A 56-day Clinical Study on Facial Skin Rejuvenation

Botanee Group Co., Ltd.24 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Skin Manifestations Wrinkle Photoaging

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.

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.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai China-norm Quality Technical Service Co ，Ltd

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 0, Day 15, Day 29, Day 57

Data from ClinicalTrials.gov

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Secondary Outcomes

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

measuring hydration of the stratum corneum by Corneometer® MPA580 (Courage\&Khazaka#Germany)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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