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



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - 40
Updated:2/3/2018
Start Date:November 2013
End Date:September 28, 2016

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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

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.


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.
We found this trial at
13
sites
Coral Gables, Florida 33146
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Coral Gables, FL
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Albuquerque, New Mexico 87106
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Albuquerque, NM
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Boynton Beach, Florida 33472
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Boynton Beach, FL
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400 Discovery Drive
Bryan, Texas 77802
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Bryan, TX
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Dinuba, California 93618
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Dinuba, CA
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Fridley, Minnesota 55432
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Fridley, MN
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Hyderabad, Andhra Pradesh 50001
Principal Investigator: Dr. Putta Srinivas
Phone: 040 2460 0146
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Hyderabad,
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Louisville, Kentucky 40202
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Louisville, KY
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Miami, FL
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Omaha, Nebraska 68144
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Omaha, NE
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Plainfield, Indiana 46168
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Plainfield, IN
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Santa Ana, California 92705
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Santa Ana, CA
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Yardley, Pennsylvania 19067
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Yardley, PA
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