Evaluation of Efficacy and Safety of the topical premixed formulation of Nadifloxacin 1% + Adapalene 0.1% in the treatment of subjects with Acne vulgaris (Phase III Study)

Wockhardt Limited0 个研究点目标入组 100 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 subject suffering from mild to moderate acne on the face
•2. Subject with mixed non inflammatory comedones and inflammatory papulo-pustular lesions
•3. Subject, 12 Years of age and above
•4. Subject willing to apply only the investigational product as advised and willing to come to the center for follow up visits as scheduled in the study
•5. Subject willing to sign an Informed consent form

•1. Subject with known hypersensitivity to individual ingredients viz. Nadifloxacin or Adapalene or any other closely related agent from quinolone or retinoid class of drugs
•2. Subject less than 12 years of age
•3. Subject suffering from severe acne requiring systemic drugs for management of acne
•4. Subject with only non inflammatory comedones requiring only topical retinoid application
•5. Subject who has used any other retinoid for management of facial acne in past 4 weeks
•6. Subject who has used any systemic or topical antibiotic in past two weeks
•7. History or presence of any major illness of the liver, kidney, uncontrolled diabetes, uncontrolled hypertension or any central nervous system or cardiovascular system or any other systemic disorder that interferes with the overall health of the subject
•8. Woman subject who is pregnant/nursing/intending pregnancy during the trial. OR woman not using effective physical or chemical contraception.

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