Clinical Evaluation of the Photoallergy Potential of Atralin Gel

May 5, 2008 updated by: Coria Laboratories, Ltd.

Clinical Evaluation of the Photoallergy Potential of Atralin Gel (Tretinoin Gel 0.05%)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27106
        • Suncare Research Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Less than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Safety when exposed to sunlight
Drug: Atralin (tretinoin) gel, 0.05%
Assess photoallergic reactions for tretinoin 0.05% and vehicle, measured as skin reactions following induction and challenge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
UV Induced skin irritation
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coria Laboratories, Ltd.

Investigators

  • Principal Investigator: Joseph W Stanfield, MS, Suncare Research Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 29, 2008

Study Record Updates

Last Update Posted (Estimate)

May 6, 2008

Last Update Submitted That Met QC Criteria

May 5, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 029-066-09-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Atralin (tretinoin) gel, 0.05%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe