Effect of Moisturizer on Malaysian Women Facial Skin

Study Overview
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Brief Summary
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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: The effect of Product X on skin hydration of middle-aged women in Malaysia. The effect of Product X on skin elasticity of middle-aged women in Malaysia. The effect of Product X on skin wrinkle of middle-aged women in Malaysia. 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.

Official Title
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The Effect of Product X Moisturizer on Skin Texture of Middle-Aged Women in Malaysia

Conditions
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Healthy

Intervention / Treatment
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* Other: Other: Product X moisturizer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Product X moisturizer<br>Participants will used Product X moisturizer twice daily for 8 weeks | Other: Other: Product X moisturizer<br>* Product X moisturizer containing Hyaluronic Acid and Rosa Damascena Flower Water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skin hydration from baseline and at week 2, 4 and 8 after using Product X | Skin hydration will be assessed using JANUS III skin analyzer | Baseline, week 2, 4 and 8 | 
| Change in skin elasticity from baseline and at week 2, 4 and 8 after using Product X | Skin elasticity will be assessed using JANUS III skin analyzer | Baseline, week 2, 4 and 8 | 
| Change in skin wrinkles from baseline and at week 2, 4 and 8 after using Product X | 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. | Baseline, week 2, 4 and 8 | 
| Adverse effect after using Product X | Based on adverse effect occurrence on participants that occur during study period (8 weeks) | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Middle-aged women, moisturizer