A Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Adapalene 0.1% and Benzoyl peroxide 2.5% Gel (Morningside Healthcare Ltd, UK) versus EPIDUO 0.1%/2.5% Gel (Galderma U.K Ltd) in Subjects with Acne Vulgaris.

Morningside Healthcare Ltd0 sites550 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

November 4, 2019

Last Updated

4 years ago

Study Type

Ba/be

Sponsor

•1\. Healthy male or non\-pregnant female aged \>\= 09 and \<\= 40 years with a clinical diagnosis of Acne vulgaris with facial involvement.
•2\. A minimum of 20 but not more than 50 inflammatory lesions (papules and pustules) on the face and not more than two acne nodules.
•3\. A minimum of 30 but not more than 100 non\-inflammatory lesions (open comedones and closed comedones) on the face.
•4 Investigatorâ??s Global Assessment (IGA) of acne severity grade 3 OR 4 (refer
•5\. Willing to refrain from use of all other topical acne medications or antibiotics during the 12 weeks treatment period.
•6\. Male subjects and female of childbearing potential, willing to use an acceptable form of birth control including abstinence, from study start to 30 days after the last application of study medication.
•7\. 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.
•8\. Willingness and ability to comply with the protocol (for subjects under 18 years of age, the parent/LAR must also have been willing and able to comply with study requirements).
•9\. Willing to provide written informed consent or assent (as applicable).

•1\. Females who are breast feeding, pregnant or planning to become pregnant.
•2\. Any acne cyst.
•3\. 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).
•4\. Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g., chloracne and drug induced acne).
•5\. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.), tattoos that would interfere with diagnosis or assessment of acne vulgaris. Well\-trimmed moustaches are allowed.
•6\. Subjects who have performed wax epilation of the face within 14 days prior to baseline.
•7\. History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any of the study medication ingredients
•8\. Subjects who have a severe or intense irritation on the Face.
•9\. Use within 6 months prior to baseline (Randomization) or during the study of oral retinoids (e.g. AccutaneÂ®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
•10\. 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.