CTRI/2023/03/050239
Completed
未知
A Clinical Study to Evaluate Safety, Efficacy and In-Use Tolerability Study of HDSC-022209 in Healthy Adult Human Subjects in Reduction in Facial dark Spots.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Himalaya Wellness Company
- Enrollment
- 42
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 preferably equal ratio of 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 is not undergone any cosmetic procedures or any medication for the treatment of acne 3 months prior to study enrolment.
- •7\)Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
- •8\)Willing to forgo use of all other topical acne medications or antibiotics during the study period or any treatment duration of the study
- •9\)Subject is able to forgo changes in baseline medications and nutritional supplements, any other anti\-acne facial cream, powder, face mask etc. during the study period.
- •10\)If the female subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non\-childbearing potential if they are surgically sterile, have been post\-menopausal for at least 1 year or have had a tubal ligation.
Exclusion Criteria
- •1\)Subject has a history of allergy or sensitivity to the test product 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.
- •4\)Subject has taken any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- •5\)Subject using any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- •6\)Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
- •7\)Subject has a history of alcohol or drug addiction.
- •8\)Subject has a history of prior use of scar removal, spots reduction, skin radiance or wrinkles laser treatment within 3 months.
- •9\)Any other condition which could warrant exclusion from the study, as per the dermatologistâ??s/Investigatorâ??s discretion.
- •10\)Subject has a history of chronic illness which may influence the cutaneous state.
Outcomes
Primary Outcomes
Not specified
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