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

NCT ID: NCT02005666

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 850 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-09-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test-Cadila healthcare limited

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

Group Type: EXPERIMENTAL

Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel

Intervention Type: 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

Reference

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

Group Type: ACTIVE_COMPARATOR

DUAC® Gel

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel

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

Intervention Type: DRUG

DUAC® Gel

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of CHL; DUAC® Gel (of Stiefel Laboratories; Placebo (Vehicle Gel)

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zydus Lifesciences Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Dharmesh Domadia, M.D

Role: STUDY_DIRECTOR

Cliantha Research Limited

Locations

Universal BioPharma Research

Dinuba, California, United States

Research Across America

Santa Ana, California, United States

Visions Clinical Research

Boynton Beach, Florida, United States

Dermatology Research Instititue

Coral Gables, Florida, United States

International Dermatology Research, Inc.

Miami, Florida, United States

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Dermatology Specialists

Louisville, Kentucky, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Skin Specialists, PC

Omaha, Nebraska, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Yardley Dermatology Associates

Yardley, Pennsylvania, United States

Discover Research

Bryan, Texas, United States

Osmania General Hospital

Hyderabad, Andhra Pradesh, India

Gandhi Hospital,

Hyderabad, Andhra Pradesh, India

King George Hospital

Visakhapatnam, Andrapradesh, India

NHL Medical College and VS Hospital

Ahmedabad, Gujarat, India

AMC-MET Medical College, Sheth LG General Hospital,

Ahmedabad, Gujarat, India

Sanjeevani Hospital,

Ahmedabad, Gujarat, India

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

Ahmedabad, Gujarat, India

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

Mumbai, Gujarat, India

Department of Dermatology, New Civil Hospital and Government Medical College

Surat, Gujarat, India

Baroda Medical College

Vadodara, Gujarat, India

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

Bangalore, Karnataka, India

Dept of Dermatology, Kempegowda Institute of Medical Sciences

Bangalore, Karnataka, India

Sapthagiri Hospital,

Bangalore, Karnataka, India

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

Mysore, Karnataka, India

Government Medical Collge

Nagpur, Maharashtra, India

NKP Salve Institute of Medical Siences and Lata Mangeshkar Hospital,

Nagpur, Maharashtra, India

Dr. D Y Patil Hospital and Research Center

Navi Mumbai, Maharashtra, India

Jehangir Clinical Development Center

Pune, Maharashtra, India

Medipoint Hosp

Pune, Maharashtra, India

Maulana Azad Medical College

New Delhi, National Capital Territory of Delhi, India

Postgraduate Institute of Medical Education & Research (PGIMER)

Chandigarh, Punjab, India

M.V. Hospital and research Center

Lucknow, Uttar Pradesh, India

Institute of Post graduate medical and Research

Kolkata, West Bengal, India

Ganga Ram Hospital,

Delhi, , India

Countries

United States; India

References

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.

Reference Type: BACKGROUND

PMID: 2804254 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19911678 (View on PubMed)

Related Links

http://www.aafp.org/afp/2004/0501/p2123.html

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

http://www.bioline.org.br/pdf?dv09082

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

http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=16509

Cleocin T® Prescribing Information

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC172501

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

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050741s019lbl.pdf

DUAC® Gel Prescribing Information

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071292.pdf

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.

Other Identifiers

CRL/CT/09/11-12

Identifier Type: -

Identifier Source: org_study_id