A single centre, site randomized, double-blind, comparative study to evaluate the impact of topical application of FOS and GOS on skin hydration, barrier function, and microbiome regulation in human adult subjects with dry, flaky skin, otherwise healthy.

Tata Chemicals Ltd0 个研究点目标入组 33 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Age 30 to 55 years (both inclusive) at the time of consent.
•2.Sex: Male or non-pregnant/non-lactating females.
•3.Females of Childbearing potential must have a negative urine pregnancy test performed on screening visit.
•4.Subject who is having good general health as per medical history.
•5.Subject with dry skin evaluated by Corneometer reading in between 30 to 40 a.u. unit on each forearm.
•6.Subject with mild to moderate dry skin will be included as determined by dermatologist/dermatologist validated scorer using 4 point scale1.
•7.Subject with willingness to avoid usage of soaps, cleansers or any other moisturizers/lotions/creams/oils other than the test product on the test site 7 days prior and throughout the entire study duration.
•8.Subject must be able to understand and provide written informed consent to participate in the study.
•9.Subject should be willing and able to follow the study directions to participate in the study.

•1.Subject with current use or use in the past 3 months of antimicrobial or steroidal drugs or any prescription medication or supplementâ??s.
•2.Subject with medical history (past and present) of significant dermatologic diseases or conditions, such as atopy, psoriasis, eczema, atopic dermatitis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes.
•3.Subject with history of medical conditions affecting immune status (e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV).
•4.Subject with application of any topical products (cream /lotion/soap/Cleanser/coconut oil/mustard oils/ dairy products or any other cosmetic applications, mehndi, tattoo, scar and excessive terminal hair) for 7 days before the study and during the study.
•5.Female volunteers who identified Pregnant during the study period or are lactating.
•6.Subject with history of drug and alcohol abuse.
•7.Subject participating in a similar clinical study, currently or during the previous 90 days.
•8.Subject with any relevant surgical treatment during the previous two months or planned during the study.
•9.Any subject, in the investigators opinion not considered suitable for enrollment.

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