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

January 8, 2008
May 5, 2008
January 2008
March 2008   (final data collection date for primary outcome measure)
UV Induced skin irritation [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00603772 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Evaluation of the Photoallergy Potential of Atralin Gel
Clinical Evaluation of the Photoallergy Potential of Atralin Gel (Tretinoin Gel 0.05%)

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Healthy
Drug: Atralin (tretinoin) gel, 0.05%
Assess photoallergic reactions for tretinoin 0.05% and vehicle, measured as skin reactions following induction and challenge.
Experimental: 1
Safety when exposed to sunlight
Intervention: Drug: Atralin (tretinoin) gel, 0.05%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Less than 18 years of age
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00603772
029-066-09-002
No
D. Innes Cargill, PhD, Coria Laboratories, Ltd.
Coria Laboratories, Ltd.
Not Provided
Principal Investigator: Joseph W Stanfield, MS Suncare Research Laboratories
Coria Laboratories, Ltd.
February 2008

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