None listed
Conditions
Interventions
Intervention1: INDUS1510: Approximately 1 gm of test product on the entire face applying around the region close to the eyes and mouth and will be massaged gently for 30 seconds. Application of produc
Sponsors
Indus Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: a) Voluntary women from 35 years to 55 years of age. b) Participants with mild (Fine wrinkles and less number of lines) to moderate (Fine to moderate depth wrinkles with moderate number of lines) wrinkles in crowâ??s feet area c) Participants with photo type III (Light brown, sometimes burn, Difficult to tan) and IV (Moderate brown, rare burn, tan with ease) as per the Fitzpatrick scale. d) Having healthy skin on face. e) Willingness to discontinue the use of other cosmetic products on face during the course of the study. f) Accepting not to use products with the same end benefit during the entire study duration. g) Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. h) Having signed a Consent Form, after being informed orally and in writing of all information concerning the study procedures and study objectives. i) Willingness to avoid intense UV exposure as far as possible for the entire study duration
Exclusion criteria
Exclusion criteria: a) Pregnant women by UPT / lactating women / women planning pregnancy. b) Any skin disease on face c) Any cutaneous conditions on test site (scars, moles, papules etc). d) Hypersensitivity, allergy antecedent (to any cosmetic product, raw material). e) Chronic illness which may influence the study results. f) Any clinically significant systemic or cutaneous disease, which may interfere with study procedures. g) For whom the Investigator considers that he/she will not be compliant with study procedures. h) Participants on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month). i) Subject in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measuring depth of wrinkles (Rt) and surface roughness (Ra) around crowâ??s feet areaTimepoint: Baseline,day 30 and day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatologists and subjective assessment - Clinical evaluation for in use skin tolerance of the test productTimepoint: Day 30 and day 60;Evaluating collagen distributionTimepoint: Baseline,day 30 and day 60;ITA values for Skin Luminescence and Skin Color.Timepoint: Baseline,day 30 and day 60;Measuring deep skin fluid changesTimepoint: Baseline,day 30 and day 60;Measuring skin firmness and elasticityTimepoint: Baseline,day 30 and day 60;Measuring skin glossTimepoint: Baseline,day 30 and day 60;Measuring skin hydrationTimepoint: Baseline,day 30 and day 60;Measuring Trans-Epidermal Water LossTimepoint: Baseline,day 30 and day 60;Subjective Self-assessment-Evaluation questionnaire for efficacyTimepoint: Day 30 and day 60 | — |
Countries
India
Contacts
Public ContactMs Pallavi Deshpande
Indus Biotech Pvt. Ltd., Pune
Outcome results
None listed