A randomized, double blind, controlled, multicentric, Phase III, parallel group evaluation of safety and efficacy of fixed dose combination of Nadifloxacin 1% and Adapalene 0.1% gel versus Adapalene 0.1% gel alone and Nadifloxacin Gel 1% alone in management of Acne Vulgaris

Wockhardt Limited0 个研究点目标入组 279 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male or female patients who are 13 to 45 years of age (inclusive).
•2.Patients with mild to moderate facial acne vulgaris as per IGA scale.
•3.Patients who have not used topical acne medications 14 days prior to start of study.
•4.Patients, who agree not to use any other acne medication, medicated cosmetics and/or soap, make-up that contains acne treatment additives, such as benzoyl peroxide, salicylic acid or retinol during the study (except the use of moisturizer).
•5.Patients having the willingness and ability to understand and provide informed assent/consent to participate in the study and are able to communicate with the investigator

•1.Patients with severe facial acne vulgaris as per IGA scale.
•2.Patients who are pregnant or lactating.
•3.Patients with known allergies to cosmetic, toiletry, or acne treatment products.
•4.Patients who are sensitive to any of the ingredients of study treatment.
•5.Patients who have participated in a facial treatment study within 3 weeks of study initiation.
•6.Patients exhibiting acute or chronic dermatological, medical, and/or physical conditions which would preclude application of the test materials and/or influence the outcome of the study.
•7.Patients who must use oral corticosteroids and/or oral immunosuppressive drugs (steroid inhalers or decongestant nose drops and/or eye drops are permitted).
•8.Any condition for which the Investigator determines that the patients could be placed under undue risk.

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