EVALUATION OF THE DARK SPOTS LIGHTENING EFFICACY AND TOLERANCE OF TEST PRODUCT IN WOMEN WITH DARK SPOTS

Not Applicable

Completed

• Registration Number: CTRI/2011/07/001908
• Lead Sponsor: AMRA Remedies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-10-03
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

1.Voluntary women with well defined hyperpigmented patch of not less than 2 cms on face (epidermal pigmentation).

2.Between 18 and 45 years.

3.Photo type IV and below.

4.Presenting healthy skin on face.

5.Accepting not to use products with the same end benefit or containing sunscreen during the entire study duration.

6.Willing to avoid unusual sun exposure as far as possible for 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 and lactating women or women planning pregnancy.

2.Skin allergy antecedents or atopic subject.

3.Hypersensitivity to any cosmetic product, raw material.

4.Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.

5.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).

6.Subject in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical evaluation by MASI scale for pigmentation SIAscopy using cosmetrics on pigmented site for melanin content <br/ ><br>Self Evaluation Questionnaire to get volunteer perception of productTimepoint: at Visit 1 (Day 0), Visit 2 (Day 30)and Visit 3 (Day 60). <br/ ><br> <br/ ><br>at Visit 1 (Day 0), Visit 2 (Day 30)and Visit 3 (Day 60). <br/ ><br> <br/ ><br>at Visit 2 (Day 30)and Visit 3 (day 60). <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Dermatological evaluation for skin tolerance aTimepoint: Day 30 and Day 60.