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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
  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:


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
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 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
Dermatologic Agents
Keratolytic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014