Skin ManifestationsNCT06188338
A 56-day Clinical Study on Facial Skin Rejuvenation
A study testing Fractional picosecond laser treatment followed by daily use of formulations containing MLYAAT-1002®. and Fractional picosecond laser treatment followed by daily use of formulations without MLYAAT-1002® in people with Skin Manifestations and Wrinkle, run by Botanee Group Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Manifestations, Wrinkle, Photoaging
- What is being tested?
- Fractional picosecond laser treatment followed by daily use of formulations containing MLYAAT-1002®. and Fractional picosecond laser treatment followed by daily use of formulations without MLYAAT-1002®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2023to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai China-norm Quality Technical Service Co ，Ltd
Shanghai, Shanghai Municipality, 200072
About this study
Official title: 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.
Read the 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
- Being tested
- Fractional picosecond laser treatment followed by daily use of formulations containing MLYAAT-1002®., Fractional picosecond laser treatment followed by daily use of formulations without MLYAAT-1002®
- Medical subject headings
- Skin Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Formulation containing MLYAAT-1002® Composition | Active comparator | 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. Receives: Combination Product: Fractional picosecond laser treatment followed by daily use of formulations containing MLYAAT-1002®. |
| Blank formulation without MLYAAT-1002® Composition | Placebo comparator | 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. Receives: Combination Product: Fractional picosecond laser treatment followed by daily use of formulations without MLYAAT-1002® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0, Day 15, Day 29, Day 57
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.
Measured: Day 0, Day 15, Day 29, Day 57
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.
Measured: Day 0, Day 15, Day 29, Day 57
Secondary outcomes (11)
changes in skin surface hydration(a.u.) of facial skin
measuring hydration of the stratum corneum by Corneometer® MPA580 (Courage\&Khazaka#Germany)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
changes in the percentage of facial skin pore area
capturing facial images by VISIA-7 (CANFIELD, America) and calculating the percentage of pore area
Measured: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
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
Measured: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
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
Measured: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
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
Measured: Day 0, Day 29, Day 57
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 .
Measured: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
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.
Measured: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start18 Nov 2023
- Primary completion27 Jan 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ManifestationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botanee Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Shuxian, Dr, Principal investigator, Shanghai Yaokang Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188338
- Sponsor's protocol ID
- C23021036
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on 56-Day Continuous Improvement of 1064nm Fractional Picosecond Laser Treatment With Formulations of A Proprietary Anti-aging Complex Composition
- ClinicalTrials.gov ID
- NCT06188338
- Acronym / sponsor ID
- C23021036
- Conditions
- Skin Manifestations, Wrinkle, Photoaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Botanee Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2023 (actual)
- Primary completion
- 27 Jan 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulation containing MLYAAT-1002® Composition | Active comparator | Combination Product: Fractional picosecond laser treatment followed by daily use of formulations containing MLYAAT-1002®.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. |
| Blank formulation without MLYAAT-1002® Composition | Placebo comparator | Combination Product: Fractional picosecond laser treatment followed by daily use of formulations without MLYAAT-1002®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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | 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. | Combination product | Blank formulation without MLYAAT-1002® Composition |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
11 secondary outcomes
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
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
changes in index of erythema of facial skin
Time frame: 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
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
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
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
changes in the characteristics of facial wrinkles
Time frame: 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
safety and tolerability
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Shuxian, Dr principal investigator
Shanghai Yaokang Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional picosecond laser treatment followed by daily use of formulations containing MLYAAT-1002®. and Fractional picosecond laser treatment followed by daily use of formulations without MLYAAT-1002® in people with Skin Manifestations and Wrinkle, run by Botanee Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in skin manifestations of photodamage (global score) (time frame: Day 0, Day 15, Day 29, Day 57). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.