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

A clinical observational study to evaluate Safety and Efficacy of HSTF-022206 in Healthy Adult Subjects in reduction of facial dark spots.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050307
Enrollment
100
Registered
2023-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Himalaya Wellness Company
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1.Reduction in dark spots 2.Improvement of PGA scoring 3.Change in skin appearance 4.Safety of skinTimepoint: Day 1,Day 7,Day 14,Day 28

Secondary

MeasureTime frame
To evaluate the product safety of skin by local intolerance evaluation by investigator and occurrence AEs and SAEs.Timepoint: Day 1,Day 7,Day 14,Day 28

Countries

India

Contacts

Public ContactMeena Dalal

Trial Guna Pvt Ltd

drsohanshetty@yahoo.co.in8867125414

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026