A 28-day Clinical Study on Facial Skin Rejuvenation

Botanee Group

Status: Completed

Conditions: Skin Manifestations; Skin Laxity; Skin; Wrinkle

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06140628

W23021025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 2 patient groups, including a placebo group

Formulation containing MLYAAT-1002® Composition

Active Comparator group

Description:

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.

Treatment:

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

Blank formulation without MLYAAT-1002® Composition

Placebo Comparator group

Description:

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.

Treatment:

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