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Clinical Evaluation of the Photoallergy Potential of Atralin Gel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Description
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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 Design
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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

Arms and Interventions
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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.


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

Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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
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United States, North Carolina
Suncare Research Laboratories
Winston-Salem, North Carolina, United States, 27106
Sponsors and Collaborators
Coria Laboratories, Ltd.
Investigators
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Principal Investigator: Joseph W Stanfield, MS Suncare Research Laboratories
More Information
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Responsible Party: D. Innes Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00603772    
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:
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Dermatitis, Photoallergic
Dermatitis, Allergic Contact
Dermatitis, Contact
Dermatitis
Skin Diseases
Photosensitivity Disorders
Skin Diseases, Eczematous
 Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases
Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents