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VP-102 and applicator · CARE-1

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

Ensayo de Verrica Pharmaceuticals Inc. en Condylomata Acuminata · Papillomavirus Infections · Skin Diseases, Viral · Skin Diseases, Infectious · Skin Diseases · Sexually Transmitted Diseases, Viral · Sexually Transmitted Diseases · Warts (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

105

previstos

Centros

4

Fin del objetivo primario

may 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jun 2019.

Qué mide

Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. (Compares baseline wart count to Day 84, end of treatment.) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de VRCA

Todos los de VRCA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03981822), actualizada en nov 2024.