EVALUATION AND COMPARISON OF SAFETY AND EFFICACY OF TWO ANTI-ACNE TEST PRODUCTS ON MILD TO MODERATE ACNE.
- Registration Number
- CTRI/2011/04/001662
- Lead Sponsor
- OPLO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
1.Voluntary men/women with 4 acne lesions with nearly the same severity score and similar maturation age (per history) on the entire face.
2.Age between 18 â?? 25 years.
3.No treatment for acne in the past 1 month
4.Phototype III and IV.
5.All skin types (greasy, normal) except known significant 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.
1.Pregnant women and lactating women. In any case of suspicion a pregnancy test shall be preformed.
2.History suggestive of any hormonal problems.
3.History of allergic dermatitis or contact allergy to cosmetics,
4.Subjects on oral retinoid since 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 1.Dermatological Grading of acne lesions.Timepoint: The study will be conducted over a period of 40 hours and would involve 3 visits- <br/ ><br> [Visit 1 (0 hour), Visit 2 (16 Hours) and Visit 3(40 Hours)]. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Dermatological evaluation of cutaneous tolerance at all visits.Timepoint: 1.0 hour, 16 Hours and 40 Hours.