Health Condition 1: L908- Other atrophic disorders of skin
Conditions
Interventions
Intervention1: Topical Cream containing 0.1% Pinorox : Mode of Usage: Apply a coin size (approximately 1g) amount of the test treatment to the face and gently massage it until fully absorbed.
Frequenc
Sponsors
Ambe Phytoextracts Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 35 to 55 years (both inclusive) at the time of consent. 2) Sex: Adult male and female having Crow s feet area wrinkles, fine lines, facial dark spots. 3) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit. 4) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 3 months. 5) Subjects are not allowed to participate in any other study until this study is complete. 6) Subjects must be willing and able to follow the study directions and to return for all specified visits with the product. 7) Subjects must agree to record each use of the test products in the subject s diary card on daily basis. 8) Subjects must agree to record medication use during the study
Exclusion criteria
Exclusion criteria: 1) Subjects who are on steroids for last six months. 2) Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last three months. 3) Subjects who are on product which contains kojic acid, glycolic acid, niacinamide, alpha arbutin, Vitamin C and other skin ageing product. 4) Subjects with other dermatologic diseases whose presence or treatments could interfere with the assessment of study. 5) Subjects that are pregnant and/or breastfeeding. 6) The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances. 7) Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure. 8) The subject 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 subject. 9) The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results. 10) The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data. 11) Any other condition which could warrant exclusion from the study, as per the dermatologist s/investigator s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test treatment(s) by assessing change in 1. skin elasticity and firmness 2. change in skin texture - Crow s feet area wrinkles, fine lines, pores, roughness, dryness, smoothness 3. change in skin pigmentation and dark spots 4. change in skin colour parameters L, a, b, and ITA, from baseline to post-treatment, within each treatment group and across treatment groups. Timepoint: Improvement in 1. skin elasticity and firmness through Cutometer Dual MPA 580 2. skin texture evaluated through Visioscan VC 20 Plus 3. skin pigmentation and dark spots evaluated through Mexameter MX 18 4. skin colour parameters L, a, b, and ITA evaluated through Skin Colorimeter CL 400 from baseline on Day 01 to post treatment assessments on Day 01 at T30 mins, Day 30 and Day 60, assessed within each treatment group and across treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effectiveness of the test treatments by assessing change in skin dryness, redness, fine wrinkling/lines, coarse wrinkles, laxity, roughness and sallowness from baseline to post-treatment, within each treatment group and across treatment groups.Timepoint: Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60;2. To evaluate the effectiveness of the test treatments by assessing change in skin wrinkles and fine lines from baseline to post-treatment, within each treatment group and across treatment groups.Timepoint: Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60;3To evaluate the effectiveness of the test treatments by assessing change in skin pigmentation from baseline to post-treatment, within each treatment group and across treatment groups.Timepoint: Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60;4. To evaluate the effectiveness of the test treatments by assessing change in skin hydration from baseline to post-treatment, within each treatment group and across treatment groups.Timepoint: Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60;5. To evaluate the effectiveness of the test treatments by assessing change in skin glow from baseline to post-treatment, within each treatment group and across treatment groups.Timepoint: Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60;6. To evaluate the effectiveness of the test treatments by assessing change in facial photographs from baseline to post-treatment, within each treatment group and across treatment groups.Timepoint: Day 01 (pre treatment), Day 30, Day 60;7. To evaluate the effectiveness of the test treatments by assessing change in product perception questionnaire regarding reduction in dark spots, skin appearance, skin hydration, skin texture, reduced fine lines and wrinkles from baseline to post-treatment, within each treatment group and across treatment groups.Timepoint: Day 01 (pre treatment), Day 30, Day 60;2. To evaluate the effectiveness of the test treatments by | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed