A 28-day Clinical Study on Facial Skin Rejuvenation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Formulation containing MLYAAT-1002® Composition 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®
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.
|
| Placebo Comparator: Blank formulation without MLYAAT-1002® Composition 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®
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.
|
Outcome Measures
Primary Outcome Measures
- changes in individual typology angle (ITA°) of facial skin [Day 0, Day 3, Day 7, Day 14, Day 28]
capturing facial images by VISIA-7 (CANFIELD, America) and calculating the ITA
- changes in elasticity of facial skin (R2) [Day 0, Day 3, Day 7, Day 14, Day 28]
measuring gross elasticity (R2) by Cutometer® MPA580 (Courage&Khazaka, Germany)
- changes in elasticity of facial skin (F4) [Day 0, Day 3, Day 7, Day 14, Day 28]
measuring firmness (F4) by Cutometer® MPA580 (Courage&Khazaka, Germany)
- changes in facial skin topography (SEsm) [Day 0, Day 3, Day 7, Day 14, Day 28]
evaluating skin smoothness (SEsm) using VisioScan VC20（Courage&Khazaka，Germany）
- changes in facial skin topography (SEw) [Day 0, Day 3, Day 7, Day 14, Day 28]
evaluating wrinkles (SEw) using VisioScan VC20（Courage&Khazaka，Germany）
- changes in fine line depth of facial skin [Day 0, Day 3, Day 7, Day 14, Day 28]
evaluating peri orbital fine lines by Primos（CANFIELD, America）
- changes in wrinkle depth of facial skin [Day 0, Day 3, Day 7, Day 14, Day 28]
evaluating crow's feet wrinkles by Primos（CANFIELD, America）
- changes in skin thickness of facial skin [Day 0, Day 3, Day 7, Day 14, Day 28]
measuring skin thickness in µm by Ultrascan UC22（Courage&Khazaka，Germany）
- changes in skin density of facial skin [Day 0, Day 3, Day 7, Day 14, Day 28]
measuring skin density (ultrasound density in % ) by Ultrascan UC22（Courage&Khazaka，Germany）
Secondary Outcome Measures
- changes in transepidermal water loss (TEWL，in g/m2/h) of facial skin [Day 0, Day 3, Day 7, Day 14, Day 28]
measuring the loss of water that passes from inside a body through the epidermis to the surrounding atmosphere by Tewameter® MPA580 (Courage&Khazaka，Germany)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai China-norm Quality Technical Service Co., Ltd. | Shanghai | Shanghai | China | 200072 |
Sponsors and Collaborators
- Botanee Group Co., Ltd.
Investigators
- Principal Investigator: Xiaoke Xu, Dr, Shenzhen Xiaoke BeauCare Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- W23021025