None listed
Conditions
Interventions
Intervention1: Test Product 1: Control (Base cream without any moisturizing ingredients)
Test Product 2: 5% Fructo-Oligosaccharide (5% FOS)
Test Product 3: 5% Galacto-Oligosaccharide (5% GOS)
Test
Sponsors
Tata Chemicals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effect on skin hydration using Corneometer 2. Effect on skin barrier function using TEWAmeter 3. effect on skin elasticity using Cutometer 4. effect on skin surface using pH meter 5. effect on skin physical parameter by Dermatologist/dermatologist validated scorer scale for dryness, roughness, redness/erythema, burning, itching and stinging 6. effect of products for change in skin microbial flora by swab collection 7. subject response index after applicationTimepoint: 1 to 4. Baseline i.e. Day 1 before application to T0.5 hour, T2 hours, T4 hours, T8 hours, T12 hours on Day 1, T24 hours on Day 2, Day 8, Day 14 post application. 5. From baseline i.e. Day 1 (before application) to Day 14 (end of study). 6.From baseline i.e. Day 1 (before application) to Day 14 (end of study). 7. On Day 1, Day 8 and Day 14 (end of study). | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed