Clinical Evaluation of the Photoallergy Potential of Atralin Gel

This study has been completed.

First Received: January 8, 2008 Last Updated: May 5, 2008 History of Changes

Sponsor:	Coria Laboratories, Ltd.
Information provided by:	Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:	NCT00603772

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Atralin (tretinoin) gel, 0.05%	Phase I

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Single Group Assignment
Official Title:	Clinical Evaluation of the Photoallergy Potential of Atralin Gel (Tretinoin Gel 0.05%)

Resource links provided by NLM:

Drug Information available for: Tretinoin

U.S. FDA Resources

Further study details as provided by Coria Laboratories, Ltd.:

Primary Outcome Measures:

UV Induced skin irritation [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	January 2008
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Normal, healthy volunteers
18 years of age and older

Exclusion Criteria:

Less than 18 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603772

Locations

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

Sponsors and Collaborators

Coria Laboratories, Ltd.

Investigators

Principal Investigator:

Joseph W Stanfield, MS

Suncare Research Laboratories

More Information

No publications provided

Responsible Party:	Coria Laboratories, Ltd. ( D. Innes Cargill, PhD )
Study ID Numbers:	029-066-09-002
Study First Received:	January 8, 2008
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00603772 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Coria Laboratories, Ltd.:

Tretinoin
exposure to UV light
phototoxicity
Safety when exposed to sunlight

Additional relevant MeSH terms:

Skin Diseases
Photosensitivity Disorders
Immune System Diseases
Antineoplastic Agents
Dermatitis, Contact
Pharmacologic Actions
Keratolytic Agents
Hypersensitivity

Hypersensitivity, Delayed
Therapeutic Uses
Dermatitis, Photoallergic
Dermatitis, Allergic Contact
Skin Diseases, Eczematous
Tretinoin
Dermatologic Agents
Dermatitis

ClinicalTrials.gov processed this record on November 27, 2009