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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604032
First Posted: January 29, 2008
Last Update Posted: March 28, 2008
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.
Information provided by:
Coria Laboratories, Ltd.
  Purpose
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 Intervention Phase
Healthy Drug: Atralin (tretinoin) Gel, 0.05% Phase 1

Study Type: Interventional
Study Design: 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%

Resource links provided by NLM:


Further study details as provided by Coria Laboratories, Ltd.:

Primary Outcome Measures:
  • UV induced skin sensitization [ Time Frame: 4 days ]

Enrollment: 60
Study Start Date: January 2008
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
  More Information

Responsible Party: D. Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00604032     History of Changes
Other Study ID Numbers: 029-066-09-001
First Submitted: January 16, 2008
First Posted: January 29, 2008
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