To evaluate the safety & efficacy of Facial Oxylife Spot Reduction Bleach System

Not Applicable

Completed

Registration Number: CTRI/2018/02/011928

Lead Sponsor: Dabur India Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Female Adult Subjects in general good health with age group of 18 to 60 years. Subjects who have not undergone any bleaching or facial procedure in past 6 weeks.

2. Subjects willing to give a voluntary written informed consent for the participation in study and also photography release and agree to come for regular follow up.

3. Subjects willing to abide by and comply with the study protocol.

4. Subjects who are willing not to participate in any other clinical study during participation in the current study.

5. Subjects who will qualify the sensitivity test will be enrolled in the study.

Exclusion Criteria

1. A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients, or any ingredient of the test product.

2. Present/current of intense sun exposure.

3. Female volunteers with positive pregnancy test.

4. Presence of any underlying clinically significant uncontrollable medical conditions

5. Subject having active skin diseases (e.g. mild, moderate to severe acne vulgaris on the face or nodulocystic acne, psoriasis, active atopic dermatitis, lichen planus pigmentosus/Ashy dermatosis, pigmented contact dermatitis and active seborrhoeic dermatitis, tinea faciei or other cutaneous manifestations), which may interfere with the test readings.

6. Subject on systematic medications (e.g. steroids, anti-oxidant) which may compromise the study.

7. Subjects who have excessive facial hair

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Reduction in skin spots in comparison to baseline <br/ ><br>2. Reduction in skin pigmentation in comparison to baseline. <br/ ><br>Timepoint: At Day 1, Day 3, Day 7 and Day 14

Secondary Outcome Measures

Name	Time	Method
1. Assessment of bleaching system in improving glow and radiance. <br/ ><br>2. Assessment of bleaching system in improving Detanning. <br/ ><br>3. Assessment of bleaching system in improving skin clarity. <br/ ><br>4. Assessment of bleaching system in improving skin colour. <br/ ><br>5. To evaluate the safety and tolerability of bleaching system. <br/ ><br>Timepoint: At Day 1, Day 3, Day 7 and Day 14