Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03981822
Recruitment Status : Not yet recruiting
First Posted : June 11, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
Instat Consulting, Inc.
Paidion Research, Inc.
BioClinica, Inc.
Information provided by (Responsible Party):
Verrica Pharmaceuticals Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Condylomata Acuminata Papillomavirus Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Warts Combination Product: VP-102 and applicator Phase 2

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 10, 2019
Estimated Primary Completion Date : August 12, 2020
Estimated Study Completion Date : October 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Active Comparator: Part A & B 2 hour-Active
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.
Combination Product: 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.

Placebo Comparator: Part A & B 2 hour-Placebo
For part A. Placebo will be applied for 2 hours and removed. If 2 hour is selected as a dose regimen for Part B, Placebo will be applied for 2 hours and removed.VP-102 is applied every 21 days for 4 treatments.
Combination Product: 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.

Active Comparator: Part A & B 6 hour-Active
For part A, VP-102 will be applied for 6 hours and removed. If 6 hours is selected as a dose regimen for Part B, VP-102 will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.
Combination Product: 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.

Placebo Comparator: Part A & B 6-hour-Placebo
For part A, Placebo will be applied for 6 hours and removed. If 6 hours is selected as a dose regimen for Part B, Placebo will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.
Combination Product: 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.

Active Comparator: Part A & B 24-hour Active
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.
Combination Product: 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.

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




Primary Outcome Measures :
  1. Proportion of subjects exhibiting complete clearance of all treatable warts at the Study Day 84 (End of Treatment) Visit. [ Time Frame: Compares baseline wart count to Day 84, end of treatment. ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: Clearance compared from baseline to each study visit, treatment 2, 3, 4 and Day 84, 112 and 147. ]
  2. Proportion of subjects exhibiting 90% and 75% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) [ Time Frame: Compared from baseline to each study visit, treatment 2, 3, 4 and Day 84, 112 and 147. ]
  3. 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) [ Time Frame: Compared from baseline to each study visit, treatment 2, 3, 4 and Day 84, 112 and 147. ]
  4. Change from baseline in the percent of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) [ Time Frame: Percent change from baseline to each study visit, treatment 2, 3, 4 and Day 84, 112 and 147. ]

Other Outcome Measures:
  1. 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) [ Time Frame: Compared from baseline to each study visit, treatment 2, 3, 4 and Day 84, 112 and 147. ]
  2. 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) [ Time Frame: Complete clearance compared from Day 84 to follow-up days 112 and 147. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Be healthy, immunocompetent males or females ≥ 18 years of age
  • Present with ≥ 2 and ≤ 30 external genital and/or perianal warts in ≥ 1 of the following anatomic areas:

    • In both sexes: medial thigh (except inguinal fold); supra-pubic, perineal, and perianal areas
    • In men: over the glans penis (excluding urethral meatus), penis shaft, scrotum, and foreskin
    • In women: vulva (excluding labia minora and mucosal surfaces)
  • Have warts present for ≥ 4 weeks at the baseline visit
  • Have warts that are ≤ 8 mm in diameter each

Key Exclusion Criteria:

  • Have a wart within the allowed treatment area > 8 mm in diameter or with an eroded or ulcerated surface, in the Investigator's opinion
  • Have an unclear diagnosis of condyloma
  • Have any wart types other than genital warts (e.g., common or plantar warts) that require treatment during the study period
  • Have active genital herpes eruption, or had active genital herpes lesions within 4 weeks before enrollment
  • Have a history of neoplasia or other HPV-associated malignancies within the last 5 years
  • Are systemically immunosuppressed
  • Are sexually active or may become sexually active and are unwilling to practice responsible birth control methods
  • Are pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981822


Contacts
Layout table for location contacts
Contact: Morgan McCafferty, PM 919-433-2644 Morgan.McCafferty@Paidion.com
Contact: Mariana Bui, CTA 919-433-2748 Mariana.Bui@Paidion.com

Locations
Layout table for location information
United States, Indiana
The Indiana Clinical Trials Center,PC Not yet recruiting
Plainfield, Indiana, United States, 46168
Contact: Kimberley Eads, FNP-BC         
Contact: Amanda Rice, CRC    317-837-6082    arice@indianatrials.com   
Principal Investigator: Scott Guenthner, MD         
United States, Louisiana
DelRicht Research Not yet recruiting
Baton Rouge, Louisiana, United States, 70816
Contact: Skyler Deakle, CRC    504-336-2643    sdeakle@delricht.com   
Contact: Kandice Lemoine, CRC    504-336-2643    klemoine@delricht.com   
Principal Investigator: Kevin DiBenedetto, MD         
United States, Michigan
Clarkston Skin Research Not yet recruiting
Clarkston, Michigan, United States, 48346
Contact: Brianna Cole, CRC    248-620-3376 ext 116    bodonnell@clarkstonderm.com   
Contact: Danielle Wilder, CRC    248-620-3376    dwilder@clarkstonderm.com   
Principal Investigator: Wendy McFalda, DO         
United States, Oklahoma
DelRicht Research Not yet recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Marshall Morris, CRC    504-336-2667    mmorris@delricht.com   
Principal Investigator: Melita Tate, MD         
Sponsors and Collaborators
Verrica Pharmaceuticals Inc.
Instat Consulting, Inc.
Paidion Research, Inc.
BioClinica, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Scott Guenthner, MD The Indiana Clinical Trials Center

Layout table for additonal information
Responsible Party: Verrica Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03981822     History of Changes
Other Study ID Numbers: VP-102-104
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Verrica Pharmaceuticals Inc.:
Human Papilloma Virus (HPV)
Genital Warts
Sexually Transmitted Disease (STD)
Viral Disease

Additional relevant MeSH terms:
Layout table for MeSH terms
Warts
Skin Diseases
Sexually Transmitted Diseases
Papillomavirus Infections
Condylomata Acuminata
Communicable Diseases
Infection
Skin Diseases, Infectious
Virus Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases, Viral
DNA Virus Infections
Tumor Virus Infections
Genital Diseases, Male
Genital Diseases, Female