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To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel

Information source: Cadila Healthcare Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel (Drug); DUAC® Gel (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Cadila Healthcare Limited

Official(s) and/or principal investigator(s):
Dr Charu Gautam, M.D,DNB, Study Director, Affiliation: Cliantha Research Limited

Overall contact:
Dr. Nilendu Sen, Phone: +91-22-25838259, Email: nilendu.sen@zyduscadila.com

Summary

This is an Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study. The main objective is to evaluate bioequivalence of Test formulation (Clindamycin Phosphate 1. 2%/Benzoyl peroxide 5% gel) of Cadila Healthcare with Reference formulation (DUAC Gel of Stiefel Laboratories)in the ratio of 2: 2:1 of Test drug, Reference drug and Placebo respectively. Total study duration will be for a period of 78 days which includes treatment duration of 77 days. 850 subjects will be enrolled (randomized)as per the inclusion and exclusion criteria mentioned in the protocol.

Clinical Details

Official title: A Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel (of Cadila Healthcare Limited, India) Versus DUAC Gel (of Stiefel Laboratories, USA) Versus Placebo (Vehicle Gel) in the Ratio of 2:2:1 Respectively, in Patients With Acne Vulgaris

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions.

Secondary outcome:

Mean percent change from baseline to week 11 in the non-inflammatory lesion count

Proportion of subjects with a clinical response of "success" at week 11

Eligibility

Minimum age: 12 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris 2. On the face, ≥ 25 non-inflammatory lesions (i. e., open and closed comedones) AND ≥ 20 inflammatory lesions (i. e., papules and pustules) AND ≤ 2 nodulocystic lesions (i. e., nodules and cysts). 3. Investigator's Global Assessment (IGA) of acne severity grade 2, 3 OR 4 4. Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period. 5. If female of childbearing potential, willing to use an acceptable form of birth control during the study. 6. Have used the same brand of make-up for a minimum period of 2 weeks prior to randomization, for subjects who use make-up, and agree to not change make-up brands or types during the study. 7. Willing to provide written informed consent or assent (HIPAA consent/authorization, as applicable) Exclusion Criteria: 1. Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e. g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). 2. Patients who have acne conglobata, acne fulminans and secondary acne (e. g.: chloracne and drug induced acne). 3. Excessive facial hair (e. g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well trimmed moustaches are allowed. 4. History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients. 5. Patients who have a severe or intense irritation on the Face. 6. Use within 6 months prior to baseline (Randomization) of oral retinoids (e. g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed). 7. Use for less than 3 months prior to baseline (Randomization) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study. 8. Use on the face within 1 month prior to baseline (Randomization) or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy. 9. Use within 1 month prior to baseline (Randomization) of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents. 10. Use within 2 weeks prior to baseline (Randomization) of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics. 11. Patients who have had general anesthesia for any reason and patients who have received neuromuscular blocking agents within 14 days prior to study entry (Randomization). 12. Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids. 13. Concomitant use of mega-doses of certain vitamins (such as vitamin D and vitamin B12), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital. 14. Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study. 15. Concomitant use of tanning booths or sunbathing. 16. A significant medical history of or are currently immunocompromised 17. Have any systemic or dermatologic disease that may affect the evaluation of study results. 18. Have a history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis. 19. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies. 20. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight. 21. Subjects with History of Alcohol abuse or other drugs of abuse within 2 years prior to Randomization. 22. Female subjects who are breast-feeding or planning to become pregnant. 23. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrollment.

Locations and Contacts

Dr. Nilendu Sen, Phone: +91-22-25838259, Email: nilendu.sen@zyduscadila.com

Ganga Ram Hospital,, Delhi 110 060, India; Active, not recruiting

Gandhi Hospital,, Hyderabad, Andhra Pradesh 500048, India; Active, not recruiting

Osmania General Hospital, Hyderabad, Andhra Pradesh 500012, India; Active, not recruiting

King George Hospital, Vishakhapatnam, Andrapradesh 530002, India; Active, not recruiting

Universal BioPharma Research, Dinuba, California 93618, United States; Recruiting
Dr. David Cardona,, Phone: 559-595-1861
Dr. Cardona David, Principal Investigator

Research Across America, Santa Ana, California 92705, United States; Recruiting
Dr.Vince Afsahi, M.D, Phone: 714-542-3008
Dr.Vince Afsahi, M.D, Principal Investigator

Maulana Azad Medical College, New Delhi, Delhi 110002, India; Active, not recruiting

Visions Clinical Research, Boynton Beach, Florida 33472, United States; Active, not recruiting

Dermatology Research Instititue, Coral Gables, Florida 33146, United States; Active, not recruiting

International Dermatology Research, Inc., Miami, Florida 33144, United States; Active, not recruiting

AMC-MET Medical College, Sheth LG General Hospital,, Ahmedabad, Gujarat 380008, India; Active, not recruiting

Dept of Dermatology, Leprosy and STI, Civil Hospital and BJ Medical College,, Ahmedabad, Gujarat 380016, India; Active, not recruiting

NHL Medical College and VS Hospital, Ahmedabad, Gujarat 380006, India; Active, not recruiting

Sanjeevani Hospital,, Ahmedabad, Gujarat 380015, India; Active, not recruiting

Dept of Dermatology, BYL Nair Hospital and TN medical college, Dr ALNair Road, Mumbai Central,, Mumbai, Gujarat 400 008, India; Not yet recruiting
Dr. Chitra Nayak, Phone: 022 26027641, Email: chitra1202@yahoo.co.in
Dr. Chitra Nayak, Principal Investigator

Department of Dermatology, New Civil Hospital and Government Medical College, Surat, Gujarat 395001, India; Active, not recruiting

Baroda Medical College, Vadodara, Gujarat 390001, India; Active, not recruiting

The Indiana Clinical Trials Center, Plainfield, Indiana 46168, United States; Active, not recruiting

Dept of Dermatology, Bhagawan Mahaveer Jain Hospital Millers Road,Vasanthnagar -, Bangalore, Karnataka 560 052, India; Active, not recruiting

Dept of Dermatology, Kempegowda Institute of Medical Sciences, Bangalore, Karnataka 560004, India; Active, not recruiting

Sapthagiri Hospital,, Bangalore, Karnataka 560073, India; Active, not recruiting

Dept of Skin & STD, JSS Hospital Ramanuja Road, -, Mysore, Karnataka 570004, India; Active, not recruiting

Dermatology Specialists, Louisville, Kentucky 40202, United States; Recruiting
Dr. Joseph Fowler, M.D, Phone: 502-583-7546
Dr.Joseph Fowler, M.D, Principal Investigator

Government Medical Collge, Nagpur, Maharashtra 440003, India; Active, not recruiting

NKP Salve Institute of Medical Siences and Lata Mangeshkar Hospital,, Nagpur, Maharashtra 440019, India; Active, not recruiting

Dr. D Y Patil Hospital and Research Center, Navi Mumbai, Maharashtra 400706, India; Active, not recruiting

Jehangir Clinical Development Center, Pune, Maharashtra 411001, India; Active, not recruiting

Medipoint Hosp, Pune, Maharashtra 411007., India; Active, not recruiting

Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States; Recruiting
Dr.Kempers Steven, M.D, Phone: 763-571-4200
Dr. Steven Kempers, M.D, Principal Investigator

Skin Specialists, PC, Omaha, Nebraska 68144, United States; Recruiting
Dr. Joel Schlessinger, Phone: 402-334-7546
Dr. Joel Schlessinger, Principal Investigator

Academic Dermatology Associates, Albuquerque, New Mexico 87106, United States; Recruiting
Dr.Alicia Bucko, DO,JD, Phone: 505-247-4220
Dr. Alicia Bucko, DO,JD, Principal Investigator

Yardley Dermatology Associates, Yardley, Pennsylvania 19067, United States; Active, not recruiting

Postgraduate Institute of Medical Education & Research (PGIMER), Chandigarh, Punjab 160012, India; Active, not recruiting

Discover Research, Bryan, Texas 77802, United States; Recruiting
Dr. Anna Damian, Phone: 979-731-1212
Dr. Anna Damian, Principal Investigator

M.V. Hospital and research Center, Lucknow, Uttar Pradesh 226003, India; Active, not recruiting

Institute of Post graduate medical and Research, Kolkata, West Bengal 700020, India; Active, not recruiting

Additional Information

1. Feldman S, Careccia RE, Barham KL, et al. Diagnosis and treatment of acne. Am Fam Physician

2. NilFroushzadeh MA, Siadat AH, Baradaran EH, Moradi S. Clindamycin lotion alone versus combination lotion of clindamycin phosphate plus Tretinoin versus combination lotion of clindamycin phosphate plus salicylic acid in the topical treatment of mild to

6. Barza M, Goldstein JA, Kane A. Systemic absorption of clindamycin hydrochloride after topical application. Journal of the American Academy of Dermatology

Cleocin T® Prescribing Information

Guin JD, Lummis WL. Comedonal levels of free clindamycin following topical treatment with a 1% solution of clindamycin phosphate. Journal of the American Academy of Dermatology

Guin JD, Reynolds R, Gielerak PL. Penetration of topical clindamycin into comedones. Journal of the American Academy of Dermatology

Plaisnce KI, Drusano GL, Forrest A, Townsend RJ, Standiford HC. Pharmacokinetic evaluation of two dosage regimens of clindamycin phosphate. Antimicrob Agents Chemother

Brodasky TF, Lewis C, Eble TE. Distribution and metabolism of Antibiotics in the whole animal I. clindamycin in the rat

Nacht S, Yeung D, Beasley JN, Anjo MD, Maibach HI. Benzoyl peroxide: percutaneous penetration and metabolic disposition. Journal of the American Academy of Dermatology

DUAC® Gel Prescribing Information

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Draft Guidance for Industry: Acne Vulgaris: Developing Drugs for Treatment.

Related publications:

Eller MG, Smith RB, Phillips JP. Absorption kinetics of topical clindamycin preparations. Biopharm Drug Dispos. 1989 Sep-Oct;10(5):505-12.

Zouboulis CC, Fischer TC, Wohlrab J, Barnard J, Alió AB. Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris. Cutis. 2009 Oct;84(4):223-9.

Starting date: November 2013
Last updated: December 6, 2013

Page last updated: August 23, 2015

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