Health Condition 1: null- Mild to moderate acne vulgaris
Conditions
Interventions
Intervention1: Sofinox cream and Adapalene cream: Sofinox Cream (Sodium Fusidate IP equivalent to Fusidic Acid 2.0% w/w) cream one finger tip unit(1FTU or 0.5 gm) to be applied twice daily (morning &
Sponsors
Apex Laboratories Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: - Skin phototype III-V (Fitzpatrick) - Acne prone subjects showing the presence of mild to moderate facial acne vulgaris (Grade 2-7 on Leeds Acne Grading scale), presenting at least 15 inflammatory lesions and at least 25 non-inflammatory lesions on the face - Female participants with child bearing potential must have a negative urine pregnancy test at screening visit and willing to use acceptable contraceptive measures during the study.
Exclusion criteria
Exclusion criteria: - Patients with any nodulo-cystic lesions at baseline - Secondary acne and severe acne (acne fulminans, acne conglobata) - Patients with acne excoriata or having psychological disturbances Known hypersensitivity to the study drug or constituents - Any topical or systemic treatment that could interfere with the study treatments/assessments (antibiotics, corticosteroids, retinoids, antiinflammatory drugsâ?¦) within the last 4 weeks prior to participation in the study, and during the study - Any surgical treatment on the test areas - Use of hormonal contraceptives solely for the treatment of acne - Use of prohibited medications prior to the start and unwillingness to refrain from the use during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Counting of cutaneous inflammatory acne lesions - Average inflammatory lesion sizeTimepoint: - Counting of cutaneous inflammatory acne lesions on day 1, 15, 29, 43, 57, 71, 85, 106 - Average inflammatory lesion size on day 1, 15, 29, 43, 57, 71, 85, 106 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Self-evaluation questionnaire by the subjects - Investigators assessment of improvement in acne on the basis of Leeds acne grading scale (Photographic scale) - Recurrence of target inflammatory acne lesions post subsidence - Skin conductivity with Corneometer®Timepoint: - Self-evaluation questionnaire by the subjects at D1, D43 and D85 - Investigators assessment of improvement in acne on the basis of Leeds acne grading scale (Photographic scale) on days 1, 15, 29, 43 57, 71 and 85 - Recurrence of target inflammatory acne lesions post subsidence on days 29, 43 57, 71 and 85 - Skin conductivity with Corneometer® on days 1, 15, 29, 43 57, 71 and 85 | — |
Countries
India
Contacts
Public ContactDr Aalok Makker
CIDP Biotech India Pvt. Ltd
Outcome results
None listed