Facial wrinkles
Conditions
Interventions
Study setting: Recruitment of subjects would be from University of Colombo. The measurement of skin parameters will be conducted in a medical clinic in Battaramulla under the supervision of a specia
Sponsors
Link Natural Products (Pvt) Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male and female subjects who are in the age group 35 (minimum age) – 65 (maximum age) years with modified Fitzpatrick wrinkle scale class 1 to 3. Same wrinkles grading should be present in both left and right sides of face (corners of the eyes, forehead, nasolabial fold and around mouth /marionette lines).
Exclusion criteria
Exclusion criteria: 1. Subjects who had surgery on the measured area of the face. 2. Subjects already on medication for skin improvement (supplements/oral marine collagen). 3. Subjects with any systemic disorder with skin manifestations or facial dermatoses or acne that would confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis or cancer etc.). 4. Female subjects who are pregnant (positive urine pregnancy test) or lactating or who are planning to become pregnant or get married during the study period. 5. Subjects who have started, stopped or changed hormonal treatment (e.g., contraception, thyroid etc.) in the 3 months prior the study commencement. 6. Subjects with hypersensitivity to any cosmetic products used previously. 7. Subjects who have received rejuvenating treatment in the past 3 months. 8. Subjects who are having scleroderma and connective tissue diseases . 9. Subjects who are on recent physician directed facial rejuvenation treatments botox/peeling/laser/dermal fillers /microneedling etc…)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Determination of change in wrinkles overall size, average depth, average width, maximum depth and indentation index assessed by using the Antera 3 D camera. [Baseline (prior to the commencement of intervention), 4 th week, 8 th week and 12 th week after the baseline ] 2. Determination of change in skin texture as a roughness value assessed using the Antera 3 D camera. [Baseline (prior to the commencement of intervention), 4 th week, 8 th week and 12 th week after the baseline] 3. Determination of change in skin elasticity assessed using the cutometer dual MPA 580. [Baseline (prior to the commencement of intervention), 4 th weeks, 8 th weeks and 12 th weeks after the baseline ] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Determination of safety of Link Anti wrinkle cream by determining the percentage of persons who experienced adverse events/ adverse reactions. [The outcome will be monitored through out the project ] 2. Sensory evaluation of the product as assessed by a questionnaire developed using American Society for Testing and Materials (E1490-19) - Standard Guide for Two Sensory Descriptive Approaches for Skin Creams and lotions, 2020: Consumer Behavior Descriptive Analysis. The organoleptic properties such as smell/aroma, appearance and texture (feeling of the cream applying on the skin for the stickiness, easy to apply) of the product are ranked for the given scale. Also the after effect of applying the cream and overall acceptability of the product are ranked in the given scale [The outcome will be monitored in 4 th week, 8 th week and 12 th week ] | — |
Countries
Sri Lanka
Contacts
Public ContactProf. Jennifer Perera
Principal Investigator
Outcome results
None listed