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

Phase 4

Completed

Brief Summary: An open-label, single-arm, single-centre clinical observational study to evaluate Safety and Efficacy of HSTF-022206 in Healthy Adult Subjects in adult human subjects from 18 to 55 years with facial dark spots. Subjects will be pre-screened by the study team. Subjects will be telephonically contacted by recruiting team prior to the enrolment visit. Subjects will be instructed during screening (prior to enrolment) not to wear any facial make-up during study visit to facility. The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits. âœ“ Visit 1 (Day 1): Screening and Enrolled Day 1 âœ“ Visit 2 (Day 7): Product usage Period, Evaluation Visit âœ“ Visit 3 (Day 14): Product usage Period, Evaluation Visit âœ“ Visit 4 (Day 28): Product usage Period End, End of the Study visit.

Recruitment & Eligibility

Inclusion Criteria

1.Age: 18 to 55 years (both inclusive) at the time of consent.
Sex: Healthy non-pregnant/non-lactating females and Males.
Subject has facial dark spots includes sun-tan, blemishes, sunspots, and age spots.
Female of childbearing potential must have a reported negative pregnancy during screening.
Subject is generally in good health.
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.
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.

Primary Outcome Measures

Secondary Outcome Measures

Name	Time	Method
To evaluate the product safety of skin by local intolerance	evaluation by investigator and occurrence AEs and SAEs.

Locations (1): TrialGuna Private Limited
🇮🇳
Bangalore, KARNATAKA, India
TrialGuna Private Limited
🇮🇳Bangalore, KARNATAKA, India
Dr Sohandas Shetty
Principal investigator
8867125414
drsohanshetty@yahoo.co.in