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Cohort of transgender people (man to woman and woman to man)

Jade GHOSN, MD PhD

The goal of this observational study is to estimate the prevalence of HPV infections anal and ENT level and according to HIV status in transgender (TG) population. The main question it aims to answer is:

* What is the prevalence of HPV lesions in transgender population (TG);
* What kind of high risk HPV (hrHPV) and low risk HPV (lrHPV) are detected at the genital, anal and ENT level

Context:

The few publications with an individualized transgender (TG) population have been conducted in South America (Peru, Argentina) showing very high anal or ano-genital hrHPV prevalences of around 97% (dos Ramos Farias et al., 2011; Brown et al., 2016). Recently a study conducted in 22 TGs showed a high prevalence of anal dysplastic lesions with low grade lesions detected in 8 individuals and high grade in 3 individuals (Kobayashi et al., 2017). Thus, in the face of this high prevalence of 50% anal dysplasia, the TG population therefore appears to be at risk for developing anal dysplastic lesions and this needs to be explored in another TG population. Furthermore, to our knowledge, no study has evaluated the concomitant prevalence of hrHPV infection at the anogenital and ENT levels in the transgender population. The Infectious and Tropical Diseases Department of Bichat-Claude Bernard Hospital is particularly involved in the follow-up of transgender individuals with a large active file that participates in clinical research projects (Pommier et al., 2019; Bertin et al., 2019; Phung et al., 2018).

Objectives:

Principal objective The primary objective of this study is to determine the prevalence of HPV lesions in transgender population (TG).

Secondary objectives

Secondary objectives include:

1. Estimate the prevalence of HPV infections at the genital, anal and ENT level and according to HIV status;
2. To estimate the prevalence of hrHPV infections at the genital, anal and ENT levels, globally and according to HIV status;
3. To estimate the prevalence of lrHPV infections at the genital, anal and ENT level globally and by HIV status;
4. Describe the types of hrHPV and lrHPV detected at the genital, anal and ENT level;
5. To estimate the prevalence of dysplastic lesions (low grade and high grade) by HIV status;
6. To estimate the prevalence of bacterial Sexually Transmitted Infections (STIs): Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally and by anatomical site and HIV status.

Methodology This is a national, non-interventional, cross-sectional, monocentric study among TG people (man to woman, and woman to man)

Estimated enrolment 200 participants

Outcomes Primary outcome:

The prevalence of HPV infections among TG people. Prevalence is defined as the percentage of subjects with HPV infection among TG people included, regardless the site where infection was detected.

Secondary outcomes:

1. The prevalence of HPV infections in each anatomical site (genital, anal and ENT) and by HIV status.
2. The prevalence of hrHPV infections in each anatomical site (genital, anal and ENT), globally and according to HIV status.
3. The prevalence of lrHPV infections in each anatomical site (genital, anal and ENT), globally and by HIV status.
4. The types of hrHPV and lrHPV in each anatomical site (genital, anal).
5. The prevalence of dysplastic lesions (low grade and high grade) by HIV status.
6. The prevalence of bacterial STIs: Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally, by anatomical site and HIV status.

Eligibility Inclusion criteria

* Age ≥ 18 years
* To belong to transgender population : i.e. people who doesn't identify to the gender assigned at birth
* To be affiliated to a social security system or be beneficiary of the Aide Médicale d'Etat (AME)

Non-inclusion criteria

* To have ever been vaccinated against HPV
* Research participation refusal
* People under guardianship or curatorship, or deprived of liberty by administrative or judiciary measure

Statistical methods Individuals' characteristics will be described for all included subjects. Continuous variables will be described using mean, standard deviation, median, interquartiles values, minimal and maximal values. Qualitative variables will be described using numbers and percentages by modality. Prevalences will be described by proportion and their confidence interval will be calculated under binomial law. All statistical tests will be performed using 5% as significance level. Prevalence of high risk HPV infection in each anatomical site and the concordance of HPV types by anatomical site will be determined using Fleiss Kappa test.

HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population

Prevalence of Genital, Anal and Oral HPV Infection and Sexually Transmitted Infections, and of Anal Dysplasia in the Transgender Population (PrevHPV-TG)

The prevalence of HPV infections is defined as the percentage of subjects with HPV infection among transgender people included, regardless the site of infection.

We will estimate the prevalence of HPV infections in each anatomical site (genital, anal and ENT) and according to HIV status.

We will estimate the prevalence of hrHPV infections in each anatomical site (genital, anal and ENT), globally and according to HIV status.

We will estimate the prevalence of lrHPV infections in each anatomical site (genital, anal and ENT), globally and by HIV status.

We will describe the types of hrHPV and lrHPV detected at the genital, anal and ENT level

We will estimate the prevalence of dysplastic lesions (low grade and high grade) by HIV status.

We will estimate the prevalence of bacterial sexually transmitted infections: Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally, by anatomical site and HIV status.

ANRS, Emerging Infectious Diseases

Skin and Connective Tissue Diseases

Neoplasms

Skin Diseases

Condylomata Acuminata

Papilloma

Warts

Skin Diseases, Infectious

Skin Diseases, Viral

Pharmaceutical Solutions

All Drugs and Chemicals

Cantharidin

Enzyme Inhibitors

For part A, VP-102 will be applied for 2 hours and removed. If selected as a dose regimen for Part B VP-102 will be applied for 2 hours and removed.In both parts, VP-102 is applied every 21 days for 4 treatments.

For part A, VP-102 will be applied for 6 hours and removed. If selected as a dose regimen for Part B VP-102 will be applied for 6 hours and removed. In both parts, VP-102 is applied every 21 days for 4 treatments.

For part A, VP-102 will be applied for 24 hours and removed. If selected as a dose regimen for Part B, VP-102 will be applied for 24 hours and removed. In both parts, VP-102 is applied every 21 days for 4 treatments.

For part A, VP-102 will be applied for 2-,6- or 24- hours and removed. Placebo is applied every 21 days for 4 treatments.

Part B, VP-102 will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part B, Placebo will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.

For part A, VP-102 will be applied for 24 hours and removed. If 24 hours is selected as a dose regimen for Part B, VP-102 will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part B, VP-Placebo will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments.

In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.

VP-102 and applicator

The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin

Placebo

Scott Guenthner, MD

This is a Phase 2, double-blind, placebo-controlled study to determine the dose regimen, safety, tolerability, and efficacy of VP-102 in subjects with External Genital Warts (EGW). This study is divided into two parts (Part A and Part B). Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups prior to progressing to enrollment in Part B. Part A \& B will enroll a approximately 108 subjects completing 4 treatment applications every 21 days and continuing with follow-up assessments at Day 84, 112 and 147.

This study is to determine the Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects with External Genital Warts. It is divided into two parts (Part A and Part B). The aim of Part A is to determine the two best treatment regimens for evaluation of safety and efficacy in Part B.In Part A, Study drug (VP-102 or placebo) will be administered once every 21 days for up to four applications. Enrollment will begin in Group 1, then proceed into Group 2, and lastly into Group 3. A safety review will be conducted to determine whether enrollment can be initiated into the next Group. An additional blinded safety review will be performed after all six subjects in Group 3 have completed the 48-hour Visit, in order to support dose selection for Part B (Safety and Efficacy). Part B of the study will begin enrollment only after the Sponsor has selected the two dose regimens from Part A. The study will remain blinded until completion of both parts of the study.

In Part A, up to 18 subjects will be randomized to VP-102 or placebo treatment with three different regimens. When Part B is open an additional \~90 subjects will be enrolled and randomized to VP-102 or placebo with two treatment regimens. Two of the treatment arms will be VP-102 Regimen 1 and VP-102 Regimen 2. The other two treatment arms will be placebo (Placebo Regimen 1 and Placebo Regimen 2), with corresponding durations of skin exposure matching those selected for VP-102 Regimen 1 and Regimen 2. As an example, if the regimens selected from Part A are the 2-hour and 6-hour applications of VP-102, then VP-102 Regimen 1 would be VP-102 treatment for 2-hours and VP-102 Regimen 2 would be VP-102 treatment for 6-hours. Likewise, Placebo Regimen 1 would be placebo treatment for 2 hours and Placebo Regimen 2 would be placebo treatment for 6-hours. Randomization of the four treatment arms (VP-102 Regimen 1:VP-102 Regimen 2:Placebo Regimen 1:Placebo Regimen 2) will be 3:3:2:2. In both Regimen 1 and Regimen 2, study drug will be administered to EGW once every 21 days for up to four applications. Subjects will be asked to remove the study drug at the designated time selected from the dose regimen findings in Part A of the study. Treatment will continue with a minimum of every 21 days, until complete clearance or a maximum of four treatment sessions. Safety assessments including recording of local skin reactions are conducted at each treatment visit and at follow up visits Day 84, 112, and 147.

The aim of Part A is to determine the two best treatment regimens for evaluation of safety and efficacy in Part B. Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups (n=6/group) that will enroll progressively.

Part B of the study will begin enrollment only after the Sponsor has selected the two dose regimens in Part A, which will be called VP-102 Regimen 1 and Regimen 2.Approximately 90 subjects will be enrolled and randomized to one of four treatment arms (two treatment regimens, each with VP-102 and Placebo). Randomization will be stratified by sex so that neither gender exceeds \~60% of any treatment arm. Two of the treatment arms will be VP-102 Regimen 1 and VP-102 Regimen 2. The other two treatment arms will be placebo (Placebo Regimen 1 and Placebo Regimen 2), with corresponding durations of skin exposure matching those selected for VP-102 Regimen 1 and Regimen 2.

A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts

A Phase 2, Double-Blind, Placebo-Controlled Study to Determine the Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects With External Genital Warts

Proportion of subjects exhibiting reduction of ≥ 1 treatable wart from baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Proportion of subjects who are clear at all three study visits, Study Day 84 (End of Treatment) Visit and remain clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study).

Change from baseline in total wart area (sum of individual warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Percent Change from baseline in the total wart area (sum of individual warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.

Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Proportion of subjects exhibiting 90% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Proportion of subjects exhibiting 75% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Number of warts present were recorded at each treatment visit as well as follow-up visits. For each post baseline treatment visit, the change in number of warts from baseline was calculated.

Percent Change from Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Instat Consulting, Inc.

Paidion Research, Inc.

BioClinica, Inc.

Verrica Pharmaceuticals Inc.

TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.

Data will be summarized for both Part B pooled with Part A for the applicable treatments.

Part B Pooled With Part A: VP-102 6-hour

Part B Pooled With Part A: Placebo 6-hour

Part B Pooled With Part A VP-102 24-hour

Part B Pooled With Part A: Placebo 24-hour

Part A: VP-102 2-hour

Data summarized for VP-102 2-hour group..

Part A: Placebo 2-hour

VP-102 will be applied for 2-hours and removed. VP-102 is applied every 21 days for 4 treatments.

VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part A: VP-102 6-hour

VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part A: VP-102 24-hour

Placebo will be applied for 2-,6- or 12-hours and removed. Placebo is applied every 21 days for 4 treatments.

Part A: Placebo

Part B: VP-102 6-hour

Placebo will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part B: 6-hour-Placebo

Part B: VP-102 24-hour

Placebo will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part B: 24-hour-Placebo

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Baseline number of treatable external genital warts

Due to logistical and/or scheduling difficulties related to the SARS-CoV-2 (coronavirus-19; COVID-19) pandemic during the course of the study, six subjects discontinued due to COVID-19 related reasons.

Susan Cutler, VP, Medical Affairs

Part B summary is pooled with its respective treatments from Part A.

Part B and A: Intent-to-Treat Population. Part B summary is pooled with its respective treatments from Part A.

Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.

Treatment Visit 2 - Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.

Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2: Yes, Complete Clearance

Treatment Visit 3: Yes, Complete Clearance

Treatment Visit 4: Yes, Complete Clearance

Study Day 84 EOT: Yes, Complete Clearance

F/U Visit Day 112: Yes, Complete Clearance

F/U Visit Day 147: Yes, Complete Clearance

Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.

Study Day84 EOT Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.

Study Day 84 EOT Visit Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2: Incidence of >=90% Clearance: YES

Treatment Visit 3: Incidence of >=90% Clearance: YES

Treatment Visit 4: Incidence of >=90% Clearance: YES

Study Day 84 EOT: Incidence of >=90% Clearance: YES

F/U Visit Day 112: Incidence of >=90% Clearance: YES

F/U Visit Day 147: Incidence of >=90% Clearance: YES

Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.

Study Day 84 (EOT) visit: Part B summary is pooled with its respective treatments from Part A.

Study Day 84 (EOT) Visit: Part B summary is pooled with its respective treatments from Part A.

Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.

Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2: Incidence of >=75% Clearance: YES

Treatment Visit 3: Incidence of >=75% Clearance: YES

Treatment Visit 4: Incidence of >=75% Clearance: YES

Study Day 84 EOT: Incidence of >=75% Clearance: YES

F/U Visit Day 112: Incidence of >=75% Clearance: YES

F/U Visit Day 147: Incidence of >=75% Clearance: YES

Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.

Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.

Treatment visit 2: Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 3: Degrees of freedom associated with the error term were computed using Kenward-Rogers method.

Treatment visit 4: Part B summary is pooled with its respective treatments from Part A.

Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.

Follow up day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2

Treatment Visit 3

Treatment Visit 4

Study Day 84 EOT Visit

Follow up Day 112

Follow-up Visit Day 147 EOS

Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.

Follow up Day 112: Part B summary is pooled with its respective treatments from Part A.

Follow up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.

Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.

Study Day 84 End of Treatment Visit

Follow up Visit Day 147 End of Study

Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Study Day 84 EOT: Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.

F/U Visit Day 112

F/U Visit Day 147 EOS

Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study)

Study Day 84 (EOT: Part B summary is pooled with its respective treatments from Part A.

Study Day 112 (EOT: Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.

Study Day 84 (EOT)

Follow-up Day 112

Follow-up Visit Day 147 (EOS)

Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Follow-up Day 147 (EOS)

Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.

Part A: VP-102 6-hour Group

Part A: VP-102 24-hour Group

This includes 3 subjects that received placebo (1 each for the 2-hour; 6-hour and 24-hour)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population	NCT05981807	Human Papilloma... Human Immunodef... Sexually Transm...		18 Years -	ANRS, Emerging Infectious Diseases
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts	NCT03981822	Condylomata Acu... Papillomavirus ... Skin Diseases, ... Skin Diseases, ... Skin Diseases Sexually Transm... Sexually Transm... Warts	VP-102 and appl... Placebo	18 Years -	Verrica Pharmaceuticals Inc.
Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)	NCT02535104	Condylomata Acu... Papillomavirus ... Sexually Transm...	Ranpirnase Vehicle	18 Years - 60 Years	Tamir Biotechnology, Inc.
Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population	NCT01598779	Condylomata Acu...		15 Years - 45 Years	University of Buenos Aires
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts	NCT03981822	Condylomata Acu... Papillomavirus ... Skin Diseases, ... Skin Diseases, ... Skin Diseases Sexually Transm... Sexually Transm... Warts	VP-102 and appl... Placebo	18 Years -	Verrica Pharmaceuticals Inc.
Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population	NCT01598779	Condylomata Acu...		15 Years - 45 Years	University of Buenos Aires
Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients	NCT02401867	Uterine Cervica... Sexually Transm...		21 Years - 64 Years	Fenway Community Health
Trial of Male Circumcision: HIV, Sexually Transmitted Disease (STD) and Behavioral Effects in Men, Women and the Community	NCT00124878	HIV Infections Sexually Transm... Papillomavirus ... Genital Herpes Gonorrhea Chlamydia Infec... Syphilis Bacterial Vagin...	Male circumcisi...	15 Years - 49 Years	Wawer, Maria J., M.D.
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts	NCT03981822	Condylomata Acu... Papillomavirus ... Skin Diseases, ... Skin Diseases, ... Skin Diseases Sexually Transm... Sexually Transm... Warts	VP-102 and appl... Placebo	18 Years -	Verrica Pharmaceuticals Inc.
Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)	NCT02535104	Condylomata Acu... Papillomavirus ... Sexually Transm...	Ranpirnase Vehicle	18 Years - 60 Years	Tamir Biotechnology, Inc.

Spots Global Cancer Trial Database for sexually transmitted diseases