This is a comparative, double blind study of fixed dose combination of nadifloxacin and adapalene with adapalene and nadifloxacin alone for treatment of acne
- Conditions
- Health Condition 1: null- Acne VulgarisHealth Condition 2: L700- Acne vulgaris
- Registration Number
- CTRI/2014/08/004908
- Lead Sponsor
- Wockhardt Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 279
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change from base line to week 8 in the inflammatory lesions of acne (pustules, and nodules/nodulocystic lesions) <br/ ><br>2. Change from base line to week 8 in the non-inflammatory lesion of acne [open (blackheads) or closed (whiteheads) comedones count]Timepoint: Day 1, Day 8, Day 15, Day 29 and Day 57
- Secondary Outcome Measures
Name Time Method Quality of Life assessmentTimepoint: Day 57;The proportion of success according to IGA scale for assessing overall acne severityTimepoint: Day 1, Day 8, Day 15, Day 29 and Day 57