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A study to evaluate the Safety and Efficacy of 1 test product in reducing dark spots on the face.

Not Applicable
Completed
Registration Number
CTRI/2023/03/050575
Lead Sponsor
Himalaya Wellness Company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
42
Inclusion Criteria

1) Subject has at least 2 dark spots on the face (suntan, blemishes, sunspots and age-spots). Preferably equal number of subjects will be recruited in all indications.

2) Subjects with mild to moderate dark spots as per Investigator global assessment (IGA).

3) Subjects with oily skin having Sebumeter measurement > 180 (μg/cm2).

Exclusion Criteria

1) Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.

2) Subjects who are receiving topical or systemic treatments / undergoing skin lightening treatment.

3) Subjects receiving medications (e.g., steroids or antihistamines) which would compromise the study.

4) Subjects with chronic illness which may influence the cutaneous state.

5) Subjects having history of diabetes, acute cardiac and circulatory diseases, HIV, hepatitis.

6) Subjects using other marketed anti-acne/anti-aging/skin lightening products during the study period or in the past 6 weeks.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1) Assessment of dark spots using Investigator global assessment (IGA). <br/ ><br>2) Assessment of skin pigment using 9-point scale. <br/ ><br>3) Assessment of dark spots using Mexameter. <br/ ><br>4) Assessment of skin sebum level using SebumeterTimepoint: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 282) Assessment of skin pigment using 9-point scale. <br/ ><br>3) Assessment of dark spots using Mexameter. <br/ ><br>4) Assessment of skin sebum level using Sebumeter
Secondary Outcome Measures
NameTimeMethod
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