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Clinical Evaluation of the Photoallergy Potential of Atralin Gel

This study has been completed.
Sponsor:
Information provided by:
Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:
NCT00603772
First received: January 8, 2008
Last updated: May 5, 2008
Last verified: February 2008
History of Changes
  Purpose

To assess the potential of tretinoin gel 0.05% and its vehicle to produce photoallergic reactions, measured as skin reactions following induction and challenge.


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 Photoallergy Potential of Atralin Gel (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 irritation [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Safety when exposed to sunlight
 Drug: Atralin (tretinoin) gel, 0.05%
Assess photoallergic reactions for tretinoin 0.05% and vehicle, measured as skin reactions following induction and challenge.

  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 and older

Exclusion Criteria:

  • Less than 18 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603772

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 W Stanfield, MS Suncare Research Laboratories
  More Information

No publications provided

Responsible Party: D. Innes Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00603772     History of Changes
Other Study ID Numbers: 029-066-09-002
Study First Received: January 8, 2008
Last Updated: May 5, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Coria Laboratories, Ltd.:
Tretinoin
exposure to UV light
phototoxicity
Safety when exposed to sunlight

Additional relevant MeSH terms:
Dermatitis, Photoallergic
Dermatitis, Allergic Contact
Dermatitis, Contact
Dermatitis
Skin Diseases
Photosensitivity Disorders
Skin Diseases, Eczematous
Hypersensitivity, Delayed
 Hypersensitivity
Immune System Diseases
Tretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on June 17, 2013