A 56-day Clinical Study on Facial Skin Rejuvenation

August 15, 2024 updated by: Botanee Group Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Shanghai China-norm Quality Technical Service Co ，Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
changes in skin manifestations of photodamage (global score)
Time Frame: Day 0, Day 15, Day 29, Day 57
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)
Time Frame: Day 0, Day 15, Day 29, Day 57
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)
Time Frame: Day 0, Day 15, Day 29, Day 57
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)
Time Frame: Day 0, Day 15, Day 29, Day 57
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)
Time Frame: Day 0, Day 15, Day 29, Day 57
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)
Time Frame: Day 0, Day 15, Day 29, Day 57
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)
Time Frame: Day 0, Day 15, Day 29, Day 57
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)
Time Frame: Day 0, Day 15, Day 29, Day 57
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
changes in skin surface hydration(a.u.) of facial skin
Time Frame: Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
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
changes in transepidermal water loss (TEWL#in g/m2/h) of facial skin
Time Frame: Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
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
changes in index of erythema of facial skin
Time Frame: Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
measuring erythema by Mexameter MX18(Courage&Khazaka, Germany)
Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
changes in index of melanin of facial skin
Time Frame: Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
measuring melanin by Mexameter MX18(Courage&Khazaka, Germany)
Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
changes in individual typology angle (ITA°) of facial skin
Time Frame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
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
changes in the percentage of facial skin pore area
Time Frame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
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
changes in the characteristics of facial wrinkles （depth)
Time Frame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
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
changes in the characteristics of facial wrinkles
Time Frame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
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
changes in the characteristics of crow's feet
Time Frame: Day 0, Day 29, Day 57
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
safety and tolerability
Time Frame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
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
self-assessment by participants
Time Frame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Botanee Group Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yan Shuxian, Dr, Shanghai Yaokang Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C23021036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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