A 28-day Clinical Study on Facial Skin Rejuvenation

Study Overview
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Brief Summary
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This clinical trial aims to learn about the efficacy of MLYAAT-1002® (a proprietary anti-aging complex, MLYAAT is short for multi-layer anti-ageing technology ) in female subjects who have newly received the rejuvenation treatment by comparing visual clinical scores, skin attributes measurement and image analysis.

Detailed Description
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The main expectation it aims to answer are: After the 4-week continuous use of the test skin product with MLYAAT-1002®, the skin aging problem is significantly improved compared with it of controlled product. After the single use of the test skin product with MLYAAT-1002®, the instant skin irritation after the Fotona4D Pro® treatment ( a nonablative fractional laser treatment for facial skin rejuvenation) is significantly lower compared with it of controlled product. After the 4-week continuous use of the test skin product with MLYAAT-1002®, the skin TEWL (transepidermal water loss) is significantly recovered from the Fotona4D Pro® treatment compared with it of controlled product. And the skin TEWL after the 4-week continuous use of test product is improved or not significantly worse than it before the Fotona4D Pro® treatment. After the 4-week continuous use of the test skin product with MLYAAT-1002®, no skin irritation symptom is worsen compared to it after the Fotona4D Pro® treatment.

Official Title
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Clinical Study on 28 Day Continuous Improvement of Post-rejuvenation-treatment Skin With Formulations of A Proprietary Anti-aging Complex Composition

Conditions
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Wrinkle, Skin Laxity, Skin Manifestations, Skin

Intervention / Treatment
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* Combination Product: Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002®
* Combination Product: Fotona4D Pro® treatment followed by daily use of formulations without MLYAAT-1002®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: females aged 30-50 no history of cosmetic allergies according to SKIN AGING ATLAS 2(Asian Type), the scores of under-eye wrinkles, pore appearance, forehead wrinkles are all > 2 non-sensitive skin acceptable for split-face use of products for 28 days no using history of antibiotic in the past three months written informed consent and portrait right consent were obtained from all participants before study entry Exclusion Criteria: subjects with known allergies or sensitivities to the ingredients in any of the study products anyone who is pregnant, nursing an infant, or planning a pregnancy during the study any symptoms of facial flushing, erythema, papules, desquamation, or edema as evaluated by a physician prior to initial screening or Fotona4D Pro treatment unhealed skin lesions participated in any other clinical trial within one month received facial skin treatments including but not limited to lasers, chemical peels, dermal fillers within one year taken/injected anti-allergy medication in the past one month other medical reasons that could affect the test results participants in other clinical trials at the same time

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Formulation containing MLYAAT-1002® Composition<br>After the Fotana4D Pro® treatment, daily use of the formulation for 28 days: apply one pump of the formulation to the treated side of the face in the morning and evening, respectively. | Combination Product: Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002®<br>* Each subject will receive a single treatment of the Fotona4D Pro® , followed by the first application of the active comparator on the randomly assigned side of split-face (the treatment side) on the same day, and sequently, will apply the active comparator to this side twice a day for 28 days.<br>|
| Placebo Comparator: Blank formulation without MLYAAT-1002® Composition<br>After the Fotana4D Pro® treatment, daily use of the blank formulation for 28 days: apply one pump of the blank formulation to the control side of the face in the morning and evening, respectively. | Combination Product: Fotona4D Pro® treatment followed by daily use of formulations without MLYAAT-1002®<br>* Each subject will receive a single treatment of the Fotona4D Pro® , followed by the first application of the placebo comparator on the randomly assigned side of split-face (the control side) on the same day, and sequently, will apply the placebo comparator to this side twice a day for 28 dayd.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in individual typology angle (ITA°) of facial skin | capturing facial images by VISIA-7 (CANFIELD, America) and calculating the ITA | Day 0, Day 3, Day 7, Day 14, Day 28 | 
| changes in elasticity of facial skin (R2) | measuring gross elasticity (R2) by Cutometer® MPA580 (Courage&Khazaka, Germany) | Day 0, Day 3, Day 7, Day 14, Day 28 | 
| changes in elasticity of facial skin (F4) | measuring firmness (F4) by Cutometer® MPA580 (Courage&Khazaka, Germany) | Day 0, Day 3, Day 7, Day 14, Day 28 | 
| changes in facial skin topography (SEsm) | evaluating skin smoothness (SEsm) using VisioScan VC20（Courage&Khazaka，Germany） | Day 0, Day 3, Day 7, Day 14, Day 28 | 
| changes in facial skin topography (SEw) | evaluating wrinkles (SEw) using VisioScan VC20（Courage&Khazaka，Germany） | Day 0, Day 3, Day 7, Day 14, Day 28 | 
| changes in fine line depth of facial skin | evaluating peri orbital fine lines by Primos（CANFIELD, America） | Day 0, Day 3, Day 7, Day 14, Day 28 | 
| changes in wrinkle depth of facial skin | evaluating crow's feet wrinkles by Primos（CANFIELD, America） | Day 0, Day 3, Day 7, Day 14, Day 28 | 
| changes in skin thickness of facial skin | measuring skin thickness in µm by Ultrascan UC22（Courage&Khazaka，Germany） | Day 0, Day 3, Day 7, Day 14, Day 28 | 
| changes in skin density of facial skin | measuring skin density (ultrasound density in % ) by Ultrascan UC22（Courage&Khazaka，Germany） | Day 0, Day 3, Day 7, Day 14, Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in transepidermal water loss (TEWL，in g/m2/h) of facial skin | measuring the loss of water that passes from inside a body through the epidermis to the surrounding atmosphere by Tewameter® MPA580 (Courage&Khazaka，Germany) | Day 0, Day 3, Day 7, Day 14, Day 28 |