A Phase 2 interventional study of VP-102 and applicator and Placebo in Condylomata Acuminata, Papillomavirus Infections and Skin Diseases, Viral, sponsored by Verrica Pharmaceuticals Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Verrica Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment
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.
116 studies on the registry are indexed under Condylomata Acuminata; 11 are open to participants now.
This study's enrollment of 105 is below the median of 158 across 95 interventional studies indexed under Condylomata Acuminata.
Browse Condylomata Acuminata studies →Verrica Pharmaceuticals Inc. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Present with ≥ 2 and ≤ 30 external genital and/or perianal warts in ≥ 1 of the following anatomic areas:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Combination Product: VP-102 and applicator
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.
Combination Product: VP-102 and applicator
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.
Combination Product: Placebo
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
Part B, Placebo will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.
Combination Product: Placebo
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
Part B, VP-Placebo will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments.
Combination Product: Placebo
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.
Also known as: VP-102 (cantharidin) 0.7% w/v topical solution
The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin
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.
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 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).
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)
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)
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)
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.
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)
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.
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 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 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
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)
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).
Time frame: Complete clearance compared from Day 84 to follow-up days 112 and 147.
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)
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).
Time frame: Baseline to Study Day 84, Follow-up Visits at Days 112 and 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)
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).
Time frame: Baseline to Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
2 groups from Part A were to be included in Part B based on Part A analysis.
| Milestone | Part A: VP-102 2-hour | Part A: VP-102 6-hour Group | Part A: VP-102 24-hour Group | Part A: Placebo | Part B: VP-102 6-hour | Part B: Placebo 6-hour | Part B: VP-102 24-hour | Part B: Placebo 24-hour |
|---|---|---|---|---|---|---|---|---|
| Started | 5 | 5 | 5 | 3 | 25 | 23 | 22 | 17 |
| Completed | 5 | 3 | 4 | 3 | 17 | 17 | 16 | 12 |
| Not completed | 0 | 2 | 1 | 0 | 8 | 6 | 6 | 5 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 | 0 | 6 | 4 | 4 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 2 |
| Withdrew: Covid-19 related | 0 | 0 | 0 | 0 | 2 | 1 | 2 | 1 |
Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.
| Participants | 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 |
|---|---|---|---|---|
| Yes | 11 | 1 | 9 | 0 |
| No | 19 | 23 | 18 | 18 |
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).
| Participants | 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 |
|---|---|---|---|---|
| Treatment Visit 2: Yes, Complete Clearance | 1 | 0 | 4 | 0 |
| Treatment Visit 3: Yes, Complete Clearance | 4 | 0 | 8 | 2 |
| Treatment Visit 4: Yes, Complete Clearance | 6 | 0 | 7 | 0 |
| Study Day 84 EOT: Yes, Complete Clearance | 11 | 1 | 9 | 0 |
| F/U Visit Day 112: Yes, Complete Clearance | 9 | 2 | 8 | 2 |
| F/U Visit Day 147: Yes, Complete Clearance | 6 | 3 | 8 | 2 |
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).
| Participants | 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 |
|---|---|---|---|---|
| Treatment Visit 2: Incidence of >=90% Clearance: YES | 1 | 0 | 4 | 0 |
| Treatment Visit 3: Incidence of >=90% Clearance: YES | 5 | 0 | 8 | 2 |
| Treatment Visit 4: Incidence of >=90% Clearance: YES | 7 | 0 | 7 | 0 |
| Study Day 84 EOT: Incidence of >=90% Clearance: YES | 14 | 2 | 11 | 0 |
| F/U Visit Day 112: Incidence of >=90% Clearance: YES | 11 | 2 | 9 | 2 |
| F/U Visit Day 147: Incidence of >=90% Clearance: YES | 9 | 3 | 9 | 2 |
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).
| Participants | 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 |
|---|---|---|---|---|
| Treatment Visit 2: Incidence of >=75% Clearance: YES | 5 | 0 | 6 | 1 |
| Treatment Visit 3: Incidence of >=75% Clearance: YES | 8 | 0 | 14 | 2 |
| Treatment Visit 4: Incidence of >=75% Clearance: YES | 11 | 2 | 12 | 1 |
| Study Day 84 EOT: Incidence of >=75% Clearance: YES | 15 | 2 | 15 | 2 |
| F/U Visit Day 112: Incidence of >=75% Clearance: YES | 13 | 3 | 13 | 3 |
| F/U Visit Day 147: Incidence of >=75% Clearance: YES | 10 | 4 | 13 | 2 |
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.
| Warts | 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 |
|---|---|---|---|---|
| Treatment Visit 2 | -4.0 ± 4.95 | -0.3 ± 1.11 | -5.3 ± 4.25 | 0.6 ± 30.07 |
| Treatment Visit 3 | -4.4 ± 5.80 | -1.1 ± 3.69 | -6.3 ± 5.45 | -0.5 ± 5.01 |
| Treatment Visit 4 | -5.2 ± 4.72 | -0.9 ± 3.98 | -7.1 ± 5.09 | 0.5 ± 5.17 |
| Study Day 84 EOT Visit | -6.1 ± 5.24 | -1.1 ± 4.92 | -7.4 ± 6.37 | 0.1 ± 5.12 |
| Follow up Day 112 | -5.3 ± 5.21 | -1.1 ± 5.33 | -8.1 ± 5.54 | -0.3 ± 4.39 |
| Follow-up Visit Day 147 EOS | -5.0 ± 7.63 | -1.2 ± 5.49 | -7.9 ± 5.46 | -0.1 ± 4.66 |
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).
| Wart percentage change from Baseline | 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 |
|---|---|---|---|---|
| Treatment Visit 2 | -41.4 ± 32.38 | -6.2 ± 13.14 | -58.5 ± 26.69 | -2.6 ± 30.07 |
| Treatment Visit 3 | -49.0 ± 37.18 | -8.9 ± 44.46 | -69.3 ± 34.03 | -17.8 ± 49.79 |
| Treatment Visit 4 | -65.8 ± 30.69 | -5.1 ± 66.26 | -77.3 ± 26.87 | 0.6 ± 41.94 |
| Study Day 84 End of Treatment Visit | -79.7 ± 34.27 | -1.6 ± 78.34 | -77.1 ± 38.66 | -5.5 ± 47.98 |
| Follow up Day 112 | -68.2 ± 43.20 | 1.9 ± 91.11 | -79.2 ± 28.36 | -14.2 ± 49.60 |
| Follow up Visit Day 147 End of Study | -42.5 ± 111.83 | -6.0 ± 86.56 | -79.6 ± 25.01 | -12.9 ± 50.49 |
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).
| Participants | 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 |
|---|---|---|---|---|
| Treatment Visit 2 — Yes - at least 1 wart reduction from Baseline | 22 | 6 | 23 | 6 |
| Treatment Visit 2 — No | 8 | 18 | 4 | 12 |
| Treatment Visit 3 — Yes - at least 1 wart reduction from Baseline | 20 | 10 | 21 | 7 |
| Treatment Visit 3 — No | 10 | 14 | 6 | 11 |
| Treatment Visit 4 — Yes - at least 1 wart reduction from Baseline | 23 | 10 | 17 | 4 |
| Treatment Visit 4 — No | 7 | 14 | 10 | 14 |
| Study Day 84 EOT Visit — Yes - at least 1 wart reduction from Baseline | 19 | 9 | 18 | 4 |
| Study Day 84 EOT Visit — No | 11 | 15 | 9 | 14 |
| F/U Visit Day 112 — Yes - at least 1 wart reduction from Baseline | 17 | 10 | 18 | 5 |
| F/U Visit Day 112 — No | 13 | 14 | 9 | 13 |
| F/U Visit Day 147 EOS — Yes - at least 1 wart reduction from Baseline | 13 | 8 | 19 | 5 |
| F/U Visit Day 147 EOS — No | 17 | 16 | 8 | 13 |
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).
| Participants | 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 |
|---|---|---|---|---|
| Yes | 5 | 0 | 7 | 0 |
| No | 25 | 24 | 20 | 18 |
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).
| mm^2 | 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 |
|---|---|---|---|---|
| Study Day 84 (EOT) | -52.60 ± 67.067 | -23.64 ± 59.722 | -72.87 ± 91.659 | 1.60 ± 33.796 |
| Follow-up Day 112 | -79.43 ± 99.679 | -20.35 ± 53.289 | -82.79 ± 71.750 | 1.40 ± 39.963 |
| Follow-up Visit Day 147 (EOS) | -59.28 ± 100.988 | -6.02 ± 36.929 | -68.78 ± 68.710 | 2.21 ± 45.035 |
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).
| Change from baseline in % of wart area | 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 |
|---|---|---|---|---|
| Study Day 84 (EOT) | -46.0 ± 52.77 | -22.3 ± 57.92 | -64.2 ± 55.78 | -7.3 ± 93.42 |
| Follow-up Day 112 | -48.2 ± 54.67 | -21.5 ± 64.54 | -76.4 ± 12.33 | 13.8 ± 129.61 |
| Follow-up Day 147 (EOS) | -45.8 ± 71.37 | -11.7 ± 52.52 | -69.3 ± 16.44 | 19.9 ± 138.49 |
Collected over Adverse Events (AEs) were collected following the first application of study drug through Study Day 147.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part B Pooled With Part A: VP-102 6-hour | 0/29 (0%) | 1/29 (3.4%) | 29/29 (100%) |
| Part B Pooled With Part A: Placebo 6-hour | 0/22 (0%) | 1/22 (4.5%) | 15/22 (68.2%) |
| Part B Pooled With Part A VP-102 24-hour | 0/28 (0%) | 0/28 (0%) | 28/28 (100%) |
| Part B Pooled With Part A: Placebo 24-hour | 0/20 (0%) | 1/20 (5%) | 9/20 (45%) |
| Part A: VP-102 2-hour | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Part A: Placebo 2-hour | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | 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 | Part A: Placebo 2-hour |
|---|---|---|---|---|---|---|
| PneumoniaInfections and infestations | 0/29 | 0/22 | 0/28 | 1/20 | 0/5 | 0/1 |
| Bipolar disorderPsychiatric disorders | 0/29 | 1/22 | 0/28 | 0/20 | 0/5 | 0/1 |
| Musculoskeletal chest painMusculoskeletal and connective tissue disorders | 1/29 | 0/22 | 0/28 | 0/20 | 0/5 | 0/1 |
| Event | 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 | Part A: Placebo 2-hour |
|---|---|---|---|---|---|---|
| Application site vesiclesGeneral disorders | 25/29 | 0/22 | 26/28 | 1/20 | 4/5 | 0/1 |
| Application site painGeneral disorders | 20/29 | 3/22 | 19/28 | 4/20 | 4/5 | 0/1 |
| Application site discolourationGeneral disorders | 7/29 | 4/22 | 6/28 | 0/20 | 4/5 | 0/1 |
| Application site erosionGeneral disorders | 6/29 | 0/22 | 7/28 | 0/20 | 4/5 | 0/1 |
| Application site erythemaGeneral disorders | 14/29 | 3/22 | 19/28 | 1/20 | 2/5 | 0/1 |
| Application site oedemaGeneral disorders | 3/29 | 1/22 | 7/28 | 1/20 | 3/5 | 0/1 |
| Application site scabGeneral disorders | 13/29 | 1/22 | 14/28 | 0/20 | 1/5 | 0/1 |
| Application site pruritusGeneral disorders | 14/29 | 5/22 | 10/28 | 1/20 | 1/5 | 0/1 |
| Application site drynessGeneral disorders | 7/29 | 2/22 | 6/28 | 1/20 | 1/5 | 0/1 |
| Application site exfoliationGeneral disorders | 3/29 | 2/22 | 5/28 | 0/20 | 1/5 | 0/1 |
ITT population
| Age, Continuous(years) | Part A: VP-102 2-hour | Part A: VP-102 6-hour | Part A: VP-102 24-hour | Part A: Placebo | Part B: VP-102 6-hour | Part B: 6-hour-Placebo | Part B: VP-102 24-hour | Part B: 24-hour-Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 34.40 ± 9.915 | 43.00 ± 8.246 | 33.80 ± 5.263 | 32.00 ± 3.606 | 38.12 ± 10.138 | 35.87 ± 7.973 | 34.45 ± 7.526 | 33.88 ± 6.470 | 35.85 ± 8.260 |
| Sex: Female, Male(Participants) | Part A: VP-102 2-hour | Part A: VP-102 6-hour | Part A: VP-102 24-hour | Part A: Placebo | Part B: VP-102 6-hour | Part B: 6-hour-Placebo | Part B: VP-102 24-hour | Part B: 24-hour-Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 4 | 3 | 2 | 0 | 10 | 10 | 10 | 7 | 46 |
| Male | 1 | 2 | 3 | 3 | 15 | 13 | 12 | 10 | 59 |
| Ethnicity (NIH/OMB)(Participants) | Part A: VP-102 2-hour | Part A: VP-102 6-hour | Part A: VP-102 24-hour | Part A: Placebo | Part B: VP-102 6-hour | Part B: 6-hour-Placebo | Part B: VP-102 24-hour | Part B: 24-hour-Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 0 | 6 | 1 | 2 | 5 | 15 |
| Not Hispanic or Latino | 4 | 5 | 5 | 3 | 19 | 22 | 20 | 12 | 90 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Part A: VP-102 2-hour | Part A: VP-102 6-hour | Part A: VP-102 24-hour | Part A: Placebo | Part B: VP-102 6-hour | Part B: 6-hour-Placebo | Part B: VP-102 24-hour | Part B: 24-hour-Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 1 | 0 | 6 | 8 | 1 | 6 | 24 |
| White | 3 | 5 | 3 | 3 | 19 | 12 | 21 | 11 | 77 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 3 |
| Region of Enrollment(participants) | Part A: VP-102 2-hour | Part A: VP-102 6-hour | Part A: VP-102 24-hour | Part A: Placebo | Part B: VP-102 6-hour | Part B: 6-hour-Placebo | Part B: VP-102 24-hour | Part B: 24-hour-Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| United States | 5 | 5 | 5 | 3 | 25 | 23 | 22 | 17 | 105 |
| Baseline number of treatable external genital warts(genital warts) | Part A: VP-102 2-hour | Part A: VP-102 6-hour | Part A: VP-102 24-hour | Part A: Placebo | Part B: VP-102 6-hour | Part B: 6-hour-Placebo | Part B: VP-102 24-hour | Part B: 24-hour-Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 7 ± 5.568 | 9.60 ± 12.012 | 13.00 ± 8.276 | 11.67 ± 12.423 | 8.28 ± 6.380 | 5.87 ± 3.684 | 8.68 ± 5.489 | 7.76 ± 6.897 | 8.08 ± 6.395 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Verrica Pharmaceuticals Inc.