None listed
Conditions
Interventions
Intervention1: Sofinox Cream - Sodium Fusidate I.P. equivalent to Fusidic Acid I.P 2%w/w and Ageless gel
Adapalene 0.1% w/w
: Apply ½ Finger Tip Unit ? 1 Finger Tip Unit of Sofinox Cream on the aff
Sponsors
Apex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntary men/women with inflammatory acne lesions (5 - 25) on entire face. 2. Age between 18 ? 55 yr 3. No treatment for acne in the past 1 month 4. Phototype III and IV. 5. All skin types (greasy, normal) except sensitive skin. 6. Accepting not to use products with the same end benefit during the entire study duration. 7. For whom the Investigator considers that the compliance will be correct. 8. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 9. Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
Exclusion criteria
Exclusion criteria: 1. Pregnant women (as confirmed by UPT) and lactating women. 2. History suggestive of any hormonal problems. 3. History of allergic dermatitis or contact allergy to cosmetics, 4. Subjects on oral retinoid in the past 3 months. 5. Hypersensitivity to any cosmetic product, raw material. 6. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures. 7. Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month). 8. Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of inflammatory acne count.Timepoint: Visit 1 (Day 0), Visit 2 (1 week), Visit 3 (2 weeks), Visit 4 (4 weeks), Visit 5 (6 weeks), Visit 6 (8 weeks), Visit 7 (10 weeks), Visit 8 (12 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatological evaluation of cutaneous tolerance.Timepoint: Visit 1 (Day 0), Visit 2 (1 week), Visit 3 (2 weeks), Visit 4 (4 weeks), Visit 5 (6 weeks), Visit 6 (8 weeks), Visit 7 (10 weeks), Visit 8 (12 weeks). | — |
Countries
India
Contacts
Public ContactMr Madhavan S
Outcome results
None listed