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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.
The main expectation it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation containing MLYAAT-1002® Composition | Active Comparator | 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. |
|
| Blank formulation without MLYAAT-1002® Composition | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002® | Combination Product | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoke Xu, Dr | Shenzhen Xiaoke BeauCare Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai China-norm Quality Technical Service Co., Ltd. | Shanghai | Shanghai Municipality | 200072 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40041776 | Derived | Zhang X, Ning M, Lin M, Tang Q, Liang Y, Wang F, Xu X. Continuous Skin Rejuvenation by Combining Nonablative Fractional Laser With Daily Application of a Multibeneficial Composition Formulation: A Blinded Randomized Clinical Trial Study. Health Sci Rep. 2025 Mar 2;8(3):e70423. doi: 10.1002/hsr2.70423. eCollection 2025 Mar. |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D012877 | Skin Manifestations |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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|
| Fotona4D Pro® treatment followed by daily use of formulations without MLYAAT-1002® | Combination Product | 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. |
|
| 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 |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |