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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation containing MLYAAT-1002® Composition | Active Comparator | Before the Fotana4D Pro® treatment, daily use of the formulation containing MLYAAT-1002® for 14 days: apply one pump of the formulation to the test side of the face twice daily. |
|
| Blank formulation without MLYAAT-1002® Composition | Placebo Comparator | Before the Fotana4D Pro® treatment, daily use of the formulation without MLYAAT-1002® for 14 days: apply one pump of the formulation to the control side of the face twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the percentage of area in the red zone of facial skin | capturing facial images by VISIA-CR (CANFIELD, America) and analysis the percentage of area in the red zone. | Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment) |
| Self-assessment of the facial state questionnaire | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| changes in transepidermal water loss (TEWL) of facial skin | measuring the loss of water that passes from inside a body through the epidermis to the surrounding atmosphere by Vapometer. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yihuai Liang | Contact | +86 13818831247 | liangyihuai@botanee.com |
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|
| 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment | Combination Product | 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. |
|
| changes in skin stratum corneum water content | measuring skin stratum corneum water content by Corneometer CM825 (Courage&Khazaka,Germany). | 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) |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D012877 | Skin Manifestations |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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