A 56-day Clinical Study on Facial Skin Rejuvenation

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06188338
• Other study ID #: C23021036
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 18, 2023
• Est. completion date: February 23, 2024

Study information

• Verified date: December 2023
• Source: Botanee Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: February 23, 2024
• Est. primary completion date: January 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Photoaging
• Skin Manifestations
• Wrinkle

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai China-norm Quality Technical Service Co ,Ltd	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Botanee Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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