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NCT Number: NCT06140628

A 28-day Clinical Study on Facial Skin Rejuvenation

This clinical trial aims to learn about the efficacy of MLYAAT-1002® (a proprietary anti-aging complex, MLYAAT is short for "multi-layer anti-ageing technology" ) in female subjects who have newly received the rejuvenation treatment by comparing visual clinical scores, skin attributes measurement and image analysis.

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Key information

Conditions

Wrinkle Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Skin Diseases Skin Diseases, Genetic Skin Laxity Skin Manifestations Skin and Connective Tissue Diseases

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai China-norm Quality Technical Service Co., Ltd.

Shanghai, Shanghai Municipality, 200072, China

About this study

The main expectation it aims to answer are:

  • After the 4-week continuous use of the test skin product with MLYAAT-1002®, the skin aging problem is significantly improved compared with it of controlled product.
  • After the single use of the test skin product with MLYAAT-1002®, the instant skin irritation after the Fotona4D Pro® treatment ( a nonablative fractional laser treatment for facial skin rejuvenation) is significantly lower compared with it of controlled product.
  • After the 4-week continuous use of the test skin product with MLYAAT-1002®, the skin TEWL (transepidermal water loss) is significantly recovered from the Fotona4D Pro® treatment compared with it of controlled product. And the skin TEWL after the 4-week continuous use of test product is improved or not significantly worse than it before the Fotona4D Pro® treatment.
  • After the 4-week continuous use of the test skin product with MLYAAT-1002®, no skin irritation symptom is worsen compared to it after the Fotona4D Pro® treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • females aged 30-50
  • no history of cosmetic allergies
  • according to SKIN AGING ATLAS 2(Asian Type), the scores of under-eye wrinkles, pore appearance, forehead wrinkles are all > 2
  • non-sensitive skin
  • acceptable for split-face use of products for 28 days
  • no using history of antibiotic in the past three months
  • written informed consent and portrait right consent were obtained from all participants before study entry

Exclusion criteria

  • subjects with known allergies or sensitivities to the ingredients in any of the study products
  • anyone who is pregnant, nursing an infant, or planning a pregnancy during the study
  • 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, dermal fillers within one year
  • taken/injected anti-allergy medication in the past one month
  • other medical reasons that could affect the test results
  • participants in other clinical trials at the same time

Treatment and study plan

Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002®

Combination Product

Each subject will receive a single treatment of the Fotona4D Pro® , followed by the first application of the active comparator on the randomly assigned side of split-face (the treatment side) on the same day, and sequently, will apply the active comparator to this side twice a day for 28 days.

Fotona4D Pro® treatment followed by daily use of formulations without MLYAAT-1002®

Combination Product

Each subject will receive a single treatment of the Fotona4D Pro® , followed by the first application of the placebo comparator on the randomly assigned side of split-face (the control side) on the same day, and sequently, will apply the placebo comparator to this side twice a day for 28 dayd.

Primary outcomes

  1. changes in individual typology angle (ITA°) of facial skin

    Time frame: Day 0, Day 3, Day 7, Day 14, Day 28

    capturing facial images by VISIA-7 (CANFIELD, America) and calculating the ITA

  2. changes in elasticity of facial skin (R2)

    Time frame: Day 0, Day 3, Day 7, Day 14, Day 28

    measuring gross elasticity (R2) by Cutometer® MPA580 (Courage&Khazaka, Germany)

  3. changes in elasticity of facial skin (F4)

    Time frame: Day 0, Day 3, Day 7, Day 14, Day 28

    measuring firmness (F4) by Cutometer® MPA580 (Courage&Khazaka, Germany)

  4. changes in facial skin topography (SEsm)

    Time frame: Day 0, Day 3, Day 7, Day 14, Day 28

    evaluating skin smoothness (SEsm) using VisioScan VC20（Courage&Khazaka，Germany）

  5. changes in facial skin topography (SEw)

    Time frame: Day 0, Day 3, Day 7, Day 14, Day 28

    evaluating wrinkles (SEw) using VisioScan VC20（Courage&Khazaka，Germany）

  6. changes in fine line depth of facial skin

    Time frame: Day 0, Day 3, Day 7, Day 14, Day 28

    evaluating peri orbital fine lines by Primos（CANFIELD, America）

  7. changes in wrinkle depth of facial skin

    Time frame: Day 0, Day 3, Day 7, Day 14, Day 28

    evaluating crow's feet wrinkles by Primos（CANFIELD, America）

  8. changes in skin thickness of facial skin

    Time frame: Day 0, Day 3, Day 7, Day 14, Day 28

    measuring skin thickness in µm by Ultrascan UC22（Courage&Khazaka，Germany）

  9. changes in skin density of facial skin

    Time frame: Day 0, Day 3, Day 7, Day 14, Day 28

    measuring skin density (ultrasound density in % ) by Ultrascan UC22（Courage&Khazaka，Germany）

Secondary outcomes

  1. changes in transepidermal water loss (TEWL，in g/m2/h) of facial skin

    Time frame: Day 0, Day 3, Day 7, Day 14, Day 28

    measuring the loss of water that passes from inside a body through the epidermis to the surrounding atmosphere by Tewameter® MPA580 (Courage&Khazaka，Germany)

Sponsors and collaborators

Lead sponsor

Botanee Group Co., Ltd.

Industry

Registry information

Official study title

Clinical Study on 28 Day Continuous Improvement of Post-rejuvenation-treatment Skin With Formulations of A Proprietary Anti-aging Complex Composition

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Nov 20, 2023
Registry last updated
Aug 16, 2024

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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