Health Condition 1: null- Acne Vulgaris Health Condition 2: L700- Acne vulgaris
Conditions
Interventions
Intervention1: Nadifloxacin 1% and Adapalene 0.1%: Nadifloxacin 1% + Adapalene 0.1% Gel has to be evenly applied over the affected area of the face once daily in the evening after washing face and bef
Sponsors
Wockhardt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from base line to week 8 in the inflammatory lesions of acne (pustules, and nodules/nodulocystic lesions) 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Amey Mane
Wockhardt Limited
Outcome results
None listed