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Cantharidin

Enzyme Inhibitors

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.

VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 14 days between treatments.

VP-102 Cantharidin topical film forming solution

VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 21 days between treatments.

VP-102 Cantharidin, topical film forming solution

Adnan Nasir, MD

Scott Guenthner, MD

This is a Phase 2, open label study (Study number VP-102-105; referred to as COVE-1 \[Cantharidin and Occlusion in Verruca Epithelium\]) to evaluate the efficacy, safety and tolerability of VP-102 treatment in subjects with common warts. This study has two Cohorts.

The first Cohort (Cohort 1) utilizes a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response.Twenty Subjects (2 years and older) are targeted completing End of Study (EOS) visit in Cohort 1.

The second Cohort (Cohort 2) utilizes a treatment interval of 21 days between treatments. Paring of lesions is allowed. Approximately 35 subjects (12 years and older) will be enrolled in Cohort 2. Up to 4 sites will participate in the study.

This study has 2 cohorts. Cohort 1 of the study enrolled 21 subjects and has completed all subject related study activities. Analysis is to be conducted at Day 84. Cohort 2 will utilize 4 sites with an enrollment of approximately 35 subjects. The primary analysis will be conducted at Day 84 with an additional period of follow up out to Day 147.

Cantharidin and Occlusion in Verruca Epithelium

A Phase 2, Open Label Study to Evaluate the Efficacy, Safety and Tolerability of VP-102 in Subjects With Common Warts (Verruca Vulgaris)

Cohort 1: Percent change from baseline in the number of treatable warts (Baseline and new) from Baseline at Visit 2, Visit 3, Visit 4 and over the duration of the study.

Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and the EOS Visit.

Cohort 1: Proportion of subjects exhibiting ≥ 50% clearance of all treatable warts (baseline and new) at the EOS visit as compared to baseline.

Cohort 1-Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOS compared to baseline.

Cohort 1-Proportion of subjects exhibiting reduction of at least 1 treatable wart from baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84).

Cohort 2: Intent to Treat population Cohort 2-Percent reduction of all treatable warts (baseline and new) from baseline at Visit 2, Visit 3, Visit 4 and over duration of the study.

Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4 and the EOT Visit (Day 84).

Cohort 2: Proportion of subjects exhibiting ≥ 50 % clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84) as compared to baseline.

Cohort 2: Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOT compared to baseline.

Cohort 2: Proportion of subjects exhibiting reduction of at least 1 treatable wart from baseline at Visit 2, Visit 3, Visit 4 and at the EOT Visit (Day 84).

Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at follow-up visits on Day 105, Day 126 and Day 147.

Cohort 2: Percent reduction of all treatable warts (baseline and new) from baseline at follow-up visits on Day 105, Day 126 and Day 147.

Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at follow-up visits on Day 105, Day 126 and Day 147.

Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOS Visit (Day 84).

Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84).

Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at the EOS Visit (Day 84).

Cohort 1: Assessing the percent change from Baseline in the number of treatable warts (Baseline and new) at the EOT visit (Day 84).

Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and over the duration of the study.

Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at the EOT Visit Day 84).

Cohort 2: Change from baseline in the percent of treatable warts (baseline and new) at the EOT Visit (Day 84).

Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts, (baseline and new), at Visit 2, Visit 3, Visit 4 and over the duration of the study.

Instat Consulting, Inc.

Paidion Research, Inc.

BioClinica, Inc.

ALMAC Clinical Services

Verrica Pharmaceuticals Inc.

Treatment Emergent Adverse Events (TEAEs) are defined as those AEx that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE was considered treatment emergent. Local skin reactions to treatment were recorded as AEs.

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.

Cohort 1

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. Subjects were 12 years and older.

Cohort 2

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.

Utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed.

VP-102 Cantharidin topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 14 days between treatments.

VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

VP-102 - Cohort 1

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.

Utilized a treatment interval of at least 21 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. Paring of lesions was allowed.

VP-102 Cantharidin topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21days between treatments.

VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

VP-102 - Cohort 2

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Baseline wart count

Study participants enrolled into Cohort 1 were not included in Cohort 2. New subjects were enrolled into Cohort 2.

Susan Cutler, VP, Medical Affairs

Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.

Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed.

VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments.

VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)

Baseline

End of Treatment Visit

Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)

Cohort 1: Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit (Day 84).

Complete Clearance Reported at any Visit?

Complete Clearance Reported at Day 14

Complete Clearance Reported at Day 28

Complete Clearance Reported at Day 42

Complete Clearance Reported at Day 84 (EOS)

Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study

Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit Day 84)

Cohort 2: Change From Baseline in the Percent of Treatable Warts (Baseline and New) at the EOT Visit (Day 84)

Complete Clearance Reported at Day 21 (Treatment Visit 2)

Complete Clearance Reported at Day 42 (Treatment Visit 3)

Complete Clearance Reported at Day 63 (Treatment Visit 4)

Complete Clearance Reported at Day 84 (EOT)

Complete Clearance Reported at Day 105

Complete Clearance Reported at Day 126

Complete Clearance Reported at Day 147

Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts, (Baseline and New), at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study

Treatment Visit 2 Day 14

Treatment Visit 3 Day 28

Treatment Visit 4 Day 42

EOS Day 84

Cohort 1:Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study.

Treatment Visit 2

Treatment Visit 3

Treatment Visit 4

End of Study

Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and the EOS Visit

Cohort 1: Proportion of Subjects Exhibiting ≥ 50% Clearance of All Treatable Warts (Baseline and New) at the EOS Visit as Compared to Baseline

Cohort 1-Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOS Compared to Baseline

Reduction of >= 1 Wart from Baseline at any visit?

Wart Reduction >= 1 Reported at Day 14 (Visit 2)

Wart Reduction >= 1 Reported at Day 28 (Visit 3)

Wart Reduction >= 1 Reported at Day 42 (Visit 4)

Wart Reduction >= 1 Reported at Day 84 (EOS)

Cohort 1-Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84)

Day 21 (Treatment Visit 2)

Day 42 (Treatment Visit 3)

Day 63 (Treatment Visit 4)

Day 84 (End of Treatment Visit)

Cohort 2: Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over Duration of the Study.

Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4 and the EOT Visit (Day 84)

Cohort 2: Proportion of Subjects Exhibiting ≥ 50 % Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84) as Compared to Baseline

Cohort 2: Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOT Compared to Baseline

Cohort 2: Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOT Visit (Day 84)

Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Follow-up Visits on Day 105, Day 126 and Day 147

Day 105

Day 126

Day 147

Cohort 2: Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Follow-up Visits on Day 105, Day 126 and Day 147

Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Follow-up Visits on Day 105, Day 126 and Day 147

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of at least 21 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. Paring of lesions was allowed. Subjects were 12 years and older.

Spots Global Cancer Trial Database for Cantharidin and Occlusion in Verruca Epithelium

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