A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts
Condition: Condylomata Acuminata; Papillomavirus Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Warts
MeSH terms: Communicable Diseases; Infections; Warts; Sexually Transmitted Diseases; Papillomavirus Infections; Condylomata Acuminata; Skin Diseases, Infectious; Virus Diseases; Sexually Transmitted Diseases, Viral; Skin Diseases, Viral; Skin Diseases
Intervention: VP-102 and applicator; Placebo
Intervention description: 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.; The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin
Intervention MeSH terms: Cantharidin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The aim of Part A is to determine the two best treatment regimens for evaluation of safety and efficacy in Part B. Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups (n=6/group) that will enroll progressively.
Part B of the study will begin enrollment only after the Sponsor has selected the two dose regimens in Part A, which will be called VP-102 Regimen 1 and Regimen 2.Approximately 90 subjects will be enrolled and randomized to one of four treatment arms (two treatment regimens, each with VP-102 and Placebo). Randomization will be stratified by sex so that neither gender exceeds ~60% of any treatment arm. Two of the treatment arms will be VP-102 Regimen 1 and VP-102 Regimen 2. The other two treatment arms will be placebo (Placebo Regimen 1 and Placebo Regimen 2), with corresponding durations of skin exposure matching those selected for VP-102 Regimen 1 and Regimen 2.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human Papilloma Virus (HPV); Genital Warts; Sexually Transmitted Disease (STD); Viral Disease

Summary:

      This is a Phase 2, double-blind, placebo-controlled study to determine the dose regimen,
      safety, tolerability, and efficacy of VP-102 in subjects with External Genital Warts (EGW).
      This study is divided into two parts (Part A and Part B). Increasing durations of skin
      exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups prior
      to progressing to enrollment in Part B. Part A & B will enroll a approximately 108 subjects
      completing 4 treatment applications every 21 days and continuing with follow-up assessments
      at Day 84, 112 and 147.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Be healthy, immunocompetent males or females ≥ 18 years of age

          -  Present with ≥ 2 and ≤ 30 external genital and/or perianal warts in ≥ 1 of the
             following anatomic areas:

               -  In both sexes: medial thigh (except inguinal fold); supra-pubic, perineal, and
                  perianal areas

               -  In men: over the glans penis (excluding urethral meatus), penis shaft, scrotum,
                  and foreskin

               -  In women: vulva (excluding labia minora and mucosal surfaces)

          -  Have warts present for ≥ 4 weeks at the baseline visit

          -  Have warts that are ≤ 8 mm in diameter each

        Key Exclusion Criteria:

          -  Have a wart within the allowed treatment area > 8 mm in diameter or with an eroded or
             ulcerated surface, in the Investigator's opinion

          -  Have an unclear diagnosis of condyloma

          -  Have any wart types other than genital warts (e.g., common or plantar warts) that
             require treatment during the study period

          -  Have active genital herpes eruption, or had active genital herpes lesions within 4
             weeks before enrollment

          -  Have a history of neoplasia or other HPV-associated malignancies within the last 5
             years

          -  Are systemically immunosuppressed

          -  Are sexually active or may become sexually active and are unwilling to practice
             responsible birth control methods

          -  Are pregnant or breastfeeding