Randomized, Double-Masked, Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation
Phase: PHASE2
Conditions: Meibomian Gland Dysfunction, Blepharitis, Demodex Infestation
Sponsor: Tarsus Pharmaceuticals, Inc.

NCT05454956

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TABLE OF CONTENTS 
1. 
ABBREVIATION TABLE ..........................................................................................7 
2. 
INTRODUCTION AND RATIONALE .....................................................................8 
2.1. 
MEIBOMIAN GLANDS ...............................................................................................8 
2.2. 
MEIBOMIAN GLAND DYSFUNCTION ....................................................................8 
 
 
 
 
 
 
2.6. 
POTENTIAL RISKS AND BENEFITS ......................................................................13 
3. 
TREATMENTS..........................................................................................................14 
3.1. 
TP-03 AND VEHICLE ................................................................................................14 
4. 
STUDY OBJECTIVE ................................................................................................15 
5. 
STUDY DESIGN ........................................................................................................15 
6. 
STUDY POPULATION ............................................................................................15 
7. 
STUDY OUTCOME MEASUREMENTS ...............................................................18 
7.1. 
EFFICACY PARAMETERS .......................................................................................18 
7.2. 
SAFETY PARAMETERS ...........................................................................................18 
8. 
CLINICAL EVALUATIONS ...................................................................................18 
8.1. 
DAY 1 ..........................................................................................................................18 
8.2. 
DAYS 15 (±4 DAYS) AND 29 (±5 DAYS) ...............................................................19 
8.3. 
DAY 43 (-7/+6 DAYS) AND DAY 57 (-7/+10 DAYS) .............................................20 
8.4. 
DAY 85 (-13/+7 DAYS) ..............................................................................................20 
8.5. 
DAY 115 (+60 DAYS) ................................................................................................21 
9. 
STUDY DRUG ...........................................................................................................21 
10. 
STUDY PROCEDURES AND ASSESSMENTS ....................................................22 
10.1. INFORMED CONSENT .............................................................................................22 
10.2. PARTICIPANT ID ASSIGNMENT............................................................................22 
10.3. STUDY TREATMENT COMPLIANCE ....................................................................23 
10.4. VISIT SCHEDULE AND EXAMS .............................................................................23 
10.5. STUDY EXIT ..............................................................................................................23 
11. 
EARLY TERMINATION AND PARTICIPANT DISCONTINUATION ...........23 

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12. 
STATISTICAL CONSIDERATIONS AND ANALYSIS ......................................25 
12.1. SAMPLE SIZE ............................................................................................................25 
12.2. RANDOMIZATION....................................................................................................25 
12.3. GENERAL CONSIDERATIONS ...............................................................................25 
12.4. MISSING DATA .........................................................................................................25 
12.5. STUDY OUTCOMES .................................................................................................25 
12.6. STATISTICAL HYPOTHESES ..................................................................................26 
12.7. STATISTICAL ANALYSES ......................................................................................26 
12.8. INTERIM ANALYSIS ................................................................................................27 
12.9. FINAL REPORT .........................................................................................................27 
13. 
ETHICAL AND REGULATORY CONSIDERATIONS ......................................27 
14. 
INVESTIGATOR RESPONSIBILITIES ................................................................28 
15. 
CONCOMITANT MEDICATIONS AND THERAPIES ......................................29 
15.1. PROHIBITED CONCOMITANT MEDICATIONS/PROCEDURES .......................29 
16. 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ................................30 
16.1. DEFINITION OF ADVERSE EVENTS (AE) ............................................................30 
16.2. DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) ........................................30 
16.3. CLASSIFICATION OF AN ADVERSE EVENT .......................................................30 
16.4. TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP
......................................................................................................................................32 
16.5. ADVERSE EVENT REPORTING..............................................................................33 
16.6. SERIOUS ADVERSE EVENT REPORTING ............................................................33 
16.7. REPORTING EVENTS TO PARTICIPANTS ...........................................................34 
16.8. REPORTING OF PREGNANCY ...............................................................................34 
17. 
COMPLIANCE WITH PROTOCOL......................................................................34 
18. 
PUBLICATION OF THE RESULTS AND PROTECTION OF COMMERCIAL 
SECRETS ...................................................................................................................35 
19. 
DATA COLLECTION AND REPORTING ...........................................................35 
20. 
APPENDIX A:   SCHEDULE OF VISITS AND EXAMS .....................................38 
21. 
PROTOCOL AMENDMENT HISTORY ...............................................................39 
22. 
APPENDIX B:  EXAMS AND PROCEDURES .....................................................40 
 

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23. 
REFERENCES ...........................................................................................................54 
 
 
 

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1. ABBREVIATION TABLE 
 
ADE 
Adverse drug effect 
AE 
Adverse event 
APEC 
Asociación para Evitar la Ceguera 
BID 
Twice a day 
 
 
CA 
California 
CDVA 
Corrected distance visual acuity 
CRF 
Case report form 
 
 
eCRF 
Electronic case report form 
EMEA 
European Medicines Evaluation Agency 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
EU 
European Union 
FDA 
Food and Drug Administration 
 
GABACls 
GABA-gated chloride channels 
GCP 
Good clinical practice 
GLP 
Good laboratory practice 
ICH 
International Conference on Harmonisation 
ID 
Identification 
IND 
Investigational New Drug 
IOP 
Intraocular pressure 
IPL 
Intense pulsed light 
IRB 
Institutional Review Board 
IUPAC 
International Union of Pure and Applied Chemistry 
LOCS 
Lens opacities classification system 
MedDRA 
Medical Dictionary for Regulatory Activities 
MD 
Doctor of medicine 
MGD 
Meibomian gland dysfunction 
NADA 
New Animal Drug Application 
NaFl 
Sodium fluorescein 
NC 
North Carolina 
NEI 
National Eye Institute 
NIBUT 
Non-invasive breakup time 
NOAEL 
No observed adverse effect level 
NOEL 
No observed effect level 
OD 
Doctor of optometry 
 
 
SAE 
Serious adverse event 
SPEED 
Standard Patient Evaluation of Eye Dryness questionnaire 
SUSAR 
Serious and unexpected suspected adverse reaction 

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TID 
Three times a day 
TP-03, 0.25% 
Lotilaner ophthalmic solution, 0.25% 
TRS 
Tarsus 
US 
United States 
VA 
Visual acuity 
VAS 
Visual analog scale 
WOCBP 
Women of childbearing potential 
 
2. INTRODUCTION AND RATIONALE 
2.1. MEIBOMIAN GLANDS 
Meibomian glands are sebaceous glands within the eyelids that secrete meibum, a compound 
primarily made of lipids that form the superficial layer of the tear film.  Meibum coats the 
aqueous layer and provides tear film stability and protection against microbial agents.1  In 
healthy individuals, there are approximately 25 to 40 glands in the upper eyelid and 
approximately 20 to 30 in the lower eyelid.2  Proper functioning of the glands serves many 
purposes including minimizing tear film evaporation, enhancing tear film stability, providing a 
smooth optical surface for the cornea, and sealing the opposing lid margins during sleep.3 
2.2. MEIBOMIAN GLAND DYSFUNCTION  
Meibomian gland dysfunction (MGD) is a common eyelid disorder4 that may well be the leading 
cause of dry eye disease throughout the world.5,6  Published literature cites a global incidence 
ranging widely from 3.5% to almost 70%.7  The incidence of MGD has been found to increase 
with age8–12 and is markedly higher in Asian populations.13–15  According to the International 
Workshop of Meibomian Gland Dysfunction, MGD is a chronic, diffuse abnormality of the 
meibomian glands, commonly characterized by terminal duct obstruction and/or 
qualitative/quantitative changes in the glandular secretion.  This may result in alteration of the 
tear film, symptoms of eye irritation, clinically apparent inflammation and ocular surface 
disease.16  Characteristic signs of MGD include the release of cloudy meibum or more viscous 
material on gland expression or an absence of expressible secretion.4  Meibomian gland 
dysfunction should be regarded as a progressive but treatable disease in which therapy may 
prevent irreversible changes.4 
Demodex mites have been implicated in several ocular surface diseases including dry eye 
syndrome17 associated with MGD.18–20  Luo and colleagues demonstrated that the Demodex-
positive rate in MGD patients is higher than that in the control group and that Demodex-positive 
patients experienced more severe meibomian gland loss.21  Other studies found that Demodex-
positive patients had more corneal and conjunctival pathologic features.22,23  In a retrospective 
review of clinical results, Gao et al24 identified MGD in addition to ocular demodicosis in seven 
of 11 subjects.  These subjects manifested abnormal lipid film with slow lipid film spread, 
intermittent trichiasis (n = 5) and subjective lash loss (n = 4) suggestive of damage to the 
meibomian glands and lash follicles.  The authors concluded that Demodex potentially causes 

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MGD, ocular surface inflammation and lash abnormalities.  A study by López-Ponce et al25 
found that the prevalence of infestation by D. folliculorum is high in patients with posterior 
blepharitis.  In addition, they found that parasite density was positively correlated with age and 
with the occurrence of collarettes on the eyelid border. 
Previous studies have found that Demodex mites can cause microstructural changes in 
meibomian glands, which can result in or aggravate MGD.26  A recent comparative study sought 
to understand the impact of Demodex infection on the lipid component of meibum in patients.27  
The authors found a significant increase in the levels of (O-acyl)-w-hydroxy fatty acids 
(OAHFAs) in the Demodex-positive group suggesting that OAHFAs may be associated with the 
progression of ocular Demodex infections.  The authors concluded that Demodex exert a 
significant effect on meibum composition in the human meibomian gland and proposed several 
possible mechanisms contributing to this change, all involving the movement of bacteria carried 
or secreted by Demodex mites. 
Other studies investigated the relationship between the area of meibomian gland loss and 
parameters of subjective symptoms and tear film.  Pult et al28 reported that meibomian gland loss 
was significantly correlated with lipid layer thickness, tear breakup time and subjective 
symptoms.  Ban et al29 reported that parameters of meibomian gland morphology such as the 
mean length of meibomian gland ducts and the percentage area of meibomian glands are 
significantly correlated with tear film parameters including tear breakup time and fluorescein 
staining.  These findings suggest that morphometric analysis using meibography may prove 
useful for assessing ocular surface conditions.    
Currently, there are no FDA-approved pharmaceutical treatments for MGD or Demodex 
blepharitis.  For MGD, the LipiFlow thermal pulsation system (Johnson & Johnson Vision), the 
iLux system (Tear Film Innovations) and the TearCare System (Sight Sciences) are the only 
devices to receive FDA clearance to date.  Other recommendations for the management and 
treatment of MGD include lid heating, massage, and lid hygiene; topical antibiotics and/or 
topical steroids; systemic anti-inflammatory antibiotics such as tetracycline; lubricants; 
meibomian gland probing; and meibomian gland expression.  For Demodex blepharitis, 
commercial products are prescribed without substantial evidence of effectiveness.30  In previous 
clinical trials, systemic ivermectin, metronidazole, their combination and topical tea tree oil have 
been used to treat blepharitis due to Demodex infestation with varying degrees of success.31–34  It 
should be noted, however, that terpinen-4-ol, a tea tree oil component, has been shown to be 
toxic to human meibomian gland epithelial cells in vitro, even at levels 10-fold to 100-fold lower 
than demodicidal concentrations.35  This study is being performed to compare two dosing 
regimens of a topical ophthalmic preparation of an established acaricide, TP-03, 0.25%, for the 
treatment of MGD in the presence of Demodex infestation. 

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3. TREATMENTS 
3.1. TP-03 AND VEHICLE 
Lotilaner is the investigational drug substance.  Lotilaner is an isoxazoline and inhibits the γ-
aminobutyric acid (GABA)-gated chloride channels (GABACls) of arthropods.  The GABA-
mediated chloride influx leads to hyperpolarization of the cellular membrane and generates an 
inhibitory postsynaptic potential, which decreases the probability of an action potential.36  
Ectoparasites exposed to isoxazolines will exhibit spastic paralysis leading to their starvation and 
death.  Isoxazolines as a chemical class have been shown to have no to very low affinity to the 
human GABA receptor and the GABA pathway is not activated in humans.   
Vehicle of TP-03 
 
The vehicle of TP-03 will be used to maintain masking of the BID dosing.  Specifically, the 
concentrations of the excipients match TP-03, lotilaner ophthalmic solution, 0.25%.   
 

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7. Treatment of blepharitis within 14 days of Day 1 (e.g., topical tea tree oil or hypochlorous 
acid) or unwilling to forego the use of these treatments for the duration of the study 
8. The use of lid hygiene products such as lid scrubs, warm compresses or lid massage within 
7 days of Day 1 or unwilling to forego the use of these treatments for the duration of the 
study 
 
 
10. Have used artificial eyelashes, eyelash extensions or had other cosmetic eyelash or eyelid 
procedures (e.g., eyeliner tattooing, eyelash tinting, eyelash curling perm, etc.) within 7 days 
of Day 1 or be unwilling to forego their use during the study  
11. Contact lens wear within 7 days of Day 1 or unwilling to forego contact lens wear for the 
duration of the study  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Both preparations should be stored at ambient room temperature, 20° to 25° C (68° to 77° F) per 
USP.  Excursions between 15° and 30° C (59° and 86° F) that are experienced in pharmacies, 
hospitals, ophthalmic practices, warehouses, and during shipping are allowed.  There are no light 
requirements, but extreme humidity conditions should be avoided.   
Participants will be instructed to store the study drug at room temperature in a climate-controlled 
environment avoiding extreme heat or cold and extreme humidity conditions.  In addition, 
participants will be advised that the study drug should not be kept at temperatures higher than 
40° C (or 104° F) for longer than 24 hours. 
10. STUDY PROCEDURES AND ASSESSMENTS 
10.1. 
INFORMED CONSENT 
Prior to performing any study-specific procedures, potential study participants will be provided 
with an IRB-approved informed consent form and be given a chance to review and ask questions 
before written informed consent is obtained.   
The potential study participant will be asked to sign and date the informed consent form.  The 
individual explaining the consent will also sign and date the consent form as required.  The 
original will be retained with the potential study participant’s medical records and a copy will be 
provided to the potential study participant. 
10.1.1. RECONSENTING  
Prior to performing any study-specific procedures specific to Day 115, potential study 
participants who exited the study per protocol version 3.0 and participants who have not exited 
the study will be provided with an IRB-approved informed consent form and given a chance to 
review and ask questions before written informed consent is obtained.     
The potential study participant or enrolled study participant will be asked to sign and date the 
informed consent form.  The individual explaining the consent will also sign and date the consent 
form as required.  The original will be retained with the study participant’s medical records and a 
copy will be provided to the study participant.  
10.2. 
PARTICIPANT ID ASSIGNMENT    
While undergoing screening, potential study participants who sign an informed consent form will 
be identified by their initials and unique subject ID.  For the initials, a dash (-) will be used in 
place of the middle initial for potential participants who have no middle name.  The unique 
subject ID will consist of the site number followed by a hyphen and then the screening number.  
For each site, the screening number is a 4-digit number assigned in sequential order beginning 
with 0101.   
If a potential study participant has provided written informed consent and met all eligibility 
criteria, the participant will be considered enrolled in the study.  Once the participant has been 
enrolled, the site will supervise the administration of the first dose of the study medication. 
Potential participants who have provided written informed consent but fail to meet eligibility 
criteria and are screened again on a different day will be assigned a new unique subject ID that is 

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Possible reasons for study discontinuation include the following: 
• Lack of efficacy: the participant does not feel that the study drug has adequately relieved 
his/her symptoms 
• AEs necessitating discontinuation from the study 
• The participant is lost to follow-up 
• Participant decision unrelated to lack of efficacy or AEs 
• Reasons relating to COVID-19 
• Investigator decision (specify) 
• Other reason (specify) 
If a participant chooses to discontinue his/her participation or is discontinued, the Exit Form will 
be completed regardless of other information available.  Should a participant experience any 
difficulties requiring review between planned visits, or in case of early exit between planned 
visits, the Unscheduled Visit Form will be completed.  Reason(s) for such a visit will be recorded 
on the CRF.  Discontinued participants will not be replaced.  Participants to be discontinued for 
AE(s) will be followed until the event is resolved, if possible, or considered medically stable by 
the investigator. 
The data to be collected at the time of study treatment discontinuation may include the 
following: 
• An AE assessment and performance of safety assessments including visual acuity and slit 
lamp biomicroscopy 
• Any follow-up evaluations required per investigator determination 
Temporary discontinuation of the study treatment could include the onset of such conditions as 
allergic conjunctivitis or signs or symptoms of eyelid allergy (e.g., injection, swelling, itching, 
etc.).  Per investigator discretion, the study treatment could be discontinued until such a time that 
the adverse event has shown sufficient improvement such that the study treatment could be re-
started.  Re-challenging with the study treatment could help to determine if the adverse event is 
related to the study drug.  It should be noted that discontinuation from use of the study treatment 
does not mean discontinuation from the study, and remaining study procedures should be 
completed as indicated by the study protocol.  
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site will attempt to contact the participant and reschedule the missed visit as soon as 
possible, counseling the participant on the importance of continuing the administration of the 
study drop and of maintaining the assigned visit schedule.  In addition, the site should 
ascertain if the participant wishes to and/or should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, three telephone calls and, if 
necessary, a certified letter to the participant’s last known mailing address or local equivalent 
methods).  These contact attempts should be documented in the participant’s medical record 
or study file.  

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• Purpose of the study including the potential duration of participation by the participant and a 
description of the procedures 
• Possible side effects, risks or discomforts of the investigational drug 
• Reasonably expected benefits 
• The existence of alternative therapy options and/or alternatives to participating in the study 
• Confidentiality of records and possible inspection of records 
• Costs, compensation and treatment for injury 
• Person to contact regarding participant’s rights 
• Person to contact for questions on research or research-associated injury 
• Participation is voluntary 
• The right to discontinue participation in the study at any time without disadvantage to the 
participant 
• Participant will be informed of new information learned during the study, which may affect 
the participant’s decision to continue participation in the study 
The investigator or qualified/delegated staff will obtain written informed consent from each 
participant prior to the initiation of any study-related activities.  The potential study participant 
or the participant’s legally authorized representative will be allowed sufficient time to thoroughly 
read (or have read and explained to them) the informed consent form.  The investigator or 
qualified/delegated staff will answer any questions that the potential study participant or their 
representative might have.  If the potential study participant agrees to participate in the study, all 
required parties should sign and date the informed consent form.  The original signed informed 
consent form will be retained by the site and a copy will be given to the potential study 
participant for their records.  The obtaining of informed consent and the date of that informed 
consent should be noted in the participant’s medical notes.  It should also be noted that informed 
consent was obtained prior to any study-related activities being conducted. 
14. INVESTIGATOR RESPONSIBILITIES 

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• Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures.  Moderate events may cause some interference with functioning. 
• Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment.  Severe events are usually potentially life-threatening or 
incapacitating.   
 
Of note, the term “severe” does not necessarily equate to “serious.”  Severity is a measurement 
of intensity.  Thus, a severe reaction is not necessarily an SAE.  For example, a headache may be 
severe in intensity but would not be serious unless it met one or more of the criteria for a serious 
adverse event. 
16.3.2. RELATIONSHIP TO STUDY TREATMENT 
All AEs must have their relationship to study treatment assessed by the clinician who examines 
and evaluates the participant based on temporal relationship and his/her clinical judgment.  The 
degree of certainty about causality will be graded using the categories below.  In a clinical trial, 
the study product must always be suspect.  
 
• Definitely Related – Evidence indicates a reasonable temporal sequence of the event with 
the study drug administration exists or that the association of the event with study drug 
administration is unknown and the event is not reasonably supported by other conditions 
such that: 
o There is a clinically plausible time sequence between onset of the AE and study treatment 
administration, and/or 
o There is a biologically plausible mechanism for study treatment causing or contributing 
to the AE, and 
o The AE cannot be reasonably attributed to concurrent/underlying illness, other drugs or 
procedures. 
• Potentially Related – Evidence indicates a possible relationship to the study drug such that: 
o The event occurs within a reasonable period of time relative to the treatment that makes a 
causal relationship possible, but plausible explanations may also be provided by other 
causes such as other drugs, products, chemicals, underlying disease, environment, etc. 
o The event is possibly related to the study treatment. 
• Not Related – Evidence indicates no plausible direct relationship to the study drug such that: 
o A clinically plausible temporal sequence is inconsistent with the onset of the AE and drug 
administration, and/or 
o A causal relationship is considered biologically implausible 
o The AE can be attributed to concurrent/underlying illness, other drugs or procedures. 
16.3.3. EXPECTEDNESS 
The investigator will determine whether an AE is expected or unexpected.  An AE will be 
considered unexpected if the nature, severity, or frequency of the event is not consistent with the 
risk information previously described for the study treatment.  Expectedness should be 
determined if the AE is characterized as related to treatment and is serious (met one or more of 
the criteria for an SAE). 

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16.3.4. OUTCOME 
The clinical outcome of an AE will be characterized as follows: 
• Resolved without sequelae 
• Resolved with sequelae (specify) 
• Death 
• Ongoing (i.e., continuing at the time of study discontinuation) 
• Unknown 
16.3.5. TREATMENT OR ACTION TAKEN 
 
The clinical treatment or action taken from an AE will be characterized as follows: 
• None 
• Medical intervention 
• Surgical intervention 
• Unknown 
• Other (specify) 
16.3.6. ACTION TAKEN WITH INVESTIGATIONAL PRODUCT 
The action taken with the IP will be characterized as follows: 
• None 
• Drug temporarily withdrawn 
• Drug discontinued 
• 
Unknown 
16.4. 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND 
FOLLOW-UP 
The occurrence of an AE or SAE may come to the attention of study personnel during study 
visits and interviews of a study participant presenting for medical care or upon review by a study 
monitor.  At study visits, study personnel should pose general questions to the participant to 
ascertain if the participant experienced any issues prior to the visit.  
 
All AEs, including local and systemic reactions not meeting the criteria for SAEs, will be 
captured on the appropriate CRF/eCRF.  Information to be collected includes event description, 
date of onset, clinician’s assessment of severity, relationship to study product (assessed only by 
those with the training and authority to make a diagnosis), and date of resolution/stabilization of 
the event.  All AEs occurring while in the study must be documented appropriately regardless of 
relationship to the study product.   
 
Any medical condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE.  However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE.  
 

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Changes in the severity of an AE will be documented to allow an assessment of the duration of 
the event at each level of severity to be performed.   
 
The investigator or designee will record all reportable events with start dates occurring any time 
after the study drug is first administered until 7 (for non-serious AEs) or 30 days (for SAEs) after 
the last day of study participation.  At each study visit, the investigator will inquire about the 
occurrence of AE/SAEs since the last visit.  Events will be followed for outcome information 
until resolution or stabilization. 
 
Whenever possible, recognized medical terms should be used when recording AEs.  
Colloquialisms and/or abbreviations should not be used.  Only one medical concept, preferably a 
diagnosis instead of individual symptoms, should be recorded as the event (e.g., record 
congestive heart failure rather than dyspnea, rales and cyanosis).  However, if a constellation of 
signs and/or symptoms cannot be medically characterized as a single diagnosis or syndrome at 
the time of reporting, each individual sign or symptom should be recorded as a separate AE.  A 
diagnosis that is subsequently established should be reported as follow-up information.   
 
Adverse events occurring secondary to other events (e.g., sequelae) should be identified by the 
primary cause.  A “primary” event, if clearly identifiable, should represent the most accurate 
clinical term to record as the AE event term.  For example: Orthostatic hypotension ⇒ fainting 
and fall to floor ⇒ head trauma and neck pain.  The primary event is orthostatic hypotension and 
the sequelae are head trauma and neck pain. 
16.5. 
ADVERSE EVENT REPORTING 
The investigator must record nonserious adverse events and submit on the CRF/eCRF in a timely 
manner.  
16.6. 
SERIOUS ADVERSE EVENT REPORTING 
The study clinician will immediately report to the sponsor and Medical Monitor any SAE, 
whether or not considered study treatment-related, including those listed in the protocol or 
Investigator’s Brochure and must include an assessment of whether there is a reasonable 
possibility that the study treatment caused the event [21 CFR 312.64(b)].  Serious adverse events 
must be reported immediately to the below-listed individuals using the Serious Adverse Event 
Report (SAER) form.  Sites will also be instructed to document the event in the Serious Adverse 
Event eCRF. 

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All SAEs will be followed until satisfactory resolution or until the site investigator deems the 
event to be chronic or the participant is stable.  Other supporting documentation of the event may 
be requested by the study sponsor and should be provided as soon as possible. 
 
The study sponsor or designee will be responsible for notifying the Food and Drug 
Administration (FDA) of any unexpected fatal or life-threatening suspected adverse reaction as 
soon as possible, but in no case later than 7 calendar days after the sponsor’s initial receipt of the 
information [21 CFR 312.32I(2)].  In addition, the sponsor must notify the FDA and all 
participating investigators in an Investigational New Drug (IND) safety report of potentially 
serious risks from clinical trials or any other source as soon as possible, but in no case later than 
15 calendar days after the sponsor determines that the information qualifies for reporting [21 
CFR 312.32I(1)].  In each IND safety report, the sponsor must identify all IND safety reports 
previously submitted to the FDA concerning a similar suspected adverse reaction and must 
analyze the significance of the suspected adverse reaction in light of previous, similar reports or 
any other relevant information.  The sponsor must report any suspected adverse reaction that is 
both serious and unexpected.  The sponsor must report an AE as a suspected adverse reaction 
only if there is evidence to suggest a causal relationship between the drug and the AE. 
16.7. 
REPORTING EVENTS TO PARTICIPANTS 
It will be the responsibility of the principal investigator to inform participants of any AEs or 
SAEs deemed related to the study drug and of any study-related results. 
16.8. 
REPORTING OF PREGNANCY 
Women of Childbearing Potential (WOCBP) includes any females who have experienced 
menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral 
tubal ligation or bilateral oophorectomy) or are not postmenopausal at least 12 months since last 
menses.  WOCBP will be required to use designated methods of birth control during the course 
of the study.  All women who are pregnant, nursing an infant or planning a pregnancy during the 
duration of this study will be excluded from participation.  
If a participant or investigator suspects that the participant may be pregnant prior to study drug 
administration, the study drug should be withheld until the results of pregnancy testing are 
available.  If pregnancy is confirmed, the participant should not administer the study drug and 
should not be enrolled in the study. 
If a female participant becomes pregnant during the study, use of the study drug should be 
discontinued immediately.  The investigator will notify the sponsor (or designee) immediately 
after the pregnancy is confirmed.  The investigator will (1) obtain a consent from the female 
participant for pregnancy follow-up and (2) follow the progress of the pregnancy to term.  The 
investigator should document the outcome of the pregnancy and provide a copy of the 
documentation to the sponsor or designee.  The sponsor or sponsor’s designee will be 
responsible for reporting to the IRB and regulatory agencies as appropriate. 
17. COMPLIANCE WITH PROTOCOL 

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The CRFs/eCRFs will be monitored and corrected on-site and, if necessary, clarified on an 
ongoing basis.  The site will be queried if any data, signatures or forms are missing or incorrect.  
Case report forms can be used as source documents where appropriate.   
Monitoring and Inspection of Records:  The investigator must allow regular inspections of all 
study records including CRFs/eCRFs, source documents and regulatory documents by the study 
monitor.  This measure is to ensure that the study is carried out and documented in accordance 
with all regulatory requirements and the terms of this protocol. 
In cooperation with the on-site staff, a designated study monitor(s) will: 
• Review all study documents to ensure compliance with the protocol 
• Review data recordings for each visit to verify the accuracy and completeness of the 
information on the CRFs/eCRFs against appropriate source documents 
• Review drug disposition and accountability records 
• Review adequacy of enrollment rate 
• Review required regulatory documentation 
Record Retention: The investigator is responsible for maintaining adequate records to enable the 
conduct of the study to be fully documented.  This includes: 
• The Investigator’s Brochure, signed protocol and amendments 
• Signed and dated informed consents per institutional policy 
• Signed, dated, and completed CRFs/eCRFs and documentation of CRF corrections 
• Notification of SAEs and related reports 
• All study drug dispensing and accountability logs 
• Shipping records of investigational drug and trial-related materials 
• Dated and documented IRB protocol approvals and all correspondence between the 
investigator and IRB 
• Curriculum vitae and current medical licenses for principal investigator and all sub-
investigators 
Source documents:  The investigator is responsible for maintaining adequate case histories in the 
source documents of each participant.  The following data will be noted by the investigator in the 
source medical records of each participant enrolled in the study:   
• The participant is participating in this clinical trial  
• The date the informed consent form was signed  
• Kit numbers  
• Date of study completion or withdrawal   
The investigator must maintain a copy of all study documents for the period of time that is 
required by the regulatory authorities.  No documents will be destroyed without prior written 
permission from Tarsus Pharmaceuticals. 

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Data Management: The data will be entered into a secure study database.  The database will be 
electronically stored and a copy placed in backup on a regular basis.  Case report forms will be 
stored for reference.  Any data inconsistencies will be resolved by a data clarification request and 
final resolution verified during site monitoring and study closure.  Study documents should be 
retained for a minimum 
 after the last approval of a marketing application and until 
there are no pending or contemplated marketing applications or until at 
 have 
elapsed since the formal discontinuation of clinical development of the study treatment.  These 
documents should be retained for a longer period, however, if required by local regulations.  No 
records will be destroyed without the written consent of the sponsor.  It is the responsibility of 
the sponsor to inform the investigator when these documents no longer need to be retained.   
Protocol Amendments: Any amendments to the protocol must be approved by the IRB in 
advance of implementation. 
Deviations from Clinical Investigation Plan: All deviations from the protocol should be clearly 
documented.  Deviations conducted to protect a participant from possible hazards should be 
reported to the IRB as soon as possible. 
 

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21. PROTOCOL AMENDMENT HISTORY 
 

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