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

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: NCT00604032
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : March 28, 2008
Sponsor:
Information provided by:
Coria Laboratories, Ltd.

Study Description
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Brief Summary:
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 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)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Official Title: Clinical Evaluation of the Phototoxic Potential of Atralin (Tretinoin) Gel, 0.05%
Study Start Date : January 2008
Actual Primary Completion Date : January 2008
Actual Study Completion Date : February 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
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.


Outcome Measures
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Primary Outcome Measures :
  1. UV induced skin sensitization [ 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 or 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): NCT00604032


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 Stanfiled, MS Suncare Laboratories
More Information
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Responsible Party: D. Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00604032    
Other Study ID Numbers: 029-066-09-001
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: February 2008
Keywords provided by Coria Laboratories, Ltd.:
Safety when exposed to sunlight
Additional relevant MeSH terms:
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Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents