None listed
Conditions
Interventions
Intervention1: Membio Restore
: Mode of Usage: Apply the moisturizer evenly using gentle circular motions. Do not massage excessively. Allow full absorption of test product.
Frequency: Twice daily
Sponsors
Zydus Healthcare Limited,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 55 years at the time of consent. 2) Sex: Healthy males and non-pregnant, non-lactating female participants. 3) Participants with dry to very dry skin, defined as skin hydration values less than 40 a.u., as measured using the Corneometer CM 825. 4) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit. 5) Participants forearm must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds on or near the test site. 6) If the participant 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. 7) Participants who commit not to use medicated skincare products other than the test product for the entire duration of the study. 8) Participants are not allowed to participate in any other study until this study is complete. 9) Patients are willing to give written informed consent and are willing to come for regular follow up. 10) Participants must agree to record each use of the test product in the participant s diary card on daily basis. 11) Participant who have not participated in a similar study in the past three months.
Exclusion criteria
Exclusion criteria: 1) Participants with other dermatologic diseases whose presence or treatments could interfere with the assessment of study. 2) Participants that are pregnant and/or breastfeeding. 3) The participant has a known allergy or sensitivity to any topical product. 4) The participant has any other skin conditions i.e. cuts, scratches, ring worms, etc. which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the participant. 5) The participant is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data. 6) History of chronic illness which may influence the cutaneous state.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effectiveness of the test product in terms of change in skin hydration from baseline before usage and after usage of the test product. 2.To evaluate the effectiveness of the test product in terms of change in skin barrier function from baseline before usage and after usage of the test product. 3.To evaluate the effect of test product in terms of repair skin barrier damage following standardized tape stripping from baseline before usage and after usage of the test product Timepoint: To evaluate the effectiveness of the test product in terms of change in skin hydration using Corneometer CM 825 from baseline, before product usage on Day 01 and after usage of the test product at T20 minutes, Day 02, Day 07 and Day 15. To evaluate the effectiveness of the test product in terms of change in skin barrier function using Tewameter TM Hex from baseline, before product usage on Day 01 and after usage of the test product at T20 minutes, Day 02, Day 07 and Day 15. To evaluate the effectiveness of the test product in terms of repair skin barrier damage following standardized tape stripping induced barrier disruption using Tewameter TM Hex and Corneometer CM 825 from baseline, before product usage on Day 01 and after usage of the test product at T20 minutes, Day 02, Day 07 and Day 15. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effectiveness of test product in terms of change in skin texture i.e., skin smoothness, skin dryness, skin roughness and skin scaliness, wrinkles from baseline before usage and after usage of the test productTimepoint: Before usage of Test product on Day01, and after usage of test product at 20 minutes on Day 01, Day 02, Day 07 and Day 15;2. To evaluate the effectiveness of test product in terms of change in visual and tactile assessment of skin including skin scaliness, skin roughness, skin redness, skin itchiness, skin dryness and skin smoothness from baseline before usage and after usage of the test product.Timepoint: Before usage of Test product on Day01, and after usage of test product at 20 minutes on Day 01, Day 02, Day 07 and Day 15;3. To evaluate the effectiveness of test product in terms of change in appearance from baseline before usage and after usage of the test product.Timepoint: Before usage of Test product on Day01, and after usage of test product at 20 minutes on Day 01, Day 02, Day 07 and Day 15;4. To evaluate the effect of the test product in terms of change in desquamation index from baseline before usage and after usage of the test product.Timepoint: Before usage of Test product on Day01, and after usage of test product at 20 minutes on Day 01, Day 02, Day 07 and Day 15;5. To evaluate the effectiveness of test product in terms of change in facial photographs of improvement in scaliness and dryness from baseline before usage and after usage of the test product. (Any 5 participants)Timepoint: Before usage of Test product on Day01, and after usage of test product at 20 minutes on Day 01, Day 02, Day 07 and Day 15;6. To evaluate the effect of the test product in terms of change in sebum level from baseline before usage and after usage of the test product.Timepoint: Before usage of Test product on Day01, and after usage of test product at 20 minutes on Day 01, Day 02, Day 07 and Day 15;7. To evaluate the effect of the test product | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed