Healthy
Conditions
Keywords
Middle-aged women, moisturizer
Brief summary
The goal of this clinical trial is to evaluate the effect of Product X on facial skin of middle-aged women in Malaysia. The main questions it aims to answer are: 1. The effect of Product X on skin hydration of middle-aged women in Malaysia. 2. The effect of Product X on skin elasticity of middle-aged women in Malaysia. 3. The effect of Product X on skin wrinkle of middle-aged women in Malaysia. 4. To observe any adverse effect occurrence with the use of Product X. Participants will used Product X for 8 week and the skin assessment will be carried out at baseline, week 2, 4 and week 8.
Interventions
OTHEROther: Product X moisturizer
Product X moisturizer containing Hyaluronic Acid and Rosa Damascena Flower Water
Sponsors
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Malaysian citizen * Middle-aged woman (40-60 years old)
Exclusion criteria
* Participants taking isotretinoin * Immunocompromised patients or participants with any skin diseases or diseases that may compromised the participants well-being and study outcome. * Participant who undergo any cosmetic procedures such as laser & light treatment for the past three months. * Participant with a history of facial surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin hydration from baseline and at week 2, 4 and 8 after using Product X | Baseline, week 2, 4 and 8 | Skin hydration will be assessed using JANUS III skin analyzer |
| Change in skin elasticity from baseline and at week 2, 4 and 8 after using Product X | Baseline, week 2, 4 and 8 | Skin elasticity will be assessed using JANUS III skin analyzer |
| Change in skin wrinkles from baseline and at week 2, 4 and 8 after using Product X | Baseline, week 2, 4 and 8 | Skin wrinkles will be assessed using JANUS III skin analyzer and Wrinkle Severity Rating Scale (WSRS). For WSRS, dermatologists will evaluate participants' wrinkles based on 5-point photonumeric rating scale that will objectively evaluate the severity of crow's feet at rest (static) and with a smiling expression (dynamic). The scale scores are 0 for no wrinkles, 1 for very fine wrinkles, 2 for fine wrinkles, 3 for moderate wrinkles, and 4 for severe wrinkles. |
| Adverse effect after using Product X | Week 8 | Based on adverse effect occurrence on participants that occur during study period (8 weeks) |
Countries
Malaysia
Outcome results
None listed