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

NCT01257906 | Completed

• 1 other identifier: Acta/Clin-Tret/2009
• Study Type: interventional
• Target: 1,225
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

acne; Ziana; clindamycin; tretinoin

Outcome Measures

Primary Outcomes (3)

• Therapeutic Equivalence

  The primary equivalence comparison is that between the test and reference products for the mean percent change from baseline in the inflammatory lesion counts and the non-inflammatory lesion counts at Visit 5.

  12-weeks

• Superiority

  The primary superiority evaluations are the comparisons between each active treatment and the vehicle control relative to the mean percent change in the inflammatory lesion counts and the non-inflammatory lesion counts.

  12-Weeks

• Safety

  All treatment-emergent adverse events reported during the study will be summarized in order to assess safety.

  12-Weeks

Study Arms (3)

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

EXPERIMENTAL

Topical Gel Test Product

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

ZIANA®

ACTIVE COMPARATOR

Topical Gel Reference Product

Drug: ZIANA®

Vehicle Control

PLACEBO COMPARATOR

Topical Gel Placebo

Drug: Vehicle Control

Interventions

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

Topical Gel applied in the evening for 84 days

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

ZIANA® DRUG

Topical Gel applied in the evening for 84 days

ZIANA®

Vehicle Control DRUG

Topical Gel applied in the evening for 84 days.

Vehicle Control

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. Male or nonpregnant female patients must be between the ages of 12 and 40 years old inclusive. 2. Patients who are 18 years of age or older must have provided IRB/IEC approved written informed consent. Patients between the ages of 12 to 17 years of age must have provided IRB/IEC approved written assent; this written assent must be accompanied by an IRB/IEC approved written informed consent from the patient's legally acceptable representative (i.e., parent or guardian). In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization, if applicable. 3. Patients must have a definite clinical diagnosis of mild to severe acne vulgaris (Grade 2, Grade 3 or Grade 4 on the IGE). 4. Patients must have a minimum of 20 and a maximum of 100 facial inflammatory lesions at baseline. Patients must also have a minimum of 25 and a maximum of 100 non-inflammatory lesions (i.e., open and closed comedones) at baseline. Patients may have no more than two (2) nodulo-cystic lesions at baseline. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Lesions involving the eyes, angles of the nose (i.e., the lines around your nostrils and under the nostrils) and scalp should be excluded from the count. Patients may have acne lesions on other areas of the body (e.g., on the back). 5.Female patients of childbearing potential must have been using accepted methods of birth control or must agree to continue to practice abstinence, from 30 days prior to study entry to 30 days after the last administration of study drug. All female patients are considered to be of childbearing potential unless they have been surgically sterilized or have been postmenopausal for at least 1 year. Abstinence is an acceptable method of birth control. Alternatively, any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®) Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD. Female patients must have a negative urine pregnancy test at baseline. A negative result of a pregnancy test having a minimum sensitivity of at least 50 mIU/ml for hCG should be obtained. 6. All male patients must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 30 days after the last administration of study drug. Abstinence is an acceptable method of birth control. Alternatively, any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD. 7. Patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. 8. Patients must be willing to refrain from using any treatments for acne vulgaris, including antibiotics, other than the investigational product, for acne present on the face. Patients may use other topical acne treatments that do not have significant or measurable systemic absorption for treatment of acne of the back, shoulders and chest (e.g., benzoyl peroxide, salicylic acid). 9. Patients must be in good health and free from any clinically significant disease. 10. Patients who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.

Sponsors & Collaborators

• Actavis Mid-Atlantic LLC: lead

Study Sites (1)

Lotus Labs Pvt. Ltd

Bangalore, 560 034, India

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Tretinoin; Gels; clindamycin, tretinoin drug combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Madhuri Tadepalli, MD

  Skin and Cosmetology Clinic

  PRINCIPAL INVESTIGATOR

• Bela J. Shah, MD

  BJ Medical College and Civil Hospital

  PRINCIPAL INVESTIGATOR

• Abir Saraswat, MD

  Indu Shree Clinic

  PRINCIPAL INVESTIGATOR

• Manoj K. Parekh, MD

  Bhagwan Mahaveer Jain Hospital

  PRINCIPAL INVESTIGATOR

• V. R. Sardesai, MD

  Sardesai Clinic

  PRINCIPAL INVESTIGATOR

• Girish BS, MD

  Justice KS Hedge Charitable Hospital

  PRINCIPAL INVESTIGATOR

• Leelavathy B., MD

  Bowring & Lady Curzon Hospital

  PRINCIPAL INVESTIGATOR

• Rajkumar V., MD

  Dhanawantari Polyclinic

  PRINCIPAL INVESTIGATOR

• Mukta Sachdev, MD

  MS Clinical Research Pvt. Ltd

  PRINCIPAL INVESTIGATOR

• Anilkumar Malik, MD

  G.M Modi Hospital

  PRINCIPAL INVESTIGATOR

• Narayana Rao, MD

  Skin and Cosmetology

  PRINCIPAL INVESTIGATOR

• Guru Prasad, MD

  Dayal Clinic

  PRINCIPAL INVESTIGATOR

• Jayadev Betkerur, MD

  J.S.S. Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Bhanuja Rani, MD

  GVK Clinic

  PRINCIPAL INVESTIGATOR

• Mishra RS, MD

  Skin Care and Cosmetology Centre

  PRINCIPAL INVESTIGATOR

• Hemanji R. Jerajani, MD

  L.T.M. Medical College & General Hospital

  PRINCIPAL INVESTIGATOR

• BV Ramachandra, MD

  Andhra Medical College

  PRINCIPAL INVESTIGATOR

• Akhilesh Agarwal, MD

  Twacha Skin and Hair Clinic

  PRINCIPAL INVESTIGATOR

• Deepak Kotkar, MD

  Dr. Deepak Kotkar Clinic

  PRINCIPAL INVESTIGATOR

• Alur S. Kumar, MD

  Owaisi Hospital & Research Centre

  PRINCIPAL INVESTIGATOR

• Jayesh Kothari, MD

  Skin Clinic

  PRINCIPAL INVESTIGATOR

• MG Gopal, MD

  Kempegowda Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• D. N. Balraj, MD

  Rajbal Skin Clinic

  PRINCIPAL INVESTIGATOR

• Meethesh Agrawal, MD

  Skin Clinic

  PRINCIPAL INVESTIGATOR

• Ravi M. Rathod, MD

  Skin Care Centre

  PRINCIPAL INVESTIGATOR

• Ranjan C. Raval, MD

  Smt. NHL Medical College and V.S. Hospital

  PRINCIPAL INVESTIGATOR

• V. K. Somani, MD

  Somani Skin and Cosmetology Institute

  PRINCIPAL INVESTIGATOR

• Kailash Bhatia, MD

  Bhatia Skin, Laser, & Cosmetic Center

  PRINCIPAL INVESTIGATOR

• Bhavesh K. Swarnakar, MD

  Swarnakar's Clinic

  PRINCIPAL INVESTIGATOR

• Jayakar Thomas, MD

  J.T. Skin Care Centre

  PRINCIPAL INVESTIGATOR

• Karigi Siddalingappa, MD

  Vijayanagara Institute Of Medical Sciences

  PRINCIPAL INVESTIGATOR

• DVS Pratap, MD

  Durga Bai Deshmukh Hospital and Research Center

  PRINCIPAL INVESTIGATOR

• Amit Madan, MD

  Madan's Skin Care Centre

  PRINCIPAL INVESTIGATOR

• Rajeev Agarwal, MD

  MV Hospital and Research Center

  PRINCIPAL INVESTIGATOR

• Ramesh Bhat, MD

  Father Muller Medical College and Hospital

  PRINCIPAL INVESTIGATOR

• Ravindra B P, MD

  Raga's Skin Care

  PRINCIPAL INVESTIGATOR

• S. Sacchidananda, MD

  CITI Hospital

  PRINCIPAL INVESTIGATOR

• Veena Patil, MD

  Medi Derma Hospital

  PRINCIPAL INVESTIGATOR

• Dinesh V Deshpande, MD

  Deshpande Skin Clinic

  PRINCIPAL INVESTIGATOR

• Ajay J Deshpande, MD

  Dr. Ajay Deshpande's Clinic

  PRINCIPAL INVESTIGATOR

• Sudhakar Grandhi, MD

  Medipoint Hospitals Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

• Anirudh D. Gulanikar, MD

  Gulanikar Skin Clinic

  PRINCIPAL INVESTIGATOR

• Prashant K Palwade, MD

  Keshav Skin and Hair Clinic

  PRINCIPAL INVESTIGATOR

• Uday Kulkarni, MD

  Skin Care and Cosmetology Clinic

  PRINCIPAL INVESTIGATOR

• Amit Luthra, MD

  Ishira Skin Clinic

  PRINCIPAL INVESTIGATOR

• K Venkatachalam, MD

  Sri Gayathri Skin Care and Hair Transplant Centre

  PRINCIPAL INVESTIGATOR

• Apoorva Jain, MD

  Max Skin Care Centre

  PRINCIPAL INVESTIGATOR

• Pradyumna P Vaidya, MD

  Clinical Development Centre Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

• Prachi A Matte, MD

  Derma Lazer Clinic

  PRINCIPAL INVESTIGATOR

• Vikrant A Saoji, MD

  Dr. Vikrant Saoji Skin Clinic

  PRINCIPAL INVESTIGATOR

• Archana M Goyal, MD

  Laser and Skin Clinic Jaipur

  PRINCIPAL INVESTIGATOR

• Anshu Jain, MD

  Skin Clinic

  PRINCIPAL INVESTIGATOR

• Vijay Zawar, MD

  Skin Clinic

  PRINCIPAL INVESTIGATOR

• Sushil Y Pande, MD

  Sparsh Hospital and Poly Clinic

  PRINCIPAL INVESTIGATOR

• Sujata Sengupta, MD

  BP Poddar Hospital and Medical Research Limited

  PRINCIPAL INVESTIGATOR

• Kote R Purushottam, MD

  Skin Care Clinic

  PRINCIPAL INVESTIGATOR

• Kiran Godse, MD

  Shree Skin Centre and Pathology Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 10, 2010

Record last verified: 2010-12

Locations

IN (1)