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Clinical Evaluation of the Photoallergy Potential of Atralin Gel

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00603772
First Posted: January 29, 2008
Last Update Posted: May 6, 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 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 (Outcomes Assessor)
Official Title: Clinical Evaluation of the Photoallergy Potential of Atralin Gel (Tretinoin Gel 0.05%)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • UV Induced skin irritation [ Time Frame: 4 days ]

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

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 and 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): 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

Responsible Party: D. Innes Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00603772     History of Changes
Other Study ID Numbers: 029-066-09-002
First Submitted: January 8, 2008
First Posted: January 29, 2008
Last Update Posted: May 6, 2008
Last Verified: February 2008

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

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