None listed
Conditions
Interventions
Intervention1: Gel B: Frequency: Twice a day on clean skin
Duration: for 60 days
Route of
Administration: Topical application.
Control Intervention1: Gel A: Frequency: Twice a day on clean skin
Dur
Sponsors
Green Mountain Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 35 to 55 years (both inclusive) at the time of consent. 2) Sex: Healthy and non-pregnant/non-lactating females. 3) Subjects who are generally in good health as determined by/form recent medical history. 4) Female of child bearing capacity must have a self-reported negative pregnancy test. 5) Subjects having mild to moderate crows’ feet wrinkles. 6) Subjects having a score of at least “mild skin aging ? based on PGA at screening visit. 7) Subjects having a score of at least “mild skin pigmentation ? based on Skin Pigmentation Score at screening visit. 8) Subjects having Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator. 9) Subjects who are willing to forgo cosmetic procedures for the duration of the study. 10) Subjects who are able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study. 11) Subjects who are willing not to introduce any new soaps, cleansers, lotions, creams, or any other face products etc. for the duration of the study. 12) Subjects who are willing to give written informed consent and are willing to follow the study procedure. 13) Subjects who commit not to use medicated/ prescription anti-ageing and skin brightening products or any other anti-ageing and skin brightening products other than the test products for the entire duration of the study. 14) Subjects who are willing to use test products throughout the study period.
Exclusion criteria
Exclusion criteria: 1) Subjects having a history of allergy or sensitivity to the test treatments ingredients. 2) 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. 3) Subjects who have 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. 4) Subjects who have applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study. 5) Subjects not willing to avoid unprotected sun or other UV radiation exposure during the study period. 6) Subjects having a history of alcohol or drug addiction. 7) Subjects who have 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. 8) Subjects who have applied any topical retinoids or glutathione within 2 weeks of the screening visit or anticipates having to use at any point during the study. 9) Subjects not willing to avoid unprotected sun or other UV radiation exposure during the study period. 10) Subjects who are currently pregnant/breastfeeding or planning to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the effectiveness of the test products in terms of change in Skin Elasticity from baseline using Cutometer Dual MPA 580. 2. To assess the effectiveness of the test products in terms of change in CIE L, a b, ITA angle, skin brightness, skin pigmentation using Skin Colorimeter CL 400. 3. To assess the effectiveness of the test products in terms of change in Skin Glow using Skin Glossymeter GL 200. 4. To assess the effectiveness of the test products in terms of change in crow’s feet area wrinkles, fine lines, skin texture – roughness, dryness, wrinkles, smoothness using Visioscan (C+K Instrument). 5. To assess the effectiveness of the test products in terms of change in facial photographs using digital photographs. 6. To assess the effectiveness of the test products in terms of change in wrinkles, fine lines & pores using Image-pro Software. Timepoint: 1. Day 01, Day 30, Day 60 2. Day 01, Day 30, Day 60 3. Day 01, Day 30, Day 60 4. Day 01, Day 30, Day 60 5. Day 01, Day 60 6. Day 01, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the consumer perception of the test products regarding the test product’s effect on skin firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes & dark skin patches removal using subject perception questionnaire.Timepoint: Day 01, Day 30, Day 60;To assess the effectiveness of the test products in terms of change in level of photodamage using Glogau skin age classification.Timepoint: Day 01, Day 30, Day 60;To assess the effectiveness of the test products in terms of change in skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness & sallowness using PGA Scoring as in Griffith’s Scale.Timepoint: Day 01, Day 30, Day 60;To assess the effectiveness of the test products in terms of change in skin pigmentation using skin pigmentation scoring.Timepoint: Day 01, Day 30, Day 60 | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed