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Observational study to evaluate safety and efficacy of HSTF 02206 in reduction of dark spots

Phase 4
Completed
Registration Number
CTRI/2023/03/050307
Lead Sponsor
Himalaya Wellness Company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

1.Age: 18 to 55 years (both inclusive) at the time of consent.

2. Sex: Healthy non-pregnant/non-lactating females and Males.

3. Subject has facial dark spots includes sun-tan, blemishes,

sunspots, and age spots.

4. Female of childbearing potential must have a reported negative

pregnancy during screening.

5. Subject is generally in good health.

6. Subject has not undergone any cosmetic procedures or any

medication for the treatment of acne or facial dark spots 3

months prior to study enrolment and willing to forgo any

treatment duration of the study

Exclusion Criteria

1.Subject has a history of allergy or sensitivity to the test treatment ingredients

2.Subject who has a history of allergy with products containing

turmeric or any known ingredients.

3. Subject who has pre-existing or dormant dermatologic

conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis,

acne, acne rosacea or any other) that could interfere with the

subject selection and outcome of the study as determined by

the Investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Reduction in dark spots <br/ ><br>2.Improvement of PGA scoring <br/ ><br>3.Change in skin appearance <br/ ><br>4.Safety of skinTimepoint: Day 1,Day 7,Day 14,Day 28
Secondary Outcome Measures
NameTimeMethod
To evaluate the product safety of skin by local intolerance <br/ ><br>evaluation by investigator and occurrence AEs and SAEs.Timepoint: Day 1,Day 7,Day 14,Day 28
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