Clinical trial NCT06140628: A 28-day Clinical Study on Facial Skin Rejuvenation
Official title: Clinical Study on 28 Day Continuous Improvement of Post-rejuvenation-treatment Skin With Formulations of A Proprietary Anti-aging Complex Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Skin Laxity
Skin Manifestations
Skin
Lead sponsor: Botanee Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-20
Enrollment: 37
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: changes in individual typology angle (ITA°) of facial skin
timeFrame: Day 0, Day 3, Day 7, Day 14, Day 28
measure: changes in elasticity of facial skin (R2)
timeFrame: Day 0, Day 3, Day 7, Day 14, Day 28
measure: changes in elasticity of facial skin (F4)
timeFrame: Day 0, Day 3, Day 7, Day 14, Day 28
measure: changes in facial skin topography (SEsm)
timeFrame: Day 0, Day 3, Day 7, Day 14, Day 28
measure: changes in facial skin topography (SEw)
timeFrame: Day 0, Day 3, Day 7, Day 14, Day 28
measure: changes in fine line depth of facial skin
timeFrame: Day 0, Day 3, Day 7, Day 14, Day 28
measure: changes in wrinkle depth of facial skin
timeFrame: Day 0, Day 3, Day 7, Day 14, Day 28
measure: changes in skin thickness of facial skin
timeFrame: Day 0, Day 3, Day 7, Day 14, Day 28
measure: changes in skin density of facial skin
timeFrame: Day 0, Day 3, Day 7, Day 14, Day 28
Secondary outcomes:
measure: changes in transepidermal water loss (TEWL，in g/m2/h) of facial skin
timeFrame: Day 0, Day 3, Day 7, Day 14, Day 28
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai China-norm Quality Technical Service Co., Ltd.
state: Shanghai
Study officials:
affiliation: Shenzhen Xiaoke BeauCare Clinic
name: Xiaoke Xu, Dr
role: PRINCIPAL_INVESTIGATOR
References: