A Randomized, Double-blind, Three-arm, Comparative, Parallel, Proof-of-Concept Study to Evaluate Safety and Efficacy of Collagen containing Test Products in Healthy Adult Human Subjects

Bright LifeCare Private Limited0 sites56 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

February 25, 2023

Last Updated

3 years ago

Study Type

Interventional

Sponsor

Bright LifeCare Private Limited

•1\)Age: 38 to 50 years (both inclusive) at the time of consent.
•2\)Sex: Healthy non\-pregnant/non\-lactating females.
•3\)Females of childbearing potential must have a self\-reported negative pregnancy test.
•4\)Subject are generally in good health.
•5\)Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
•6\)Subject has a score of at least â??mild skin agingâ?? based on PGA at screening visit.
•7\)Subject with Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
•8\)Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
•9\)Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
•10\)Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.

•1\)Subject has a history of allergy or sensitivity to the test treatment ingredients.
•2\)Subjects who has a history of Fish allergy.
•3\)Subjects who have pre\-existing or dormant dermatologic conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis, acne or any other) that could interfere with the outcome of the study as determined by the investigator.
•4\)Subject has used 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 has applied 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 is currently pregnant/breastfeeding.
•8\)Subject has a history of prior use of skin radiance or wrinkle laser treatment within 3 months.
•9\)Subject has a history of alcohol or drug addiction.
•10\)Any other condition which could warrant exclusion from the study, as per the dermatologistâ??s/investigatorâ??s discretion.