A 56-day Clinical Study on Facial Skin Rejuvenation

NCT ID: NCT06188338

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-18
• Study Completion Date: 2024-08-15

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.

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.

Conditions

Skin Manifestations; Wrinkle; Photoaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Botanee Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Shuxian, Dr

Role: PRINCIPAL_INVESTIGATOR

Shanghai Yaokang Clinic

Locations

Shanghai China-norm Quality Technical Service Co ，Ltd

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

C23021036

Identifier Type: -

Identifier Source: org_study_id