A 28-day Clinical Study on Facial Skin Rejuvenation

NCT06140628 | Completed

• 1 other identifier: W23021025
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wrinkle; Skin Laxity; Skin Manifestations; Skin

Outcome Measures

Primary Outcomes (9)

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

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

  Day 0, Day 3, Day 7, Day 14, Day 28

• changes in elasticity of facial skin (R2)

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

  Day 0, Day 3, Day 7, Day 14, Day 28

• changes in elasticity of facial skin (F4)

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

  Day 0, Day 3, Day 7, Day 14, Day 28

• changes in facial skin topography (SEsm)

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

  Day 0, Day 3, Day 7, Day 14, Day 28

• changes in facial skin topography (SEw)

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

  Day 0, Day 3, Day 7, Day 14, Day 28

• changes in fine line depth of facial skin

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

  Day 0, Day 3, Day 7, Day 14, Day 28

• changes in wrinkle depth of facial skin

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

  Day 0, Day 3, Day 7, Day 14, Day 28

• changes in skin thickness of facial skin

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

  Day 0, Day 3, Day 7, Day 14, Day 28

• changes in skin density of facial skin

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

  Day 0, Day 3, Day 7, Day 14, Day 28

Secondary Outcomes (1)

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

  Day 0, Day 3, Day 7, Day 14, Day 28

Study Arms (2)

Formulation containing MLYAAT-1002® Composition

ACTIVE COMPARATOR

After the Fotana4D Pro® treatment, daily use of the formulation for 28 days: apply one pump of the formulation to the treated side of the face in the morning and evening, respectively.

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

Blank formulation without MLYAAT-1002® Composition

PLACEBO COMPARATOR

After the Fotana4D Pro® treatment, daily use of the blank formulation for 28 days: apply one pump of the blank formulation to the control side of the face in the morning and evening, respectively.

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

Interventions

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.

Formulation containing MLYAAT-1002® Composition

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.

Blank formulation without MLYAAT-1002® Composition

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Botanee Group Co., Ltd.: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (1)

• Zhang X, Ning M, Lin M, Tang Q, Liang Y, Wang F, Xu X. Continuous Skin Rejuvenation by Combining Nonablative Fractional Laser With Daily Application of a Multibeneficial Composition Formulation: A Blinded Randomized Clinical Trial Study. Health Sci Rep. 2025 Mar 2;8(3):e70423. doi: 10.1002/hsr2.70423. eCollection 2025 Mar.

  PMID: 40041776 DERIVED

MeSH Terms

Conditions

Cutis Laxa; Skin Manifestations

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoke Xu, Dr

  Shenzhen Xiaoke BeauCare Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 20, 2023
• Study Start: September 24, 2023
• Primary Completion: November 7, 2023
• Study Completion: April 8, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

CN (1)