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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002820-32-DE

Enrollment

105

Registered

2005-08-18

Start date

2005-12-08

Completion date

Unknown

Last updated

2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

common warts

Interventions

Product Name: IDP-102 Gel 5 % Product Code: IDP-102 Gel 5 % Pharmaceutical Form: Gel Current Sponsor code: IDP-102 Other descriptive name: tetraethylammonium chloride (TEAC) Concentration unit: % per

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026