Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
|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: NCT01209949|
Recruitment Status : Completed
First Posted : September 27, 2010
Results First Posted : January 19, 2012
Last Update Posted : January 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris|
|Study Start Date :||October 2010|
|Primary Completion Date :||January 2011|
|Study Completion Date :||January 2011|
|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel||
Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Apply adapalene BPO gel once daily in the evening for 12 weeks
Other Name: Epiduo® Gel
- Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12 [ Time Frame: 12 weeks ]Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.
- Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. [ Time Frame: Week 12 ]Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.
- Number of Participants With Tolerability Assessments Resulting in an Adverse Event [ Time Frame: 12 weeks ]Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.
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): NCT01209949
|United States, Texas|
|Thomas J. Stephens and Associates|
|Carrollton, Texas, United States, 75006|
|Study Director:||Ronald W Gottschalk, MD||Galderma Laboratories, L.P.|