Clinical trial NCT06188338: A 56-day Clinical Study on Facial Skin Rejuvenation
Official title: Clinical Study on 56-Day Continuous Improvement of 1064nm Fractional Picosecond Laser Treatment With Formulations of A Proprietary Anti-aging Complex Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Manifestations
Wrinkle
Photoaging
Lead sponsor: Botanee Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-03
Enrollment: 24
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 expectations are:

* After the 8-week continuous use of the test formulations with MLYAAT-1002® on one split-face side, the clinical manifestations and scores of photoaging improve compared to those of the control side using the placebo formulations.
* After the 8-week continuous use of the test formulations with MLYAAT-1002®, indicators of skin tone, individual type angle (ITA), CIELAB color space, pores and wrinkles improve compared to those of the control side using the placebo formulations.

Eligibility criteria: Inclusion Criteria:

* self-reported facial aging problems such as roughness, fine lines, and dull skin
* no symptoms of itching, tingling, or burning on the face
* no symptoms of facial flushing, erythema, papules, desquamation, or spot haemorrhage as evaluated by a dermatologist
* photodamage scores above 2 (evaluated by a dermatologist)
* compliance with split-face use of the assigned formulations for 56 days
* no antibiotics remedy in the past three months
* regular use of sunscreen products at least five times a week
* no plans to leave Shanghai during the period of the trial
* compliance with no use of any cosmetics that may bias the study results during the period of the trial
* written informed consent and portrait right consent were obtained from all participants before study entry

Exclusion Criteria:

* female subjects who are pregnant, lactating or planning to become pregnant
* history of alcoholism
* history of allergies
* subjects who have received medical rejuvenation treatment within the past one year
* being a participant in any other clinical trial within the past one month
* subjects who are suffering from facial skin diseases (melasma, acne, and herpes simplex, etc.)
* subjects with scar constitution or that predispose to Koebner's phenomenon (such as vitiligo and lichen planus, etc.)
* subjects who had skin diseases (such as psoriasis, eczema, and skin cancer, etc.)
* taken/injected anti-allergy medication in the past one month
* subjects who had a high fever in the past 2 weeks
* received anticancer chemotherapy or immunotherapy in the past 6 months
* anyone that the investigator thinks of not eligible.

Primary outcomes:
measure: changes in skin manifestations of photodamage (global score)
timeFrame: Day 0, Day 15, Day 29, Day 57
measure: changes in skin manifestations of photodamage (tactile skin roughness)
timeFrame: Day 0, Day 15, Day 29, Day 57
measure: changes in skin manifestations of photodamage (fine lines)
timeFrame: Day 0, Day 15, Day 29, Day 57
measure: changes in skin manifestations of photodamage (coarse wrinkles)
timeFrame: Day 0, Day 15, Day 29, Day 57
measure: changes in skin manifestations of photodamage (mottled pigmentation)
timeFrame: Day 0, Day 15, Day 29, Day 57
measure: changes in skin manifestations of photodamage (erythema)
timeFrame: Day 0, Day 15, Day 29, Day 57
measure: changes in skin manifestations of photodamage (dull skin)
timeFrame: Day 0, Day 15, Day 29, Day 57
measure: changes in skin manifestations of photodamage (telangiectasia)
timeFrame: Day 0, Day 15, Day 29, Day 57
Secondary outcomes:
measure: changes in skin surface hydration(a.u.) of facial skin
timeFrame: Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
measure: changes in transepidermal water loss (TEWL#in g/m2/h) of facial skin
timeFrame: Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
measure: changes in index of erythema of facial skin
timeFrame: Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
measure: changes in index of melanin of facial skin
timeFrame: Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
measure: changes in individual typology angle (ITA°) of facial skin
timeFrame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
measure: changes in the percentage of facial skin pore area
timeFrame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
measure: changes in the characteristics of facial wrinkles （depth)
timeFrame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
measure: changes in the characteristics of facial wrinkles
timeFrame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
measure: changes in the characteristics of crow's feet
timeFrame: Day 0, Day 29, Day 57
measure: safety and tolerability
timeFrame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
measure: self-assessment by participants
timeFrame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai China-norm Quality Technical Service Co ，Ltd
state: Shanghai
Study officials:
affiliation: Shanghai Yaokang Clinic
name: Yan Shuxian, Dr
role: PRINCIPAL_INVESTIGATOR
References: