A 28-day Clinical Study on Facial Skin Rejuvenation

Botanee Group Co., Ltd.37 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Wrinkle Skin Laxity Skin Manifestations Skin

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.

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.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Shanghai, Shanghai Municipality, China