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 DUACÂ® Gel (of Stiefel Laboratories, USA) versus Placebo (Vehicle Gel) in the ratio of 2:2:1 respectively, in Patients with Acne Vulgaris.

Cadila Healthcare Limited0 sites850 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•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\. Investigatorâ??s Global Assessment (IGA) of acne severity grade 2,3 OR 4 (per Table 1\)
•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).

•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.
•AccutaneÂ®) 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.

Not specified