A 56-day Clinical Study on Facial Skin Rejuvenation

NCT06188338 | Completed

• 1 other identifier: C23021036
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Manifestations; Wrinkle; Photoaging

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (11)

• changes in skin surface hydration(a.u.) of facial skin

  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

  Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

• changes in index of erythema of facial skin

  Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

• changes in index of melanin of facial skin

  Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

• changes in individual typology angle (ITA°) of facial skin

  Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

Study Arms (2)

Formulation containing MLYAAT-1002® Composition

ACTIVE COMPARATOR

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®.

Blank formulation without MLYAAT-1002® Composition

PLACEBO COMPARATOR

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®

Interventions

Fractional picosecond laser treatment followed by daily use of formulations containing MLYAAT-1002®. COMBINATION_PRODUCT

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.

Formulation containing MLYAAT-1002® Composition

Fractional picosecond laser treatment followed by daily use of formulations without MLYAAT-1002® COMBINATION_PRODUCT

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.

Blank formulation without MLYAAT-1002® Composition

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Botanee Group Co., Ltd.: lead

Study Sites (1)

Shanghai China-norm Quality Technical Service Co ，Ltd

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Skin Manifestations

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan Shuxian, Dr

  Shanghai Yaokang Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 3, 2024
• Study Start: November 18, 2023
• Primary Completion: January 27, 2024
• Study Completion: August 15, 2024
• Last Updated: August 16, 2024

Record last verified: 2023-12

Locations

CN (1)