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| Name | Class |
|---|---|
| Instat Consulting, Inc. | OTHER |
| Paidion Research, Inc. | INDUSTRY |
| BioClinica, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Part B & A: VP-102 6 hour-Active | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VP-102 and applicator | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Compares baseline wart count to Day 84, end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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:
Have warts present for ≥ 4 weeks at the baseline visit
Have warts that are ≤ 8 mm in diameter each
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Guenthner, MD | The Indiana Clinical Trials Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Indiana Clinical Trials Center,PC | Plainfield | Indiana | 46168 | United States | ||
| DelRicht Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34515985 | Derived | 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. |
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All subject numbers are based on ITT population. Participants in Part A 6-hour and 24-hour group were also included in Part B subject populations.
2 groups from Part A were to be included in Part B based on Part A analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: VP-102 2-hour | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2019 | May 5, 2021 |
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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.
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Double-blind
Part 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 | Part B, Placebo will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments. |
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| 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. |
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| 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. |
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| Placebo | Combination Product | The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin |
|
| 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). | 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). | 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. | 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). | Percent change from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147. |
| 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). | 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). | 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). | Baseline to Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) |
| Baton Rouge |
| Louisiana |
| 70816 |
| United States |
| Clarkston Skin Research | Clarkston | Michigan | 48346 | United States |
| DelRicht Research | Tulsa | Oklahoma | 74133 | United States |
| Part A: VP-102 6-hour Group |
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. |
| FG002 | Part A: VP-102 24-hour Group | 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. |
| FG003 | Part A: Placebo | This includes 3 subjects that received placebo (1 each for the 2-hour; 6-hour and 24-hour) |
| FG004 | Part B: VP-102 6-hour | VP-102 and applicator: 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. |
| FG005 | Part B: Placebo 6-hour | Placebo and applicator: 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. |
| FG006 | Part B: VP-102 24-hour | VP-102 and applicator: 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. |
| FG007 | Part B: Placebo 24-hour | Placebo and applicator: 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. |
| COMPLETED |
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| NOT COMPLETED |
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ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: VP-102 2-hour | VP-102 will be applied for 2-hours and removed. VP-102 is applied every 21 days for 4 treatments. |
| BG001 | Part A: VP-102 6-hour | VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments. |
| BG002 | Part A: VP-102 24-hour | VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments. |
| BG003 | Part A: Placebo | Placebo will be applied for 2-,6- or 12-hours and removed. Placebo is applied every 21 days for 4 treatments. |
| BG004 | Part B: VP-102 6-hour | VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments. |
| BG005 | Part B: 6-hour-Placebo | Placebo will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments. |
| BG006 | Part B: VP-102 24-hour | VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments. |
| BG007 | Part B: 24-hour-Placebo | Placebo will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline number of treatable external genital warts | Mean | Standard Deviation | genital warts |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Part B and A: Intent-to-Treat Population. Part B summary is pooled with its respective treatments from Part A. | Posted | Count of Participants | Participants | Compares baseline wart count to Day 84, end of treatment. |
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| Secondary | 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). | Part B and A pooled - ITT population | Posted | Count of Participants | Participants | Clearance compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147. |
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| Secondary | 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). | ITT Population | Posted | Count of Participants | Participants | Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147. |
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| Secondary | 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). | ITT Population | Posted | Count of Participants | Participants | Compared from baseline to each study visit, treatment 2, (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147. |
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| Secondary | 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. | ITT Populations | Posted | Mean | Standard Deviation | Warts | Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147. |
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| Secondary | 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). | ITT Population | Posted | Mean | Standard Deviation | Wart percentage change from Baseline | Percent change from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147. |
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| Other Pre-specified | 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). | ITT population | Posted | Count of Participants | Participants | Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147. |
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| Other Pre-specified | 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). | ITT Population | Posted | Count of Participants | Participants | Complete clearance compared from Day 84 to follow-up days 112 and 147. |
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| Other Pre-specified | 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). | ITT Population | Posted | Mean | Standard Deviation | mm^2 | Baseline to Study Day 84, Follow-up Visits at Days 112 and 147 (EOS) |
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| Other Pre-specified | 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). | ITT Population | Posted | Mean | Standard Deviation | Change from baseline in % of wart area | Baseline to Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) |
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Adverse Events (AEs) were collected following the first application of study drug through Study Day 147.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part B Pooled With Part A: VP-102 6-hour | Data will be summarized for both Part B pooled with Part A for the applicable treatments. | 0 | 29 | 1 | 29 | 29 | 29 |
| EG001 | Part B Pooled With Part A: Placebo 6-hour | Data will be summarized for both Part B pooled with Part A for the applicable treatments. | 0 | 22 | 1 | 22 | 15 | 22 |
| EG002 | Part B Pooled With Part A VP-102 24-hour | Data will be summarized for both Part B pooled with Part A for the applicable treatments. | 0 | 28 | 0 | 28 | 28 | 28 |
| EG003 | Part B Pooled With Part A: Placebo 24-hour | Data will be summarized for both Part B pooled with Part A for the applicable treatments. | 0 | 20 | 1 | 20 | 9 | 20 |
| EG004 | Part A: VP-102 2-hour | Data summarized for VP-102 2-hour group. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG005 | Part A: Placebo 2-hour | Data summarized for VP-102 2-hour group.. | 0 | 1 | 0 | 1 | 0 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site vesicles | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Application site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Application site scab | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Application site discolouration | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Application site dryness | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Application site erosion | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Application site oedema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Application site exfoliation | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Umbilical hernia repair | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
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.
PI is bound to terms and conditions of a Sponsored Clinical Trial Agreement which has strict confidentiality obligations running to Sponsor and broad provisions restricting PI's rights to publish or present any data or Study Results without Sponsor's express review consent and review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Cutler, VP, Medical Affairs | Verrica Pharmaceuticals | 484-773-0898 | scutler@verrica.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2019 | May 5, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| D030361 | Papillomavirus Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D014860 | Warts |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722901 | VP-102 |
| D002193 | Cantharidin |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No |
|
| Cochran-Mantel-Haenszel |
| 0.0075 |
P-value is based on the CMH test stratified by gender. |
| Superiority |
| Part B Pooled With Part A: 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: 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: Placebo 24-hour |
Data will be summarized for both Part B pooled with Part A for the applicable treatments. |
|
|
|
| OG003 | Part B Pooled With Part A: Placebo 24-hour | Data will be summarized for both Part B pooled with Part A for the applicable treatments. |
|
|
|
| OG003 |
| Part B Pooled With Part A: 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: Placebo 24-hour |
Data will be summarized for both Part B pooled with Part A for the applicable treatments. |
|
|
|
Data will be summarized for both Part B pooled with Part A for the applicable treatments. |
|
|
|
|
|
|
Data will be summarized for both Part B pooled with Part A for the applicable treatments. |
|
|
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
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