A 28-day Clinical Study on Facial Skin Rejuvenation

NCT ID: NCT06140628

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-24
• Study Completion Date: 2024-04-08

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.

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.

Conditions

Wrinkle; Skin Laxity; Skin Manifestations; Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Botanee Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoke Xu, Dr

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Xiaoke BeauCare Clinic

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40041776 (View on PubMed)

Other Identifiers

W23021025

Identifier Type: -

Identifier Source: org_study_id