Study to Determine the Phototoxity of Atralin (Tretinoin) Gel, 0.05%

This study has been completed.

First Received on January 16, 2008. Last Updated on March 26, 2008 History of Changes

Sponsor:	Coria Laboratories, Ltd.
Information provided by:	Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:	NCT00604032

Purpose

To assess the potential of tretnoin gel 0.05% to produce phototoxic reactions, measured as skin reactions 24 and 48 hours after UV radiation of drug on skin.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor)
Official Title:	Clinical Evaluation of the Phototoxic Potential of Atralin (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 sensitization [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Enrollment:	60
Study Start Date:	January 2008
Study Completion Date:	February 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1	Drug: Atralin (tretinoin) Gel, 0.05% Assess potential of tretinoin gel, 0.05% to produce phototoxic reactions, measured 24 and 48 hours after UV radiation of drug on the skin.

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 or older

Exclusion Criteria:

Less than 18 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604032

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 Stanfiled, MS

Suncare Laboratories

More Information

No publications provided

Responsible Party:	D. Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:	NCT00604032 History of Changes
Other Study ID Numbers:	029-066-09-001
Study First Received:	January 16, 2008
Last Updated:	March 26, 2008
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by Coria Laboratories, Ltd.:

Safety when exposed to sunlight

Additional relevant MeSH terms:

Tretinoin
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 09, 2012