Condylomata AcuminataPhase 2CARE-1NCT03981822

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

A Phase 2 study testing VP-102 and applicator in people with Condylomata Acuminata and Papillomavirus Infections, run by Verrica Pharmaceuticals Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Condylomata Acuminata, Papillomavirus Infections, Skin Diseases, Viral
What is being tested?: VP-102 and applicator
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 105 participants
Where: 4 sitesUnited States
Study dates: 25 Jun 2019to 8 Jul 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

DelRicht Research
Baton Rouge, Louisiana, 70816
Clarkston Skin Research
Clarkston, Michigan, 48346
The Indiana Clinical Trials Center,PC
Plainfield, Indiana, 46168
DelRicht Research
Tulsa, Oklahoma, 74133

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Condylomata Acuminata, Papillomavirus Infections, Skin Diseases, Viral, Skin Diseases, Infectious, Skin Diseases, Sexually Transmitted Diseases, Viral
Being tested: VP-102 and applicator, Placebo
Keywords: Human Papilloma Virus (HPV), Genital Warts, Sexually Transmitted Disease (STD), Viral Disease
Medical subject headings: Condylomata Acuminata, Papillomavirus Infections, Skin Diseases, Viral, Skin Diseases, Infectious, Skin Diseases, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Warts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VP-102 and applicatorCombination product
Also called VP-102 (cantharidin) 0.7% w/v topical solution
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.
PlaceboCombination product
The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin

Study groups in NCT03981822
Study group	Role	What they receive
Part A: VP-102 2 hour-Active	Active comparator	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. Receives: Combination Product: VP-102 and applicator
Part A: VP-102 6-hour Active	Active comparator	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. Receives: Combination Product: VP-102 and applicator
Part A: VP-102 24-hour Active	Active comparator	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. Receives: Combination Product: VP-102 and applicator
Part A: Placebo	Placebo comparator	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. Receives: Combination Product: Placebo
Part B & A: VP-102 6 hour-Active	Active comparator	Part B, VP-102 will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments. Receives: Combination Product: VP-102 and applicator
Part B & A: 6-hour-Placebo	Placebo comparator	Part B, Placebo will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments. Receives: Combination Product: Placebo
Part B & A: VP-102 24-hour Active	Active comparator	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. Receives: Combination Product: VP-102 and applicator
Part B & A: 24-hour-Placebo	Placebo comparator	Part B, VP-Placebo will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments. Receives: Combination Product: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.
Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.
Measured: Compares baseline wart count to Day 84, end of treatment.

Secondary outcomes (5)

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 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).
Measured: Clearance compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
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 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).
Measured: Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
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)
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).
Measured: Compared from baseline to each study visit, treatment 2, (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
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)
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.
Measured: Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
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)
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).
Measured: Percent change from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jun 20198 Jul 2020

First posted11 Jun 2019
Study start25 Jun 2019
Primary completion21 May 2020
Study completion8 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Condylomata AcuminataStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03981822
Sponsor's protocol ID: VP-102-104
Acronym: CARE-1
Status last verified: Aug 2021
First submitted: 6 Jun 2019
Last updated: 27 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Guenthner S, McFalda W, Tate M, Eads K, Rieger J, Glover DK, Willson C, Rumney P, Rosen T, Andres J, Olivadoti M. Phase II, Double-Blind, Vehicle-Controlled Study to Determine the Cantharidin Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects with External Genital Warts. Am J Clin Dermatol. 2021 Nov;22(6):867-875. doi: 10.1007/s40257-021-00635-2. Epub 2021 Sep 13.
PubMed 34515985

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
RecruitingPhase 2
To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years
HPV Infection, HPV-Related Carcinoma
Active, not recruitingPhase 3
Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
Cervical Intraepithelial Neoplasia, Cervical Cancer
Active, not recruitingPhase 3
A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males
Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia

All Condylomata Acuminata trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03981822
Acronym / sponsor ID: CARE-1 / VP-102-104
Conditions: Condylomata Acuminata, Papillomavirus Infections, Skin Diseases, Viral, Skin Diseases, Infectious, Skin Diseases, Sexually Transmitted Diseases, Viral
Keywords: Human Papilloma Virus (HPV), Genital Warts, Sexually Transmitted Disease (STD), Viral Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Verrica Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Collaborators: Instat Consulting, Inc., Paidion Research, Inc., BioClinica, Inc.
Study start: 25 Jun 2019 (actual)
Primary completion: 21 May 2020 (actual)
Study completion: 8 Jul 2020 (actual)
First posted: 11 Jun 2019 (actual)
Results: Posted 22 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8
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.

Arm	Type	Receives
Part A: VP-102 2 hour-Active	Active comparator	Combination Product: VP-102 and applicatorFor 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.
Part A: VP-102 6-hour Active	Active comparator	Combination Product: VP-102 and applicatorFor 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.
Part A: VP-102 24-hour Active	Active comparator	Combination Product: VP-102 and applicatorFor 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.
Part A: Placebo	Placebo comparator	Combination Product: PlaceboFor 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 & A: VP-102 6 hour-Active	Active comparator	Combination Product: VP-102 and applicatorPart B, VP-102 will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.
Part B & A: 6-hour-Placebo	Placebo comparator	Combination Product: PlaceboPart B, Placebo will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.
Part B & A: VP-102 24-hour Active	Active comparator	Combination Product: VP-102 and applicatorFor 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 & A: 24-hour-Placebo	Placebo comparator	Combination Product: PlaceboPart B, VP-Placebo will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:
Have warts present for ≥ 4 weeks at the baseline visit
Have warts that are ≤ 8 mm in diameter each

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VP-102 and applicatorAlso: VP-102 (cantharidin) 0.7% w/v topical solutionIn 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.	Combination product	Part A: VP-102 2 hour-Active, Part A: VP-102 24-hour Active, Part A: VP-102 6-hour Active, Part B & A: VP-102 24-hour Active, Part B & A: VP-102 6 hour-Active
PlaceboThe placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin	Combination product	Part A: Placebo, Part B & A: 24-hour-Placebo, Part B & A: 6-hour-Placebo

Primary outcome

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

5 secondary outcomes

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 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
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)
Time frame: Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
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)
Time frame: Compared from baseline to each study visit, treatment 2, (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
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 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
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)
Time frame: Percent change from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

Results and safety

Results posted to the registry on 22 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: VP-102 2-hour	5	5
Part A: VP-102 6-hour Group	5	3
Part A: VP-102 24-hour Group	5	4
Part A: Placebo	3	3
Part B: VP-102 6-hour	25	17
Part B: Placebo 6-hour	23	17
Part B: VP-102 24-hour	22	16
Part B: Placebo 24-hour	17	12

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Part B Pooled With Part A: VP-102 6-hour n = 30	Part B Pooled With Part A: Placebo 6-hour n = 24	Part B Pooled With Part A VP-102 24-hour n = 27	Part B Pooled With Part A: Placebo 24-hour n = 18
Yes	11	1	9	0
No	19	23	18	18

Part B Pooled With Part A: VP-102 6-hour vs Part B Pooled With Part A: Placebo 6-hour: p = 0.0048, Cochran-Mantel-Haenszel
Part B Pooled With Part A VP-102 24-hour vs Part B Pooled With Part A: Placebo 24-hour: p = 0.0075, Cochran-Mantel-Haenszel

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

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected following the first application of study drug through Study Day 147.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part B Pooled With Part A: VP-102 6-hour	1 of 29 (3.4%)	29 of 29 (100%)	0 of 29
Part B Pooled With Part A: Placebo 6-hour	1 of 22 (4.5%)	15 of 22 (68.2%)	0 of 22
Part B Pooled With Part A VP-102 24-hour	0 of 28 (0%)	28 of 28 (100%)	0 of 28
Part B Pooled With Part A: Placebo 24-hour	1 of 20 (5%)	9 of 20 (45%)	0 of 20
Part A: VP-102 2-hour	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Part A: Placebo 2-hour	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34515985Guenthner S, McFalda W, Tate M, Eads K, Rieger J, Glover DK, Willson C, Rumney P, Rosen T, Andres J, Olivadoti M. Phase II, Double-Blind, Vehicle-Controlled Study to Determine the Cantharidin Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects with External Genital Warts. Am J Clin Dermatol. 2021 Nov;22(6):867-875. doi: 10.1007/s40257-021-00635-2. Epub 2021 Sep 13.
Individual participant dataSharing planned: No

Related trials for Condylomata Acuminata

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott Guenthner, MD principal investigator

The Indiana Clinical Trials Center

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VP-102 and applicator in people with Condylomata Acuminata and Papillomavirus Infections, run by Verrica Pharmaceuticals Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03981822, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.