared out of 25 completed subjects in NCT03017846.   
 
Using these assumptions, a sample size of 250 subjects based on a Pearson Chi-Square 
test with a two-sided significance level of 0.05 will give >=95% power to detect 
treatment differences in clearance rates. 
 
7.2.7 
Handling of Missing Data 
Clearance of all treatable lesions is to be assessed a maximum of four times during the 
study.  Assessments are to be done at Day 21, Day 42, Day 63 and Day 84 (EOS). The 
assessment done at Day 84 is considered to be the primary efficacy endpoint.   
Subjects who do not have an assessment of complete clearance of all treatable lesions 
at 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 

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complete clearance data as not having achieved complete clearance.  It is assumed that 
the proportion of subjects with missing data will be greater for subjects treated with 
VP-102 than subjects treated with placebo.  This is because subjects treated with VP-
102 are assumed to be more likely to clear prior to Day 84; meaning they will be less 
likely to return for their Day 84 (EOS) visit.  Under this condition, one would expect 
there to be less chance to detect treatment differences (conservative approach).  Rates 
of subjects with missing data of the primary endpoint will be compared by treatment 
group.  Significant deviations in rates of subjects with missing data that may affect 
study conclusions will be included in the study report. 
Sensitivity analyses of primary endpoint using the ITT population are based on ICH 
Guideline E9 [25] and will include the following: 
• Analysis using only non-imputed data (complete case analysis); 
• Analysis in which all subjects with missing data are assigned as having 
achieved complete clearance; 
• Analysis in which subjects with missing data and treated with placebo are 
considered to have complete clearance; subjects with missing data and treated 
with VP-102 are considered to not have complete clearance (worst case 
analysis). 
One additional set of analyses of the primary endpoint will be generated using the per 
protocol population. 
The CDLQI assessment is validated for subjects 4 to 16 years and old.  However, 
subjects 2 and 3 years old are allowed to be enrolled in the study as well as subjects 
older than 16.  One planned set of sensitivity analysis for CDLQI will be to test for 
treatment differences of the composite CDLQI score using all subjects enrolled, rather 
than the subset of subjects 4-16 years of age.  Results using all subjects enrolled will 
be compared to the exploratory endpoint using only those subjects 4-16 years of age. 
The procedures for handling missing data and associated sensitivity analysis for other 
study endpoints will be described in the statistical analysis plan. 
 

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7.3 
INFORMED CONSENT/ASSENT AND AUTHORIZATION FOR USE AND 
DISCLOSURE OF PROTECTED HEALTH INFORMATION  
Written assent and informed consent and authorization of use and disclosure of 
protected health information must be obtained from each subject (or the subject’s 
legally 
acceptable 
representative) 
before 
performing 
any 
study-specific 
screening/baseline period evaluations.  One copy of the signed informed consent form 
(and IRB-required assent form) and authorization for use and disclosure of protected 
health information form will be given to the subject, and the investigator will retain the 
original.  The informed consent/assent form 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 informed consent form must contain the 20 elements of informed 
consent described in International Council for Harmonisation 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.  
7.4 
STUDY DOCUMENTATION 
7.4.1 
Investigator Information 
Investigator information is included in the Study Procedures Manual, which is updated 
as needed. 
7.4.2 
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 Investigator’s Brochure, the clinical 
protocol and amendments, safety information, information about investigational 
product, the study procedures manual and 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. 

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7.4.3 
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.  
7.4.4 
Retention of Study Documents 
According to International Council for Harmonisation 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 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. 

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7.5 
CONFIDENTIALITY 
7.5.1 
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).  
7.5.2 
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 informed 
consent form) 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. 
7.6 
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 informed consent form and assent form, the revised 
informed consent and assent forms 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 

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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.  
7.7 
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 
International Council for Harmonisation E6 guidance. 
7.8 
GENERAL INFORMATION 
The investigator should refer to the Investigator’s Brochure, study procedures manual, 
and any other information provided about this investigational product and details of the 
procedures to be followed during this study. 

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8.0 
REFERENCES 
1. 
American Academy of Pediatrics. Molluscum contagiosum. In: Red Book: 
2009 Report of the Committee on Infectious Diseases.   28th ed Edition, Elk 
Grove Village, IL.  2009:466-467. 
2. 
Piggott C. Poxvirus infections. In: Fitzpatrick's Dermatology in General 
Medicine.  Goldman LA ed. Vol 2,  8th Edition, New York. McGraw-Hill, 
2012:2402-2420. 
3. 
Olsen JR, Gallacher J, Finlay AY, Piguet V, Francis NA. Time to resolution 
and effect on quality of life of molluscum contagiosum in children in the UK: 
a prospective community cohort study. Lancet Infect Dis 2015;15(2):190-195. 
4. 
Olsen JR, Gallacher J, Piguet V, Francis NA. Epidemiology of molluscum 
contagiosum in children: a systematic review. Fam Pract 2014;31(2):130-136. 
5. 
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. 
6. 
Bonness K, Aragon IV, Rutland B, Ofori-Acquah S, Dean NM, Honkanen RE. 
Cantharidin-induced mitotic arrest is associated with the formation of aberrant 
mitotic spindles and lagging chromosomes resulting, in part, from the 
suppression of PP2Aalpha. Mol Cancer Ther 2006;5(11):2727-2736. 
7. 
Kuo JH, Chu YL, Yang JS, Lin JP, Lai KC, Kuo HM, et al. Cantharidin induces 
apoptosis in human bladder cancer TSGH 8301 cells through mitochondria-
dependent signal pathways. Int J Oncol 2010;37(5):1243-1250. 
8. 
Boris A, Hurley JF. Assessment of topical anti-inflammatory activity in rats 
with cantharidin-induced inflammation. J Invest Dermatol 1977;68(3):161-164. 
9. 
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. 

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10. 
Rabkin SW, Friesen JM, Ferris JA, Fung HY. A model of cardiac arrhythmias 
and sudden death: cantharidin-induced toxic cardiomyopathy. J Pharmacol Exp 
Ther 1979;210(1):43-50. 
11. 
Neumann J, Herzig S, Boknik P, Apel M, Kaspareit G, Schmitz W, et al. On 
the cardiac contractile, biochemical and electrophysiological effects of 
cantharidin, a phosphatase inhibitor. J Pharmacol Exp Ther 1995;274(1):530-
539. 
12. 
Linck B, Boknik P, Knapp J, Muller FU, Neumann J, Schmitz W, et al. Effects 
of cantharidin on force of contraction and phosphatase activity in nonfailing 
and failing human hearts. Br J Pharmacol 1996;119(3):545-550. 
13. 
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. 
14. 
Hong SJ. Inhibition of mouse neuromuscular transmission and contractile 
function by okadaic acid and cantharidin. Br J Pharmacol 2000;130(6):1211-
1218. 
15. 
Knapp J, Boknik P, Huke S, Gombosova I, Linck B, Luss H, et al. Contractility 
and inhibition of protein phosphatases by cantharidin. Gen Pharmacol 
1998;31(5):729-733. 
16. 
Schairer DO. Interim analysis of a double-blind, placebo-controlled study of 
topical cantharidin for the treatment of molluscum contagiosum. Pediatr 
Dermatol 2015;32:758. 
17. 
Dosal C, Stewart PW, Lin JA, Williams CS, Morrell DS. Cantharidin for the 
treatment of molluscum contagiosum: a prospective, double-blinded, placebo-
controlled trial. Pediatr Dermatol 2014;31(4):440-449. 
18. 
The British Pharmaceutical Codex. General Monographs. Cantharidin.  1949: 
2010. 

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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. 
Cathcart S, Coloe J, Morrell DS. Parental satisfaction, efficacy, and adverse 
events in 54 subjects treated with cantharidin for molluscum contagiosum 
infection. Clin Pediatr (Phila) 2009;48(2):161-165. 
22. 
Silverberg NB, Sidbury R, Mancini AJ. Childhood molluscum contagiosum: 
experience with cantharidin therapy in 300 subjects. J Am Acad Dermatol 
2000;43(3):503-507. 
23. 
Hanna D, Hatami A, Powell J, Marcoux D, Maari C, Savard P, et al. A 
prospective randomized trial comparing the efficacy and adverse effects of four 
recognized treatments of molluscum contagiosum in children. Pediatr Dermatol 
2006;23(6):574-579. 
24. 
Funt TR. Cantharidin treatment of molluscum contagiosum. Arch Dermatol 
1961;83:504-505. 
25. 
European Medicines Agency. Guideline on missing data in confirmatory 
clinical 
trials. 
 
2010. 
 
www.ema.europa.eu/doc/en 
GB/document 
library/Scientific guideline/2010/09/WC500096793.pdf. 
26.  
Connell JR, Duncan SJ. The effect of non-phorbol promoters as compared with 
phorbol myristate acetate on sister chromatid exchange induction in cultured 
Chinese hamster cells. Cancer Lett 1981;11(4):351-356. 
27.  
Lewis-Jones MS, Finlay AY. The Children’s Dermatology Life Quality Index 
(CDLQI): Initial validation and practical use. British Journal of Dermatology, 
1995; 132: 942-949. 

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8.1 
UNPUBLISHED MANUSCRIPT 
Garelik J, Schairer D, Hwang H, Viola K, Cohen S. Safety and efficacy of topical 
cantharidin for the treatment of pediatric molluscum contagiosum: a prospective, 
randomized, double-blind, placebo-controlled trial. 

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APPENDICES

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APPENDIX 1 
 
 
CHILDREN’S DERMATOLOGY LIFE QUALITY INDEX SCORING INSTRUCTIONS

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APPENDIX 1 
Children’s Dermatology Life Quality Index Scoring Instructions [27]   
Subjects and their guardians will be instructed to fill out the CDLQI as it relates to molluscum and 
not other concomitant skin diseases. 
The scoring of each question of the CDLQI is as follows: 
Very much 
scored 3 
Quite a lot 
scored 2 
Only a little 
scored 1 
Not at all 
scored 0 
Question unanswered 
scored 0 
Question 7: “Prevented school” scored 3 
  
 
The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 
and a minimum of 0.  The higher the score, the more quality of life is impaired.  
Interpretation of incorrectly completed questionnaires: 
1. If one question is left unanswered this is scored 0 and the scores are summed and expressed 
as usual out of a maximum of 30. 
2. If two or more questions are left unanswered the questionnaire is not scored. 
3. If both parts of question 7 are completed the higher of the two scores should be counted. 
 
 

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APPENDIX 2 
 
 
VERSION HISTORY AND SUMMARY OF CHANGES

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APPENDIX 2 
Version history: 
DOCUMENT 
VERSION 
DATE 
Protocol VP-102-102 
1 
24 February 2017 
Protocol VP-102-102 
2 
31 July 2017 
Protocol VP-102-102 
3 
29 September 2017 
Protocol VP-102-102 
4 
05 December 2017 
Protocol VP-102-102 
5 
01 February 2018 
 
Summary of changes to Protocol VP-102-102 (revised 01 February 2018):  
SECTIONS/PAGES CHANGED 
DESCRIPTION OF CHANGES 
Cover pages: 
 Changes to Sponsor contact information and address.  
Synopsis:   
Objectives: Page 4 
 
Main Protocol:  
1.6 Secondary Objectives: Page 29, 30 
 
Secondary Objectives updated to remove 2 objectives and now reads 
as follows:  
• 
to assess the safety and tolerability of VP-102, when applied once 
every 21 days for up to 4 applications, to treatable molluscum 
lesions on subjects 2 years old and older by assessing adverse 
events including expected local skin reactions, physical 
examinations, and concomitant medications at End of Study 
compared to baseline.  
• 
to evaluate the efficacy of VP-102 relative to placebo by assessing 
the proportion of subjects achieving complete clearance of all 
treatable molluscum lesions at Visit 2. Separate assessments for 
clearance will be repeated for both Visit 3 and Visit 4 
 
Synopsis:  
Secondary and Exploratory Endpoints: Page 
8 
 
Main Protocol:  
2.3 Endpoints: Page 36 
Updated to move the CDLQI from the secondary endpoints to the 
exploratory endpoints. 
Main Protocol: 
2.4 Randomization and Blinding: Page 38 
Randomization through an interactive web response system (IWRS) 
will be used to assign subjects treatment in a 3:2 ratio (expected 150 
subjects treated with VP-102 to 100 subjects treated with placebo).  
Trial sites will have access to an internet-based randomization system.  
Randomization will be conducted in a centralized manner. Subjects 
with molluscum lesions present from the same household may be 
enrolled in the study. For ethical and practical considerations, subjects 
in the same household will be assigned to the same treatment group.   
After a subject is randomized to a treatment, any other subject 
enrolled in the study from that household will be assigned the same 
randomization number and be given the same treatment.  As a result, 
the unit of randomization is the household- not the subject.  

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Randomizing by household at the site level could lead to strong 
differences from the desired treatment ratio at individual sites.  
Therefore, randomization by household will be carried out at the 
study level.  Since randomization is not done by site, analyses will not 
be stratified by site.     
Synopsis:  
Statistical Methods: Page 10, 11 
 
Main Protocol: 
7.2 Statistical Analysis: Page 67, 68 
 
Updated to reflect changes in types of analysis to be conducted. 
Updated to indicate that the Breslow Day test will be performed to 
consider any potential site-to-site variability of study results. 
Main Protocol: 
7.2.4 Safety Analysis: Page 68 
Updated to clarify that separate summaries of local skin reactions 
(LSRs) will be generated.  Investigator and subject reported LSRs will 
be displayed by treatment, severity, causality, time (treatment visit) 
and body region.