Health Condition 1: null- acne vulgaris
Conditions
Interventions
Intervention1: Nadifloxacin 1% + Adapalene 0.1% Gel: Nadifloxacin 1% + Adapalene 0.1% Gel has to be evenly applied over the affected area of the face once daily in the night after washing face and bef
Sponsors
Wockhardt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in number of non-inflammatory lesions (comedones) Reduction in number of inflammatory lesions (papules, pustules, nodules) Reduction in total number of acne lesions Reduction in the severity of acne as per Combined Acne Severity Classification Improvement in global assessment scale of acne towards normal clear skin Timepoint: All the parameters will be checked before and after 8 weeks of treatment with study medication as the active treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Recording of any adverse drug reactions observed by the Investigator and / or reported by the subject and - Any clinically significant changes in laboratory parameters Timepoint: All the parameters will be checked before and after 8 weeks of treatment with study medication as the active treatment | — |
Countries
India
Contacts
Public ContactSeema Bawangade
Wockhardt Limited
Outcome results
None listed