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Sponsored by: |
Coria Laboratories, Ltd. |
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Information provided by: | Coria Laboratories, Ltd. |
ClinicalTrials.gov Identifier: | NCT00603772 |
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%) |
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
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Drug: Atralin (tretinoin) gel, 0.05%
Assess photoallergic reactions for tretinoin 0.05% and vehicle, measured as skin reactions following induction and challenge.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Suncare Research Laboratories | |
Winston-Salem, North Carolina, United States, 27106 |
Principal Investigator: | Joseph W Stanfield, MS | Suncare Research Laboratories |
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 |
Tretinoin exposure to UV light phototoxicity Safety when exposed to sunlight |
Hypersensitivity Hypersensitivity, Delayed Photosensitivity Disorders Skin Diseases Dermatitis, Photoallergic Dermatitis, Allergic Contact |
Tretinoin Skin Diseases, Eczematous Healthy Dermatitis, Contact Dermatitis |
Keratolytic Agents Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Dermatologic Agents Pharmacologic Actions |