A Bioequivalence Study With Clinical Endpoints Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) in the Treatment of Mild to Severe 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: NCT01501799|
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : December 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: adapalene 0.1% and benzoyl peroxide 2.5% topical gel Drug: EPIDUO Drug: Placebo (Vehicle Gel)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||885 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) and Both Active Treatments to Topical Gel Placebo (Actavis Mid-Atlantic Llc) in the Treatment of Mild to Severe Acne Vulgaris|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
|Experimental: Adapalene 0.1% and benzoyl peroxide 2.5% topical gel||
Drug: adapalene 0.1% and benzoyl peroxide 2.5% topical gel
Dosage form: topical gel Dosage: A pea-sized amount was applied to each affected area of the face Frequency: once daily in the evening Duration: 12 weeks
|Active Comparator: EPIDUO™ (adapalene 0.1% and benzoyl peroxide 2.5%) Gel||
EPIDUO (adapalene 0.1% and benzoyl peroxide 2.5%) Gel
|Placebo Comparator: Vehicle Gel||
Drug: Placebo (Vehicle Gel)
- Percent change in inflammatory and non-inflammatory lesions from Baseline to Week 12 [ Time Frame: Week 12 ]The mean percent change from Baseline to Visit 5 (End of Treatment) in the inflammatory and non-inflammatory lesion counts.
- Treatment-emergent adverse events [ Time Frame: 12 Weeks ]All adverse events (AEs) and treatment-emergent AEs reported during the study were summarized for the safety assessment. A treatment-emergent AE was defined as any event not present prior to the initiation of treatment with the investigational products or any event present at Baseline that worsened in either intensity or frequency following exposure to investigational products.
- Signs and Symptoms of Local Irritation [ Time Frame: 12 Weeks ]
Patients will be evaluated for any signs and/or symptoms as separate scores of local irritation, including: erythema, dryness, burning / stinging, erosion, edema, pain, scaling, and itching using the following scale:
0 = None
- = Mild, barely perceptible
- = Moderate, distinctive presence
- = Severe, marked/intense
- The proportion of "success" patients at Visit 5 using the IGE [ Time Frame: 12 Weeks ]The proportion of "success" patients at Visit 5 using the IGE, where "success" was defined as a two-grade improvement.
- Mean Percent Change in Total Lesion Count from Baseline to Visit 5 [ Time Frame: 12 Weeks ]The mean percent change in the total lesion count from Baseline to Visit 5.
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): NCT01501799
|Study Director:||Nagashayana G., M.D.||Lotus Labs Pvt Ltd|
|Study Director:||Nermina Nakas, M.D., M.P.H.||Jubilant Clinsys, Inc|