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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Cadila Healthcare Limited
Sponsor:
Information provided by (Responsible Party):
Cadila Healthcare Limited
ClinicalTrials.gov Identifier:
NCT02005666
First received: November 28, 2013
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel
Drug: DUAC® Gel
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Cadila Healthcare Limited:

Primary Outcome Measures:
  • Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions. [ Time Frame: week 11 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean percent change from baseline to week 11 in the non-inflammatory lesion count [ Time Frame: week 11 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a clinical response of "success" at week 11 [ Time Frame: Week 11 ] [ Designated as safety issue: No ]

Estimated Enrollment: 850
Study Start Date: November 2013
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: 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
Other Name: 1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of CHL
Active Comparator: 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
Drug: DUAC® Gel
Drug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
Other Name: DUAC® Gel (of Stiefel Laboratories
Placebo Comparator: Placebo
Drug:-Placebo (Vehicle Gel) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
Drug: Placebo
Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
Other Name: Placebo (Vehicle Gel)

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005666

Contacts
Contact: Dr. Nilendu Sen +91-22-25838259 nilendu.sen@zyduscadila.com
Contact: Dr Kevinkumar Kansagra, MD +91-2717665555 kevinkumarkansagra@zyduscadila.com

  Show 36 Study Locations
Sponsors and Collaborators
Cadila Healthcare Limited
Investigators
Study Director: Dr Charu Gautam, M.D,DNB Cliantha Research Limited
  More Information

Additional Information:
Publications:
Responsible Party: Cadila Healthcare Limited
ClinicalTrials.gov Identifier: NCT02005666     History of Changes
Other Study ID Numbers: CRL/CT/09/11-12
Study First Received: November 28, 2013
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Keywords provided by Cadila Healthcare Limited:
Acne Vulgaris
DUAC
CADILA
CLIANTHA

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014