A 28-day Clinical Study on Facial Skin Rejuvenation

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Skin Manifestations; Wrinkle; Skin; Skin Laxity
• Intervention / Treatment: Combination product: Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002®; Combination product: Fotona4D Pro® treatment followed by daily use of formulations without MLYAAT-1002®

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yihuai Liang, Dr; Phone Number: +86 13818831247; Email: liangyihuai@winona.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Shanghai China-norm Quality Technical Service Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Formulation containing MLYAAT-1002® Composition; 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®; 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.
Placebo Comparator: Blank formulation without MLYAAT-1002® Composition; 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®; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in transepidermal water loss (TEWL，in g/m2/h) of facial skin	measuring the loss of water that passes from inside a body through the epidermis to the surrounding atmosphere by Tewameter® MPA580 (Courage&Khazaka，Germany)	Day 0, Day 3, Day 7, Day 14, Day 28

Collaborators and Investigators

• Sponsor: Botanee Group Co., Ltd.
• Investigators: Principal Investigator: Xiaoke Xu, Dr, Shenzhen Xiaoke BeauCare Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 20, 2023

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations
• Other Study ID Numbers: W23021025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No