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NCT Number: NCT06891924

A Clinical Study on Pre-operative Intervention With Products During Aesthetic Medicine

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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Key information

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. changes in the percentage of area in the red zone of facial skin

    Time frame: 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.

  2. Self-assessment of the facial state questionnaire

    Time frame: 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 outcomes

  1. changes in transepidermal water loss (TEWL) of facial skin

    Time frame: 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.

  2. changes in skin stratum corneum water content

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Yihuai Liang

CONTACT

[email protected]

+86 13818831247

Sponsors and collaborators

Lead sponsor

Botanee Group Co., Ltd.

Industry

Registry information

Official study title

Clinical Study on Pre-operative Intervention With Products to Mitigate Skin Discomfort During Aesthetic Medicine

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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