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Clinical Trials/EUCTR2005-002820-32-DE
EUCTR2005-002820-32-DEActive, not recruitingPhase 1

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.

Dow Pharmaceutical Sciences Inc.0 sites107 target enrollmentStarted: August 18, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
107
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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.

Investigators

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A Multi-Center, Double-Blind, Randomized,... | Clinical Trial