Health Condition 1: null- Acne Vulgaris
Conditions
Interventions
Intervention1: Fixed Dose Combination of Microsphere Tretinoin 0.1% and Clindamycin 1.2% Gel: once daily application at bedtime on face and effected area for 12 weeks
Control Intervention1: 1. Clindam
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female >=12 to 2. An Investigatorâ??s Static Global Assessment (ISGA) Score of 2 or greater at baseline 3. Subjects must have both: a) A minimum of 17 but no more than 40 facial inflammatory lesions; b) A minimum of 20 but not more than 150 facial non-inflammatory lesions 4. The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study. 5. Female participants must have a negative pregnancy test at screening visit and willing to use acceptable contraceptive measures during the study. 6. The ability to understand and sign written informed consent form, which must have been obtained prior to applying the study product. Subjects under the legal age of consent must provide assent and have the written informed consent of the parent or guardian.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Patient with known hypersensitivity to any of the components of the formulation. 3. Patients with severe eczema 4. Patients with any nodulo-cystic lesions at baseline. 5. History or presence at entry of regional enteritis or inflammatory bowel disease or similar symptoms. 6. A significant medical history of or are currently immunocompromised. 7. Used any investigational therapy with in the 4 weeks prior to entry. 8. Current drug or alcohol abuse at the time of entry 9. Any other condition which, in the judgment of the investigator, would put the Patient at unacceptable risk for participation in the study. 10. Patient who has clinical laboratory evaluations (including biochemistry, hematology, and complete urinalysis) that are not within the reference range for the testing laboratory at Screening and the results are deemed clinically significant by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Absolute Change in Lesion counts 2. Investigatorâ??s Static Global Assessment Success Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage change in lesion counts Timepoint: 12 weeks;2. Proportion of patients who had a Subject Global Assessment Score of 0 or 1Timepoint: 12 weeks;3. Proportion of Patients who had an ISGA Score of 0 or 1Timepoint: 12 weeks;4. Change in Vital signs, Physical Exam. & Lab ParametersTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Shailendra Sachan
Glenmark Pharmaceuticals Ltd
Outcome results
None listed