Clinical trial

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

Name
C23021036
Description
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.
Trial arms
Trial start
2023-11-18
Estimated PCD
2024-01-28
Trial end
2024-02-23
Treatment
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.
Arms:
Formulation containing MLYAAT-1002® Composition
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.
Arms:
Blank formulation without MLYAAT-1002® Composition
Size
24
Primary endpoint
changes in skin manifestations of photodamage (global score)
Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (tactile skin roughness)
Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (fine lines)
Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (coarse wrinkles)
Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (mottled pigmentation)
Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (erythema)
Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (dull skin)
Day 0, Day 15, Day 29, Day 57
changes in skin manifestations of photodamage (telangiectasia)
Day 0, Day 15, Day 29, Day 57
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}
Updated at
2024-01-03

1 organization

1 product

3 indications

Organization
Botanee Group
Indication
Wrinkle
Indication
Photoaging