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Not yet recruiting NCT06891924

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

No phase Interventional Skin Aging Skin Condition Skin Manifestations

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment, 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment.
Who it may be relevant to
Registry conditions: Skin Aging, Skin Condition, Skin Manifestations. Basic parameters: 35 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 product 14-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 appl
  • Combination product 14-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 applicat

Primary outcome measures

  • 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)]
  • 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)]
Secondary outcome measures (2)
  • 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)]
  • 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06891924 · Botanee-252003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗