None listed
Conditions
Interventions
Intervention1: Microsphere adapalene + Clindamycin gel: 0.1% Adapalene (Microsphere) plus 1% Clindamycin gel in combination to be applied in evening and placebo (gel) in the morning for 12 weeks
Contr
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Males and non pregnant females, Age: 13 to 30 years; Mild to moderate facial acne vulgaris;a minimum of 10 but not more than 50 inflammatory lesions (papules and pustules); A minimum of 10 but not more than 100 noninflammatory lesions. (open and closed comedones); Written informed consent by patient or parent /guardian in case of minor patient.
Exclusion criteria
Exclusion criteria: Pregnant and nursing women; Females not using effective form of contraception before admission to study & during course of study; Patient not receiving any topical or systemic treatment for acne for last 2 weeks; Patients with nodular acne lesions (>2); Secondary acne and severe acne (acne fulminans, acne conglobata; Inflammatory acne > 50; Patients with acne excoriata or having psychological disturbances;Known dermal sensitivity to light (photosensitivity); Hypersensitivity or allergy to adapalene or other retinoids or Vitamin A derivatives (eg. isotretinoin, tretinoin, etretinate) and clindamycin or lincosamide group of antibiotics or any other component of study medication;History of other skin conditions (eg. eczema, dermatitis, etc. that require the use of interfering topical or systemic therapy); Patients with history of hirsutism or irregular menses or infertility and clinical examination suggestive of PCOS or any other endocrinological disorder; Patients with morbid obesity (BMI ≥ 30); Patients with history of regional enteritis, ulcerative colitis or antibiotic associated colitis; Immunocompromised states and patients with systemic infections; Patients who had participated in a new drug study in the past 6 months; Patients with severe cardiac, hepatic, renal or cerebrovascular disease, malignancy, chronic uncontrolled systemic diseases e.g. diabetes, hypertension, asthma, collagen disorders, etc or any other serious medical illness; Any other condition that in the opinion of the investigator did not justify the patient?s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean percent reduction from the baseline in the number of inflammatory, non-inflammatory lesions and total lesions of the face at the end of treatment (week12), the percentage of patients showing recurrence of acne lesions, defined as more than 50 % increase in the lesions at 6 months as compared to the number of lesions lost at end of 12 weeks of treatment. Mean percent increase in the inflammatory and the non inflammatory lesions after treatment was evaluated each month up to a period of six months and the percentage of patients the treatment success (defined as IGA severity score of 0 or 1 at end of treatment) was maintained and there was no increase in the grade of acne within six months follow up period.Timepoint: Baseline, Weeks 4,8,12,24 and 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability.Timepoint: End of study | — |
Countries
India
Contacts
Public ContactChandrashekhar S Bolmall
Medical Services Dept
Outcome results
None listed