Health Condition 1: null- Mild to Moderate Acne Vulgaris
Conditions
Interventions
Intervention1: Clindamycin 1% / Benzoyl Peroxide 5% Topical Gel (Cadila Healthcare Limited, India): Once Daily on the affected area for 11 Weeks
Control Intervention1: Duac® Topical Gel (Stiefel Labor
Sponsors
Cadila Healthcare Limited
BA Research India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be Healthy male or non-pregnant non-lactating female subjects 13 to 40 years of age; 2. Be able to provide signed informed consent. Subjects of 18 years or older must provide IEC/IRB approved written informed consent. Subjects of less than 18 years age must have IEC/IRB approved written informed consent from a parent or legal guardian. Subjects of 13 ¨C 17 years age must complete an IEC/IRB approved assent form for minors. 3. Have clinical diagnosis of Acne Vulgaris and on the face, ¡Ý 25 non- inflammatory lesions (i.e. open and closed comedones) AND ¡Ý20 inflammatory lesions (i.e. papules and pustules) AND ¡Ü 2 nodulocystic lesions (i.e. nodules and cysts). 4. Local Tolerance grading 0, 1 or 2. 5. Investigator¡¯s Global Evaluation (IGE) of acne severity grade 2 or 3. 6. Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period. 7. All subjects will be evaluated by the principal or sub-investigator physician during a pre-study medical evaluation performed within 15 days of the initial dose of study medication which will include: 8. a normal or non-clinically significant physical examination, including vital signs (blood pressure, heart rate, respiratory rate and temperature); 9. within normal limits or non-clinically significant laboratory evaluation results for the clinical laboratory tests. 10. Willing and able to understand the requirements of the study, abide by the restrictions, apply the medication as instructed, and return for the required study visits. 11. Be in good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations. 12. Have used the same brand of make-up for a minimum period of 2 weeks prior to randomization, for subjects who use make-up, and agree to not change make-up brands or types during the study.
Exclusion criteria
Exclusion criteria: 1. Be pregnant or breast feeding. 2. Have presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris; which includes, on the face: 2 nodulocystic lesions, rococo, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis. 3. Excessive facial hair (e.g. beards, sideburns, moustaches, etc) that would interfere with the diagnosis or assessment of acne vulgaris 4. Have a history of hypersensitivity to clindamycin, lincomycin, benzoyl peroxide, or any component of the study medication formulations. 5. Use within 6 months prior to randomization of oral retinoids or therapeutic Vitamin A supplements of greater than 10,000 units/day 6. Have received treatment with systemic antibiotics or steroids within 4 weeks of study start or topical antibiotics or steroids within 2 weeks of study start 7. Use on the face within one month prior to randomization or during the study of: a) cryodestruction or chemodestruction, b) dermabrasion, c) photodynamic therapy, d) acne surgery, e) intra lesional steroids, f) x-ray therapy 8. Use within one month prior to randomization of, a) spironolactone, b) systemic steroids, c) systemic antibiotics, d) systemic treatment for acne vulgaris or e) Systemic Anti inflammatory agents. 9. Have received treatment with topical anti-acne medications within the 2 weeks prior to the study (topical steroids, topical retinoids, topical acne treatments including over the counter preparations, topical anti inflammatory agents , medicated cleansers or topical antibiotics 10. Have any systemic or dermatologic disease that may effect the evaluation of study results. 11. Have a history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis. 12. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies. 13. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight. 14. Subjects who consume excessive amounts of alcohol (more than 3-4 drinks per day), abuse drugs, or have any condition that would compromise compliance with this protocol. 15. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent reduction from baseline to Day 77 in the number of inflammatory acne lesionsTimepoint: Mean percent reduction from baseline to Day 77 in the number of inflammatory acne lesions | — |
Secondary
| Measure | Time frame |
|---|---|
| mean percent change in no. of non-inflammatory lesions, mean percent change in no. of total lesion count and change in Investigator AssessmentTimepoint: From Baseline to End of Study Visit | — |
Countries
India
Contacts
Public ContactMr Chirag Shah
Outcome results
None listed