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

This study has been completed.
Information provided by:
Coria Laboratories, Ltd. Identifier:
First received: January 16, 2008
Last updated: March 26, 2008
Last verified: February 2008
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
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:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Normal healthy volunteers
  • 18 years of age or older

Exclusion Criteria:

  • Less than 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00604032

United States, North Carolina
Suncare Research Laboratories
Winston-Salem, North Carolina, United States, 27106
Sponsors and Collaborators
Coria Laboratories, Ltd.
Principal Investigator: Joseph Stanfiled, MS Suncare Laboratories
  More Information

Responsible Party: D. Cargill, PhD, Coria Laboratories, Ltd. Identifier: NCT00604032     History of Changes
Other Study ID Numbers: 029-066-09-001
Study First Received: January 16, 2008
Last Updated: March 26, 2008

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

Additional relevant MeSH terms:
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents processed this record on May 24, 2017