Clinical Evaluation of the Photoallergy Potential of Atralin Gel - Full Text View

Sponsored by:	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

Drug Information available for: Tretinoin

U.S. FDA Resources

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%)

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

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
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

Study placed in the following topic categories:

Hypersensitivity
Hypersensitivity, Delayed
Photosensitivity Disorders
Skin Diseases
Dermatitis, Photoallergic
Dermatitis, Allergic Contact

Tretinoin
Skin Diseases, Eczematous
Healthy
Dermatitis, Contact
Dermatitis

Additional relevant MeSH terms:

Keratolytic Agents
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009