Clinical Evaluation of the Photoallergy Potential of Atralin Gel - Tabular View

Tracking Information

First Received Date ^ICMJE

January 8, 2008

Last Updated Date

May 5, 2008

Start Date ^ICMJE

January 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

UV Induced skin irritation [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00603772 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Atralin (tretinoin) gel, 0.05%

Study Arms / Comparison Groups

Experimental: Safety when exposed to sunlight

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2008

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00603772

Responsible Party

D. Innes Cargill, PhD, Coria Laboratories, Ltd.

Study ID Numbers ^ICMJE

029-066-09-002

Study Sponsor ^ICMJE

Coria Laboratories, Ltd.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Joseph W Stanfield, MS

Suncare Research Laboratories

Information Provided By

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