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

NCT02005666 | Completed Phase 3 Results DMC

• 1 other identifier: CRL/CT/09/11-12
• Study Type: interventional
• Target: 850
• Locations: 2 countries
• Sites: 36

Brief 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.

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris; DUAC; CADILA; CLIANTHA

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions.

  Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions in PP populations. The primary endpoint of the study is mean percent change from baseline to week 11 (study Day 77) in the inflammatory (papules and pustules) lesion count. Papule was Inflammatory lesion; small (\< 5mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule was Inflammatory lesion; small (\< 5mm in diameter), inflamed skin swelling that is filled with pus. The test product was judged therapeutically equivalent to the reference product in the reduction of inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)

  week 11

Secondary Outcomes (2)

• Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count

  week 11

• Proportion of Subjects With a Clinical Response of "Success" at Week 11

  Week 11

Study Arms (3)

Test-Cadila healthcare limited

EXPERIMENTAL

Drug:-Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days

Drug: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel

Reference

ACTIVE COMPARATOR

Drug:-DUAC® Gel (of Stiefel Laboratories, USA) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days

Drug: DUAC® Gel

Placebo

PLACEBO COMPARATOR

Drug:-Placebo (Vehicle Gel) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days

Drug: Placebo

Interventions

Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel DRUG

Drug:-1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days

Also known as: 1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of CHL

Test-Cadila healthcare limited

DUAC® Gel DRUG

Drug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days

Also known as: DUAC® Gel (of Stiefel Laboratories

Reference

Placebo DRUG

Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days

Also known as: Placebo (Vehicle Gel)

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris
• 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).
• Investigator's Global Assessment (IGA) of acne severity grade 2, 3 OR 4
• Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period.
• If female of childbearing potential, willing to use an acceptable form of birth control during the study.
• 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.
• Willing to provide written informed consent or assent (HIPAA consent/authorization, as applicable)

You may not qualify if:

• 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).
• Patients who have acne conglobata, acne fulminans and secondary acne (e.g.: chloracne and drug induced acne).
• Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well trimmed moustaches are allowed.
• History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients.
• Patients who have a severe or intense irritation on the Face.
• 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).
• 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.
• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
• Concomitant use of tanning booths or sunbathing.

Sponsors & Collaborators

• Zydus Lifesciences Limited: lead

Study Sites (36)

Universal BioPharma Research

Dinuba, California, 93618, United States

Location

Research Across America

Santa Ana, California, 92705, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Dermatology Research Instititue

Coral Gables, Florida, 33146, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Dermatology Specialists

Louisville, Kentucky, 40202, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Yardley Dermatology Associates

Yardley, Pennsylvania, 19067, United States

Location

Discover Research

Bryan, Texas, 77802, United States

Location

Osmania General Hospital

Hyderabad, Andhra Pradesh, 500012, India

Location

Gandhi Hospital,

Hyderabad, Andhra Pradesh, 500048, India

Location

King George Hospital

Visakhapatnam, Andrapradesh, 530002, India

Location

NHL Medical College and VS Hospital

Ahmedabad, Gujarat, 380006, India

Location

AMC-MET Medical College, Sheth LG General Hospital,

Ahmedabad, Gujarat, 380008, India

Location

Sanjeevani Hospital,

Ahmedabad, Gujarat, 380015, India

Location

Dept of Dermatology, Leprosy and STI, Civil Hospital and BJ Medical College,

Ahmedabad, Gujarat, 380016, India

Location

Dept of Dermatology, BYL Nair Hospital and TN medical college, Dr ALNair Road, Mumbai Central,

Mumbai, Gujarat, 400 008, India

Location

Department of Dermatology, New Civil Hospital and Government Medical College

Surat, Gujarat, 395001, India

Location

Baroda Medical College

Vadodara, Gujarat, 390001, India

Location

Dept of Dermatology, Bhagawan Mahaveer Jain Hospital Millers Road,Vasanthnagar -

Bangalore, Karnataka, 560 052, India

Location

Dept of Dermatology, Kempegowda Institute of Medical Sciences

Bangalore, Karnataka, 560004, India

Location

Sapthagiri Hospital,

Bangalore, Karnataka, 560073, India

Location

Dept of Skin & STD, JSS Hospital Ramanuja Road, -

Mysore, Karnataka, 570004, India

Location

Government Medical Collge

Nagpur, Maharashtra, 440003, India

Location

NKP Salve Institute of Medical Siences and Lata Mangeshkar Hospital,

Nagpur, Maharashtra, 440019, India

Location

Dr. D Y Patil Hospital and Research Center

Navi Mumbai, Maharashtra, 400706, India

Location

Jehangir Clinical Development Center

Pune, Maharashtra, 411001, India

Location

Medipoint Hosp

Pune, Maharashtra, 411007., India

Location

Maulana Azad Medical College

New Delhi, National Capital Territory of Delhi, 110002, India

Location

Postgraduate Institute of Medical Education & Research (PGIMER)

Chandigarh, Punjab, 160012, India

Location

M.V. Hospital and research Center

Lucknow, Uttar Pradesh, 226003, India

Location

Institute of Post graduate medical and Research

Kolkata, West Bengal, 700020, India

Location

Ganga Ram Hospital,

Delhi, 110 060, India

Location

Related Publications (2)

• Eller MG, Smith RB, Phillips JP. Absorption kinetics of topical clindamycin preparations. Biopharm Drug Dispos. 1989 Sep-Oct;10(5):505-12. doi: 10.1002/bdd.2510100508.

  PMID: 2804254 BACKGROUND

• Zouboulis CC, Fischer TC, Wohlrab J, Barnard J, Alio 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.

  PMID: 19911678 BACKGROUND

Related Links

• 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
• Cleocin T® Prescribing Information
• Plaisnce KI, Drusano GL, Forrest A, Townsend RJ, Standiford HC. Pharmacokinetic evaluation of two dosage regimens of clindamycin phosphate. Antimicrob Agents Chemother
• 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.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate; Benzoyl Peroxide; Gels

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Mr Anuj K Saini
• Organization: Cadila Healthcare Limited

Anuj.Saini@zyduscadila.com

02717623666

Study Officials

• Dr Dharmesh Domadia, M.D

  Cliantha Research Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 9, 2013
• Study Start: November 1, 2013
• Primary Completion: September 28, 2016
• Study Completion: September 28, 2016
• Last Updated: October 14, 2020
• Results First Posted: September 14, 2020

Record last verified: 2017-02

Locations

US (12); IN (24)