Clinical trial NCT02005666: To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
DUAC
CADILA
CLIANTHA
Lead sponsor: Zydus Lifesciences Limited
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 850
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions.
timeFrame: week 11
Secondary outcomes:
measure: Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count
timeFrame: week 11
measure: Proportion of Subjects With a Clinical Response of "Success" at Week 11
timeFrame: Week 11
Other outcomes:
Locations:
city: Dinuba
country: United States
facility: Universal BioPharma Research
state: California
city: Santa Ana
country: United States
facility: Research Across America
state: California
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: Dermatology Research Instititue
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Yardley
country: United States
facility: Yardley Dermatology Associates
state: Pennsylvania
city: Bryan
country: United States
facility: Discover Research
state: Texas
city: Hyderabad
country: India
facility: Osmania General Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Gandhi Hospital,
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andrapradesh
city: New Delhi
country: India
facility: Maulana Azad Medical College
state: Delhi
city: Ahmedabad
country: India
facility: NHL Medical College and VS Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: AMC-MET Medical College, Sheth LG General Hospital,
state: Gujarat
city: Ahmedabad
country: India
facility: Sanjeevani Hospital,
state: Gujarat
city: Ahmedabad
country: India
facility: Dept of Dermatology, Leprosy and STI, Civil Hospital and BJ Medical College,
state: Gujarat
city: Mumbai
country: India
facility: Dept of Dermatology, BYL Nair Hospital and TN medical college, Dr ALNair Road, Mumbai Central,
state: Gujarat
city: Surat
country: India
facility: Department of Dermatology, New Civil Hospital and Government Medical College
state: Gujarat
city: Vadodara
country: India
facility: Baroda Medical College
state: Gujarat
city: Bangalore
country: India
facility: Dept of Dermatology, Bhagawan Mahaveer Jain Hospital Millers Road,Vasanthnagar -
state: Karnataka
city: Bangalore
country: India
facility: Dept of Dermatology, Kempegowda Institute of Medical Sciences
state: Karnataka
city: Bangalore
country: India
facility: Sapthagiri Hospital,
state: Karnataka
city: Mysore
country: India
facility: Dept of Skin & STD, JSS Hospital Ramanuja Road, -
state: Karnataka
city: Nagpur
country: India
facility: Government Medical Collge
state: Maharashtra
city: Nagpur
country: India
facility: NKP Salve Institute of Medical Siences and Lata Mangeshkar Hospital,
state: Maharashtra
city: Navi Mumbai
country: India
facility: Dr. D Y Patil Hospital and Research Center
state: Maharashtra
city: Pune
country: India
facility: Jehangir Clinical Development Center
state: Maharashtra
city: Pune
country: India
facility: Medipoint Hosp
state: Maharashtra
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research (PGIMER)
state: Punjab
city: Lucknow
country: India
facility: M.V. Hospital and research Center
state: Uttar Pradesh
city: Kolkata
country: India
facility: Institute of Post graduate medical and Research
state: West Bengal
city: Delhi
country: India
facility: Ganga Ram Hospital,
Study officials:
affiliation: Cliantha Research Limited
name: Dr Dharmesh Domadia, M.D
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.