A Study to Evaluate the Irritation Potential of Tazarotene Foam on Skin in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT01112787|
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Tazarotene Foam Drug: Vehicle Foam Drug: Sodium Laural Sulfate Drug: Distilled Water||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase 1, Evaluator-Blinded, Randomized, Vehicle Controlled, Study To Evaluate The Cumulative Irritation Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers|
|Actual Study Start Date :||March 26, 2010|
|Actual Primary Completion Date :||April 26, 2010|
|Actual Study Completion Date :||April 26, 2010|
Experimental: Tazarotene Foam
Subjects will be exposed to patches containing Tazarotene Foam 0.1%,
Drug: Tazarotene Foam
Placebo Comparator: Vehicle Foam
Subjects will be exposed to patches containing Vehicle Foam.
Drug: Vehicle Foam
Active Comparator: Sodium Laural Sulfate
Subjects will be exposed to patches containing Sodium Laural Sulfate.
Drug: Sodium Laural Sulfate
Sodium Laural Sulfate
Placebo Comparator: Distilled Water
Subjects will be exposed to patches containing Distilled Water.
Drug: Distilled Water
- Inflammatory skin responses [ Time Frame: 21 days ]Patch sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.
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): NCT01112787
|United States, Arizona|
|HillTop Research Corporation|
|Scottsdale, Arizona, United States, 85251|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|