A 56-day Clinical Study on Facial Skin Rejuvenation

Clinical Study on 56-Day Continuous Improvement of 1064nm Fractional Picosecond Laser Treatment With Formulations of A Proprietary Anti-aging Complex Composition

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Skin Manifestations; Wrinkle; Photoaging
• Intervention / Treatment: Combination product: Fractional picosecond laser treatment followed by daily use of formulations containing MLYAAT-1002®.; Combination product: Fractional picosecond laser treatment followed by daily use of formulations without MLYAAT-1002®

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Shanghai China-norm Quality Technical Service Co ，Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Formulation containing MLYAAT-1002® Composition; After the 1064nm fractional picosecond laser treatment, daily use of the formulation for 56 days: apply one pump of the formulation to the treated side of the face in the morning and evening, respectively.	Combination product: Fractional picosecond laser treatment followed by daily use of formulations containing MLYAAT-1002®.; Each subject will receive a single treatment of the fractional picosecond laser, followed by the first application of the active comparator on the randomly assigned side of the split-face (the treatment side) on the same day, and sequently, will apply the active comparator to this side twice a day for 56 days.
Placebo Comparator: Blank formulation without MLYAAT-1002® Composition; After the 1064nm fractional picosecond laser treatment, daily use of the blank formulation for 56 days: apply one pump of the blank formulation to the control side of the face in the morning and evening, respectively.	Combination product: Fractional picosecond laser treatment followed by daily use of formulations without MLYAAT-1002®; Each subject will receive a single treatment of the fractional picosecond laser, followed by the first application of the placebo comparator on the randomly assigned side of the split-face (the control side) on the same day, and sequently, will apply the placebo comparator to this side twice a day for 56 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in skin manifestations of photodamage (global score)	Scoring by two independent dermatologists, a global score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.	Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (tactile skin roughness)	Scoring by two independent dermatologists, a roughness score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.	Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (fine lines)	Scoring by two independent dermatologists, a fine-line score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.	Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (coarse wrinkles)	Scoring by two independent dermatologists, a coarse-wrinkle score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.	Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (mottled pigmentation)	Scoring by two independent dermatologists, a pigmentation score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.	Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (erythema)	Scoring by two independent dermatologists, an erythema score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.	Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (dull skin)	Scoring by two independent dermatologists, a dull-skin score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.	Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (telangiectasia)	Scoring by two independent dermatologists, a telangiectasia score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.	Day 0, Day 15, Day 29, Day 57

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in skin surface hydration(a.u.) of facial skin	measuring hydration of the stratum corneum by Corneometer® MPA580 (Courage&Khazaka#Germany)	Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
changes in transepidermal water loss (TEWL#in g/m2/h) of facial skin	measuring the loss of water that passes from inside a body through the epidermis to the surrounding atmosphere by Tewameter® MPA580 (Courage&Khazaka#Germany)	Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
changes in index of erythema of facial skin	measuring erythema by Mexameter MX18(Courage&Khazaka, Germany)	Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
changes in index of melanin of facial skin	measuring melanin by Mexameter MX18(Courage&Khazaka, Germany)	Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
changes in individual typology angle (ITA°) of facial skin	capturing facial images by VISIA-7 (CANFIELD, America) and calculating the ITA	Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
changes in the percentage of facial skin pore area	capturing facial images by VISIA-7 (CANFIELD, America) and calculating the percentage of pore area	Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
changes in the characteristics of facial wrinkles （depth)	capturing facial images by VISIA-7 (CANFIELD, America), and recording the depth of wrinkles at the specific face region	Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
changes in the characteristics of facial wrinkles	capturing facial images by VISIA-7 (CANFIELD, America), and recording the area of wrinkles at the specific face region	Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
changes in the characteristics of crow's feet	capturing facial images by Primos (CANFIELD, America) and calculating the area of crow's feet at the specific face region	Day 0, Day 29, Day 57
safety and tolerability	Any adverse effects (e.g., erythema, flush, stinging, pruritus, and spot hemorrhage, desquamation) on both sides of face will be recorded at each visit by two independent dermatologists. The severity of the observed effect will be scored on a 5-point scale (0-4) , i.e., higher scores meaning a more severe level .	Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
self-assessment by participants	All the particpants will be asked to report any discomfort (e.g., stinging, pruritus, burning sensation) in their faces at each visit. The severity of the reported discomfort will be scored on a 5-point scale (0-4) , i.e., higher scores meaning a more severe level.	Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

Collaborators and Investigators

• Sponsor: Botanee Group Co., Ltd.
• Investigators: Principal Investigator: Yan Shuxian, Dr, Shanghai Yaokang Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2023
• Primary Completion (Estimated): January 28, 2024
• Study Completion (Estimated): February 23, 2024

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Estimated): January 3, 2024

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations
• Other Study ID Numbers: C23021036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No