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Clinical Evaluation of the Photoallergy Potential of Atralin Gel

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ClinicalTrials.gov Identifier: NCT00603772
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : May 6, 2008
Sponsor:
Information provided by:
Coria Laboratories, Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Atralin (tretinoin) gel, 0.05% Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Official Title: Clinical Evaluation of the Photoallergy Potential of Atralin Gel (Tretinoin Gel 0.05%)
Study Start Date : January 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tretinoin

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.




Primary Outcome Measures :
  1. UV Induced skin irritation [ Time Frame: 4 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Less than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: D. Innes Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00603772     History of Changes
Other Study ID Numbers: 029-066-09-002
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: February 2008

Keywords provided by Coria Laboratories, Ltd.:
Tretinoin
exposure to UV light
phototoxicity
Safety when exposed to sunlight

Additional relevant MeSH terms:
Tretinoin
Dermatitis, Photoallergic
Dermatitis, Allergic Contact
Dermatitis, Contact
Dermatitis
Skin Diseases
Photosensitivity Disorders
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents