Study Comparing 0.3% Adapalene Topical Gel to Differin® 0.3% Adapalene Topical Gel

Summary

Marketed by Galderma Laboratories, L.P., Differin® (adapalene 0.3% topical gel) is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of adapalene 0.3% topical gel and the current study is designed to evaluate the safety and efficacy of this formulation.

Conditions

• Acne Vulgaris

Interventions

DRUG

adapalene 0.3% topical gel

once a day, 84 days

Sponsors & Collaborators

• Actavis Mid-Atlantic LLC

  lead INDUSTRY

Principal Investigators

• Vishal B., MD · Yenepoya Medical College

• Bela J. Shah, MD · GMC and SSG Hospital

• Mhaske, MD · B. J. Medical College and Hospital

• Manoj K. Parekh, MD · Bhagwan Mahaveer Jain Hospital

• V. R. Sardesai, MD · Bharati Vidyapeeth University Medical College & Hospital

• Kailash Bhatia, MD · Bhatia Skin Laser & Cosmetic Centre

• Leelavathy B., MD · Bowring & Lady Curzon Hospital

• Rajkumar V., MD · Dhanawantari Polyclinic

• Mukta Sachdev, MD · Dr. Mukta Skin Clinic

• Anilkumar Malik, MD · G.M Modi Hospital

• Yogesh Marfatia, MD · GMC and SSG Hospital

• Mahendra M. Kura, MD · Grant Medical College & Sir JJ Group of Hospitals

• Jayadev Betkerur, MD · J.S.S. Medical College Hospital

• Manjunath S. M., MD · Justice K.S. Hegde Charitable Hospital

• Ramesh M., MD · Kempegowda Institute of Medical Sciences

• Hemanji R. Jerajani, MD · L.T.M. Medical College & General Hospital

• Vijaykumar Garg, MD · Maulana Azad Medical College Hospital

• Rajitha K., MD · Medwin Hospital

• Putta Srinivas, MD · Osmania General Hospital

• Alur S. Kumar, MD · Owaisi Hospital & Research Centre

• Jayesh Kothari, MD · Skin Clinic

• P. V. S. Prasad, MD · Rajah Muthiah Medical College Hospital

• D. N. Balraj, PI · Rajbal Skin Clinic

• Sailaja K. Surapaneni, MD · SRI Medical Aesthetic and Cosmetic Surgery

• Ravi M. Rathod, MD · Skin Care Centre

• Ranjan C. Raval, MD · Smt. NHL Medical College and V.S. Hospital

• V. K. Somani, MD · Somani Skin and Cosmetology Institute

• Rachita Dhurat, MD · T. N. Medical College and BYL Nair hospital

• P. V. Patalay, MD · Vani Skin Clinic

• Nataraja, MD · Victoria Hospital

• Karigi Siddalingappa, MD · Vijayanagara Institute Of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2009-12-31

Completion

2009-12-31

Countries

• India

Study Locations