EVALUATION AND COMPARISON OF ANTI-ACNE TEST PRODUCTS ON MILD TO MODERATE ACNE
Not Applicable
Completed
- Conditions
- With inflammatory acne lesions on entire face.
- Registration Number
- CTRI/2011/05/001721
- Lead Sponsor
- Apex Laboratories Pvt Ltd
- Brief Summary
Trial has been started .
This is a test under dermatological control, multicentric, double blinded, randomized, comparative – versus initial state, and between groups.
**At Visit 1,** baseline inflammatory acne count and digital photographs were taken. Baseline dermatological scoring was done.
Dermatological evaluation for cutaneous tolerance was done by a Dermatologist. Inflammatory acne count and digital photographs were taken at all visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 91
Inclusion Criteria
- 1.Voluntary men/women with inflammatory acne lesions (5.
-
- 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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of inflammatory acne count. 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 Outcome Measures
Name Time Method Dermatological evaluation of cutaneous tolerance. 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).
Trial Locations
- Locations (2)
C.L.A.I.M.S. Pvt. Ltd.
🇮🇳Mumbai, MAHARASHTRA, India
Skin Clinic
🇮🇳Nashik, MAHARASHTRA, India
C.L.A.I.M.S. Pvt. Ltd.🇮🇳Mumbai, MAHARASHTRA, IndiaDr Rajiv JoshiPrincipal investigatorrsjdr@rediffmail.com