Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03981822
Study type Interventional
Source Verrica Pharmaceuticals Inc.
Contact
Status Completed
Phase Phase 2
Start date June 25, 2019
Completion date July 8, 2020

See also
  Status Clinical Trial Phase
Completed NCT02579135 - Reducing HIV Risk Among Adolescents: Evaluating Project HEART N/A
Completed NCT04121962 - A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence) N/A
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Recruiting NCT05889689 - Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters N/A
Completed NCT02516930 - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China N/A
Completed NCT03063385 - Puerto Rico Cuidalos Parent-adolescent Program N/A
Completed NCT01411878 - Louisville Teen Pregnancy Prevention Project N/A
Completed NCT02009046 - Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students N/A
Completed NCT01303575 - Internet-Based Sexual Health Education for Middle School Native American Youth N/A
Completed NCT00167505 - All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students N/A
Completed NCT00183456 - A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs Phase 2
Completed NCT00336180 - Adolescent Drug and HIV Prevention in South Africa Phase 2/Phase 3
Completed NCT00710060 - Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations Phase 3
Completed NCT01084395 - Reducing HIV Risk Among Mexican Youth N/A
Completed NCT00161382 - Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students N/A
Completed NCT00640653 - Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents N/A
Completed NCT00289939 - Reducing HIV & Domestic Violence Risk in Women Offenders Phase 3
Completed NCT00137943 - Parents Matter!: Interventions to Promote Effective Parent-Child Communication Phase 1
Completed NCT03408743 - Engineering an Online STI Prevention Program: CSE2 N/A
Completed NCT06104813 - Evaluation of Deaf Men's Knowledge About Sexual Health