A Multi-Center, Double-Blind, Randomized, Dose-Ranging Study of the Safety and Efficacy of IDP-102 Gel 5 %, and 15 % Compared with Vehicle in the Treatment of Common Warts.

Phase 1

• Conditions: common warts

• Registration Number: EUCTR2005-002820-32-DE
• Lead Sponsor: Dow Pharmaceutical Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-18
• Study Completion: 2006-08-15
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Males or females, 18 to 75 years of age.
Clinical diagnosis of common warts (non plantar and non-subungual).
At least 2 but not more than 15 common warts (minimum total wart area of 16 mm2).
Willing and able to provide verbal and written informed consent.
Women of childbearing age must have a negative pregnancy test and must be using a highly effective method of birth control (failure rate < 1 %).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects must not be pregnant or lactating.
Dermatosis in the vicinity of the warts that could interfere with clinical evaluations.
Current immunosuppressive diseases or medication.
History of a hypersensitivity to any ingredients in IDP-102 Gel listed in appendix A of the protocol.
Subjects using a medication whose mechanism of action involves ganglionic blocking agents should be excluded.
Any wart treatment or treatment with any investigational drugs within 30 days of the day 1 Visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To define the optimal concentration of IDP-102 Gel 5 %, and 15 % compared to vehicle when applied to common warts, for up to 12 weeks of treatment. ;Secondary Objective: Results from this study will be used to determine the power and design of the Phase III study and to assess commercial viability.;Primary end point(s): Primary efficacy endpoint: percentage of the total number of baseline warts that clear.