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

NACompletedINTERVENTIONAL
Enrollment

885

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Acne Vulgaris
Interventions
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

DRUG

EPIDUO

EPIDUO (adapalene 0.1% and benzoyl peroxide 2.5%) Gel

DRUG

Placebo (Vehicle Gel)

Vehicle Gel

Trial Locations (25)

14623

Skin Search of Rochester Inc., Rochester

27262

Dermatology Consulting Services, High Point

33027

FXM Research Miramar, Miramar

33175

FXM Research Corp., Miami

44118

Haber Dermatology and Cosmetic Surgery Inc., South Euclid

46168

The Indiana Clinical Trials Center, Plainfield

66211

Adult & Pediatric Dermatology, Overland Park

94538

Center for Dermatology Clinical Research Inc., Fremont

500034

Skin & Cosmetology Clinic, Banjara Hills

500044

Department of Dermatology, Durga Bai Deshmukh Hospital, Vidyānagar

530002

B.V. Department of Dermatology King George Hospital, Visakhapatnam

Skin & Cosmetology, Visakhapatnam

530016

Sri Gayathri Skin Care & Hair Transplant Centre, Dwarakanagar

560025

MS Clinical Research Pvt. Ltd., Bangalore

560043

Rajbal Polyclinic & Research Center, Kalyan Nagar

Unknown

FXM Research International - Belize, Belize City

560 061

Raga's Skin Care, Bangalore

560 018

Chamarajpet Skin and Laser Centre, Chamarajpet

560-004

Department of Skin & STD, Kempegowda Institute of Medical Sciences,, V.V. Puram

560-052

Bhagwan Mahaveer Jain Hospital, Vasanthnagar

452 001

Bhatia Skin, Laser & Cosmetic Center, Anand Bazar

Skin Clinic, RNT Marg

452 018

Swarnakar Super Specialty Centre, Anand Bazar

452 010

Agrawal Skin & Laser Centre, Vijayanagar

530 016

Dayal Clinic, Visakhapatnam

All Listed Sponsors
lead

Actavis Mid-Atlantic LLC

INDUSTRY

NCT01501799 - 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 | Biotech Hunter | Biotech Hunter