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Clinical Evaluation of the Photoallergy Potential of Atralin Gel

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.
 
ClinicalTrials.gov Identifier: NCT00603772
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : May 6, 2008
Sponsor:
Information provided by:
Coria Laboratories, Ltd.

Tracking Information
First Submitted Date  ICMJE January 8, 2008
First Posted Date  ICMJE January 29, 2008
Last Update Posted Date May 6, 2008
Study Start Date  ICMJE January 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2008)		 UV Induced skin irritation [ Time Frame: 4 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of the Photoallergy Potential of Atralin Gel
Official Title  ICMJE Clinical Evaluation of the Photoallergy Potential of Atralin Gel (Tretinoin Gel 0.05%)
Brief Summary To assess the potential of tretinoin gel 0.05% and its vehicle to produce photoallergic reactions, measured as skin reactions following induction and challenge.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Atralin (tretinoin) gel, 0.05%
Assess photoallergic reactions for tretinoin 0.05% and vehicle, measured as skin reactions following induction and challenge.
Study Arms  ICMJE Experimental: 1
Safety when exposed to sunlight
Intervention: Drug: Atralin (tretinoin) gel, 0.05%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 16, 2008)		 40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Normal, healthy volunteers
  • 18 years of age and older

Exclusion Criteria:

  • Less than 18 years of age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00603772
Other Study ID Numbers  ICMJE 029-066-09-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party D. Innes Cargill, PhD, Coria Laboratories, Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Coria Laboratories, Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph W Stanfield, MS Suncare Research Laboratories
PRS Account Coria Laboratories, Ltd.
Verification Date February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP