Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Intervention1: Clindamycin Phosphate 10 mg/g and Benzoyl Peroxide 50 mg/g Gel: Subject have to apply a thin film of gel over entire area of affected skin of face, using fingertips once daily, in the e
Sponsors
Morningside Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male or non-pregnant female aged more than or equal to 12 and less than or equal to 40 years with a clinical diagnosis of Acne vulgaris. 2. On the face, more than or equal to 25 non-inflammatory lesions (i.e., open and closed comedones) AND more than or equal to 20 inflammatory lesions (i.e., papules and pustules) AND less than or equal to 2 nodules. 3. Investigatorâ??s Global Assessment (IGA) of acne severity grade 2, 3 or 4. 4. Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period. 5. If female of childbearing potential, willing to use an acceptable form of birth control during the study. 6. Willing to provide written informed consent or assent, as applicable.
Exclusion criteria
Exclusion criteria: 1. Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). 2. Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g. chloracne and drug induced acne). 3. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well-trimmed moustaches are allowed. 4. History of hypersensitivity or allergy to clindamycin or lincomycin or benzoyl peroxide and/or any of the study medication ingredients. 5. Use within 6 months prior to baseline (Randomisation) of oral retinoids (e.g. Accutane) or therapeutic vitamin A supplements of greater than 10,000 units per day (multivitamins are allowed). 6. Use for less than 3 months prior to baseline (Randomisation) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study. 7. Use on the face within 1 month prior to baseline (Randomisation) of 1) cryodestruction or chemodestruction, 2) dermabrasion / microdermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, 6) X-ray therapy, or 7) chemical or laser peel. 8. Use within 1 month prior to baseline (Randomisation) of 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents. 9. Use within 2 weeks prior to baseline (Randomisation) of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers/shampoo or 6) topical antibiotics. 10. Subjects who have received neuromuscular blocking agents within 14 days prior to study entry (Randomisation). 11. Used astringents and toners for less than 2 weeks prior to the start of the study. The subject must have had an established regimen for at least 2 weeks prior to enrolment and must not have anticipated changing their regimen during the conduct of the entire study. 12. Used abradants, facials, peels containing glycolic or other acids, masks; washes or soaps containing benzoyl peroxide, salicylic acid, or sulfacetamide sodium; non-mild facial cleansers, moisturizers that contained retinol, salicylic acid or α- or β-hydroxy acids within the previous 2 weeks. 13. Concomitant use/planned to use of mega-doses of certain vitamins (such as mega-doses of vitamin D [more than 2000 IU per day], vitamin B6 [more than 2 mg] or vitamin B12 [more than 1 mg per day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital. 14. Use of tanning booths or tanning lamps within 1 week prior to Baseline and an unwillingness to refrain from use during the study. 15. A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months. 16. Have a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. 17. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies. 18. Subjects who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint- . Mean percent change from baseline to week 11 for inflammatory (papules and pustules) lesions count Secondary Efficacy Endpoints: .Mean percent change from baseline to week 11 in the non-inflammatory lesion count. .Percentage of subjects with clear or almost clear at week 11 by IGA score [Grade 0 or 1] as compared to baseline Timepoint: At baseline, week 2, week 5, week 8 and week 11. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoints: .Treatment Emergent Adverse events (TEAEs) .Local tolerability assessments Timepoint: At baseline, week 2, week 5, week 8 and week 11. | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed