Clinical trial

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

ID

Name

W23021025

Description

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.

Trial arms

Trial start

2023-09-24

Estimated PCD

2023-11-30

Trial end

2024-04-30

Status

Active (not recruiting)

Treatment

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.

Arms:

Formulation containing MLYAAT-1002® Composition

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.

Arms:

Blank formulation without MLYAAT-1002® Composition

Size

35

Primary endpoint

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

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

changes in elasticity of facial skin (R2)

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

changes in elasticity of facial skin (F4)

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

changes in facial skin topography (SEsm)

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

changes in facial skin topography (SEw)

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

changes in fine line depth of facial skin

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

changes in wrinkle depth of facial skin

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

changes in skin thickness of facial skin

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

changes in skin density of facial skin

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 35, 'type': 'ESTIMATED'}}

Updated at

2023-12-14

1 organization

1 product

4 indications

Organization

Product

Indication

Indication

Indication

Skin Manifestations

Indication