Clinical trial NCT06891924: A Clinical Study on Pre-operative Intervention With Products During Aesthetic Medicine
Official title: Clinical Study on Pre-operative Intervention With Products to Mitigate Skin Discomfort During Aesthetic Medicine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Skin Aging
Skin Condition
Skin Manifestations
Lead sponsor: Botanee Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-24
Enrollment: 33
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: changes in the percentage of area in the red zone of facial skin
timeFrame: Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
measure: Self-assessment of the facial state questionnaire
timeFrame: 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)
Secondary outcomes:
measure: changes in transepidermal water loss (TEWL) of facial skin
timeFrame: 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)
measure: changes in skin stratum corneum water content
timeFrame: 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)
Other outcomes:
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