Clinical Evaluation of the Photoallergy Potential of Atralin Gel

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Atralin (tretinoin) gel, 0.05%

• Registration Number: NCT00603772
• Lead Sponsor: Coria Laboratories, Ltd.

Brief Summary

To assess the potential of tretinoin gel 0.05% and its vehicle to produce photoallergic reactions, measured as skin reactions following induction and challenge.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-29
• Status Verified: 2008-02
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Last Update Submitted: 2008-05-05
• Last Update Posted: 2008-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Normal, healthy volunteers
• 18 years of age and older

Exclusion Criteria

• Less than 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Atralin (tretinoin) gel, 0.05%	Safety when exposed to sunlight

Primary Outcome Measures

Name	Time	Method
UV Induced skin irritation	4 days

Trial Locations

Locations (1)

Suncare Research Laboratories; 🇺🇸 Winston-Salem, North Carolina, United States