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

This study has been completed.
Sponsor:
Information provided by:
Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:
NCT00604032
First received: January 16, 2008
Last updated: March 26, 2008
Last verified: February 2008
History of Changes
  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 Blind (Outcomes Assessor)
Official Title: Clinical Evaluation of the Phototoxic Potential of Atralin (Tretinoin) Gel, 0.05%

Resource links provided by NLM:

Drug Information available for: Tretinoin
U.S. FDA Resources

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

Primary Outcome Measures:
  • UV induced skin sensitization [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: D. Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00604032     History of Changes
Other Study ID Numbers: 029-066-09-001
Study First Received: January 16, 2008
Last Updated: March 26, 2008
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Coria Laboratories, Ltd.:
Safety when exposed to sunlight

Additional relevant MeSH terms:
Tretinoin
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013