Bioequivalence Study Comparing Clindamycin Phosphate (1.2%) and Tretinoin (0.025%) Topical Gel to Ziana and Placebo

Summary

ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) gel, marketed by Medicis, The Dermatology Company®, is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of clindamycin phosphate (1.2%) and tretinoin (0.025%) topical gel and the current study is designed to evaluate the bioequivalence of this formulation to ZIANA®.

Conditions

• MILD TO SEVERE ACNE VULGARIS

Interventions

DRUG

CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL

Topical Gel applied in the evening for 84 days

DRUG

ZIANA®

Topical Gel applied in the evening for 84 days

DRUG

Vehicle Control

Topical Gel applied in the evening for 84 days.

Sponsors & Collaborators

• Actavis Mid-Atlantic LLC

  lead INDUSTRY

Principal Investigators

• Madhuri Tadepalli, MD · Skin and Cosmetology Clinic

• Bela J. Shah, MD · BJ Medical College and Civil Hospital

• Abir Saraswat, MD · Indu Shree Clinic

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

• V. R. Sardesai, MD · Sardesai Clinic

• Girish BS, MD · Justice KS Hedge Charitable Hospital

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

• Rajkumar V., MD · Dhanawantari Polyclinic

• Mukta Sachdev, MD · MS Clinical Research Pvt. Ltd

• Anilkumar Malik, MD · G.M Modi Hospital

• Narayana Rao, MD · Skin and Cosmetology

• Guru Prasad, MD · Dayal Clinic

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

• Bhanuja Rani, MD · GVK Clinic

• Mishra RS, MD · Skin Care and Cosmetology Centre

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

• BV Ramachandra, MD · Andhra Medical College

• Akhilesh Agarwal, MD · Twacha Skin and Hair Clinic

• Deepak Kotkar, MD · Dr. Deepak Kotkar Clinic

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

• Jayesh Kothari, MD · Skin Clinic

• MG Gopal, MD · Kempegowda Institute of Medical Sciences

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

• Meethesh Agrawal, MD · Skin Clinic

• 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

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

• Bhavesh K. Swarnakar, MD · Swarnakar's Clinic

• Jayakar Thomas, MD · J.T. Skin Care Centre

• Karigi Siddalingappa, MD · Vijayanagara Institute Of Medical Sciences

• DVS Pratap, MD · Durga Bai Deshmukh Hospital and Research Center

• Amit Madan, MD · Madan's Skin Care Centre

• Rajeev Agarwal, MD · MV Hospital and Research Center

• Ramesh Bhat, MD · Father Muller Medical College and Hospital

• Ravindra B P, MD · Raga's Skin Care

• S. Sacchidananda, MD · CITI Hospital

• Veena Patil, MD · Medi Derma Hospital

• Dinesh V Deshpande, MD · Deshpande Skin Clinic

• Ajay J Deshpande, MD · Dr. Ajay Deshpande's Clinic

• Sudhakar Grandhi, MD · Medipoint Hospitals Pvt. Ltd.

• Anirudh D. Gulanikar, MD · Gulanikar Skin Clinic

• Prashant K Palwade, MD · Keshav Skin and Hair Clinic

• Uday Kulkarni, MD · Skin Care and Cosmetology Clinic

• Amit Luthra, MD · Ishira Skin Clinic

• K Venkatachalam, MD · Sri Gayathri Skin Care and Hair Transplant Centre

• Apoorva Jain, MD · Max Skin Care Centre

• Pradyumna P Vaidya, MD · Clinical Development Centre Pvt. Ltd.

• Prachi A Matte, MD · Derma Lazer Clinic

• Vikrant A Saoji, MD · Dr. Vikrant Saoji Skin Clinic

• Archana M Goyal, MD · Laser and Skin Clinic Jaipur

• Anshu Jain, MD · Skin Clinic

• Vijay Zawar, MD · Skin Clinic

• Sushil Y Pande, MD · Sparsh Hospital and Poly Clinic

• Sujata Sengupta, MD · BP Poddar Hospital and Medical Research Limited

• Kote R Purushottam, MD · Skin Care Clinic

• Kiran Godse, MD · Shree Skin Centre and Pathology Laboratory

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2010-10-31

Completion

2010-10-31

Countries

• India

Study Locations