Skin, Skin Laxity, Skin Manifestations, Wrinkle
Conditions
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.
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.
Interventions
COMBINATION_PRODUCTFotona4D 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.
COMBINATION_PRODUCTFotona4D 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.
Sponsors
Botanee Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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） |
| 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） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Outcome results
None listed