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

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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.

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 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

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.




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

Responsible Party: D. Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00604032     History of Changes
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:
Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents