Skin Aging, Skin Condition, Skin Manifestations
Conditions
Brief summary
This clinical trial aims to evaluate whether a 14-day pre-operative application of the test product (containing MLYAAT-1002®, a proprietary anti-aging complex) can mitigate skin discomfort during Fotona 4D laser therapy (Frac3 and Piano modes) by comparing clinical evaluation, skin attributes measurement and subject self-assessment.
Interventions
COMBINATION_PRODUCT14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment
All enrolled subjects will complete a 14-day washout period followed by a 14-day run-in phase prior to Fotona 4D® laser treatment. During the initial washout phase, participants will exclusively use basic skincare products: sunscreen, cleansing foam, and moisturizing emulsion. Then the subjects will apply the formulations containing MLYAAT-1002® of the active comparator to randomly assigned split-face (the treatment side) for the subsequent 14-day period. Following completion of the product application regimen, all participants will undergo a single session of Fotona 4D laser therapy.
COMBINATION_PRODUCT14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment
All enrolled subjects will complete a 14-day washout period followed by a 14-day run-in phase prior to Fotona 4D® laser treatment. During the initial washout phase, participants will exclusively use basic skincare products: sunscreen, cleansing foam, and moisturizing emulsion. Then the subjects will apply the formulations without MLYAAT-1002® of the placebo comparator to randomly assigned split-face (the control side) for the subsequent 14-day period. Following completion of the product application regimen, all participants will undergo a single session of Fotona 4D laser therapy.
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
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* health females aged 35-60; * subjects with rough dark, loose fine lines; * no history of cosmetic allergies; * subjects are willing to use the test serum on split-face for 28 days; * subjects are willing to suffer the Fotona 4D treatment (Frac3 and Piano modes) on the face; * subjects are willing to use the basic skincare products for 28 days, and acceptable for split-face use of the test products or the control product for 14 days; * written informed consent and portrait right consent were obtained from all participants before study entry.
Exclusion criteria
* anyone who is pregnant, nursing an infant, or planning a pregnancy during the study; * subjects with known allergies or sensitivities to the ingredients in any of the study products; * 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, and dermal fillers within one month; * taken/injected anti-allergy medication in the past one month; * participants in other clinical trials at the same time; * any subjects that the investigator considers ineligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in the percentage of area in the red zone of facial skin | Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment) | capturing facial images by VISIA-CR (CANFIELD, America) and analysis the percentage of area in the red zone. |
| Self-assessment of the facial state questionnaire | Baseline (before Fotona 4D treatment), Timm (immediately after Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment) | Subjects rated the burning sensation, picotement, pruritus, dysesthesia, tightness,on a five-point scale: 0=Asymptomatic;1=Very mild;2=mild;3=moderate;4=severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in transepidermal water loss (TEWL) of facial skin | D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment) | measuring the loss of water that passes from inside a body through the epidermis to the surrounding atmosphere by Vapometer. |
| changes in skin stratum corneum water content | D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment) | measuring skin stratum corneum water content by Corneometer CM825 (Courage&Khazaka，Germany). |
Contacts
Primary ContactYihuai Liang
Outcome results
None listed