WrinkleNCT06140628
A 28-day Clinical Study on Facial Skin Rejuvenation
A study testing Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002® and Fotona4D Pro® treatment followed by daily use of formulations without MLYAAT-1002® in people with Wrinkle and Skin Laxity, 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
- Wrinkle, Skin Laxity, Skin Manifestations
- What is being tested?
- Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002® and Fotona4D Pro® 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
- 37 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2023to 8 Apr 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
- females aged 30-50
- no history of cosmetic allergies
- according to SKIN AGING ATLAS 2(Asian Type), the scores of under-eye wrinkles, pore appearance, forehead wrinkles are all > 2
- non-sensitive skin
- acceptable for split-face use of products for 28 days
- no using history of antibiotic in the past three months
- written informed consent and portrait right consent were obtained from all participants before study entry
Who cannot join
- subjects with known allergies or sensitivities to the ingredients in any of the study products
- anyone who is pregnant, nursing an infant, or planning a pregnancy during the study
- any symptoms of facial flushing, erythema, papules, desquamation, or edema as evaluated by a physician prior to initial screening or Fotona4D Pro treatment
- unhealed skin lesions
- participated in any other clinical trial within one month
- received facial skin treatments including but not limited to lasers, chemical peels, dermal fillers within one year
Show all 9Show fewer
- taken/injected anti-allergy medication in the past one month
- other medical reasons that could affect the test results
- participants in other clinical trials at the same time
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 28 Day Continuous Improvement of Post-rejuvenation-treatment Skin 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 expectation it aims to answer are:
- After the 4-week continuous use of the test skin product with MLYAAT-1002®, the skin aging problem is significantly improved compared with it of controlled product.
- After the single use of the test skin product with MLYAAT-1002®, the instant skin irritation after the Fotona4D Pro® treatment ( a nonablative fractional laser treatment for facial skin rejuvenation) is significantly lower compared with it of controlled product.
- After the 4-week continuous use of the test skin product with MLYAAT-1002®, the skin TEWL (transepidermal water loss) is significantly recovered from the Fotona4D Pro® treatment compared with it of controlled product. And the skin TEWL after the 4-week continuous use of test product is improved or not significantly worse than it before the Fotona4D Pro® treatment.
- After the 4-week continuous use of the test skin product with MLYAAT-1002®, no skin irritation symptom is worsen compared to it after the Fotona4D Pro® treatment.
- Conditions
- Wrinkle, Skin Laxity, Skin Manifestations, Skin
- Being tested
- Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002®, Fotona4D Pro® treatment followed by daily use of formulations without MLYAAT-1002®
- Medical subject headings
- Cutis Laxa, Skin Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002®Combination product
Each subject will receive a single treatment of the Fotona4D Pro® , followed by the first application of the active comparator on the randomly assigned side of split-face (the treatment side) on the same day, and sequently, will apply the active comparator to this side twice a day for 28 days.
Fotona4D Pro® treatment followed by daily use of formulations without MLYAAT-1002®Combination product
Each subject will receive a single treatment of the Fotona4D Pro® , followed by the first application of the placebo comparator on the randomly assigned side of split-face (the control side) on the same day, and sequently, will apply the placebo comparator to this side twice a day for 28 dayd.
| Study group | Role | What they receive |
|---|---|---|
| Formulation containing MLYAAT-1002® Composition | Active comparator | After the Fotana4D Pro® treatment, daily use of the formulation for 28 days: apply one pump of the formulation to the treated side of the face in the morning and evening, respectively. Receives: Combination Product: Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002® |
| Blank formulation without MLYAAT-1002® Composition | Placebo comparator | After the Fotana4D Pro® treatment, daily use of the blank formulation for 28 days: apply one pump of the blank formulation to the control side of the face in the morning and evening, respectively. Receives: Combination Product: Fotona4D Pro® 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 individual typology angle (ITA°) of facial skin
capturing facial images by VISIA-7 (CANFIELD, America) and calculating the ITA
Measured: Day 0, Day 3, Day 7, Day 14, Day 28
changes in elasticity of facial skin (R2)
measuring gross elasticity (R2) by Cutometer® MPA580 (Courage\&Khazaka, Germany)
Measured: Day 0, Day 3, Day 7, Day 14, Day 28
changes in elasticity of facial skin (F4)
measuring firmness (F4) by Cutometer® MPA580 (Courage\&Khazaka, Germany)
Measured: Day 0, Day 3, Day 7, Day 14, Day 28
changes in facial skin topography (SEsm)
evaluating skin smoothness (SEsm) using VisioScan VC20（Courage\&Khazaka，Germany）
Measured: Day 0, Day 3, Day 7, Day 14, Day 28
changes in facial skin topography (SEw)
evaluating wrinkles (SEw) using VisioScan VC20（Courage\&Khazaka，Germany）
Measured: Day 0, Day 3, Day 7, Day 14, Day 28
changes in fine line depth of facial skin
evaluating peri orbital fine lines by Primos（CANFIELD, America）
Measured: Day 0, Day 3, Day 7, Day 14, Day 28
changes in wrinkle depth of facial skin
evaluating crow's feet wrinkles by Primos（CANFIELD, America）
Measured: Day 0, Day 3, Day 7, Day 14, Day 28
changes in skin thickness of facial skin
measuring skin thickness in µm by Ultrascan UC22（Courage\&Khazaka，Germany）
Measured: Day 0, Day 3, Day 7, Day 14, Day 28
changes in skin density of facial skin
measuring skin density (ultrasound density in % ) by Ultrascan UC22（Courage\&Khazaka，Germany）
Measured: Day 0, Day 3, Day 7, Day 14, Day 28
Secondary outcomes (1)
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 7, Day 14, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start24 Sep 2023
- Primary completion7 Nov 2023
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WrinkleStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botanee Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoke Xu, Dr, Principal investigator, Shenzhen Xiaoke BeauCare Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140628
- Sponsor's protocol ID
- W23021025
- Status last verified
- Aug 2024
- First submitted
- 31 Oct 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang X, Ning M, Lin M, Tang Q, Liang Y, Wang F, Xu X. Continuous Skin Rejuvenation by Combining Nonablative Fractional Laser With Daily Application of a Multibeneficial Composition Formulation: A Blinded Randomized Clinical Trial Study. Health Sci Rep. 2025 Mar 2;8(3):e70423. doi: 10.1002/hsr2.70423. eCollection 2025 Mar.
PubMed 40041776
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 28 Day Continuous Improvement of Post-rejuvenation-treatment Skin With Formulations of A Proprietary Anti-aging Complex Composition
- ClinicalTrials.gov ID
- NCT06140628
- Acronym / sponsor ID
- W23021025
- Conditions
- Wrinkle, Skin Laxity, Skin Manifestations, Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Botanee Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2023 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 20 Nov 2023 (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 expectation it aims to answer are:
- After the 4-week continuous use of the test skin product with MLYAAT-1002®, the skin aging problem is significantly improved compared with it of controlled product.
- After the single use of the test skin product with MLYAAT-1002®, the instant skin irritation after the Fotona4D Pro® treatment ( a nonablative fractional laser treatment for facial skin rejuvenation) is significantly lower compared with it of controlled product.
- After the 4-week continuous use of the test skin product with MLYAAT-1002®, the skin TEWL (transepidermal water loss) is significantly recovered from the Fotona4D Pro® treatment compared with it of controlled product. And the skin TEWL after the 4-week continuous use of test product is improved or not significantly worse than it before the Fotona4D Pro® treatment.
- After the 4-week continuous use of the test skin product with MLYAAT-1002®, no skin irritation symptom is worsen compared to it after the Fotona4D Pro® treatment.
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: Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002®After the Fotana4D Pro® treatment, daily use of the formulation for 28 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: Fotona4D Pro® treatment followed by daily use of formulations without MLYAAT-1002®After the Fotana4D Pro® treatment, daily use of the blank formulation for 28 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 (7 listed)
- females aged 30-50
- no history of cosmetic allergies
- according to SKIN AGING ATLAS 2(Asian Type), the scores of under-eye wrinkles, pore appearance, forehead wrinkles are all > 2
- non-sensitive skin
- acceptable for split-face use of products for 28 days
Key exclusion criteria (9 listed)
- subjects with known allergies or sensitivities to the ingredients in any of the study products
- anyone who is pregnant, nursing an infant, or planning a pregnancy during the study
- any symptoms of facial flushing, erythema, papules, desquamation, or edema as evaluated by a physician prior to initial screening or Fotona4D Pro treatment
- unhealed skin lesions
- participated in any other clinical trial within 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 |
|---|---|---|
| Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002®Each subject will receive a single treatment of the Fotona4D Pro® , followed by the first application of the active comparator on the randomly assigned side of split-face (the treatment side) on the same day, and sequently, will apply the active comparator to this side twice a day for 28 days. | Combination product | Formulation containing MLYAAT-1002® Composition |
| Fotona4D Pro® treatment followed by daily use of formulations without MLYAAT-1002®Each subject will receive a single treatment of the Fotona4D Pro® , followed by the first application of the placebo comparator on the randomly assigned side of split-face (the control side) on the same day, and sequently, will apply the placebo comparator to this side twice a day for 28 dayd. | Combination product | Blank formulation without MLYAAT-1002® Composition |
Primary outcome
changes in individual typology angle (ITA°) of facial skin
Time frame: Day 0, Day 3, Day 7, Day 14, Day 28
capturing facial images by VISIA-7 (CANFIELD, America) and calculating the ITA
changes in elasticity of facial skin (R2)
Time frame: Day 0, Day 3, Day 7, Day 14, Day 28
measuring gross elasticity (R2) by Cutometer® MPA580 (Courage\&Khazaka, Germany)
changes in elasticity of facial skin (F4)
Time frame: Day 0, Day 3, Day 7, Day 14, Day 28
measuring firmness (F4) by Cutometer® MPA580 (Courage\&Khazaka, Germany)
changes in facial skin topography (SEsm)
Time frame: Day 0, Day 3, Day 7, Day 14, Day 28
evaluating skin smoothness (SEsm) using VisioScan VC20（Courage\&Khazaka，Germany）
changes in facial skin topography (SEw)
Time frame: Day 0, Day 3, Day 7, Day 14, Day 28
evaluating wrinkles (SEw) using VisioScan VC20（Courage\&Khazaka，Germany）
changes in fine line depth of facial skin
Time frame: Day 0, Day 3, Day 7, Day 14, Day 28
evaluating peri orbital fine lines by Primos（CANFIELD, America）
changes in wrinkle depth of facial skin
Time frame: Day 0, Day 3, Day 7, Day 14, Day 28
evaluating crow's feet wrinkles by Primos（CANFIELD, America）
changes in skin thickness of facial skin
Time frame: Day 0, Day 3, Day 7, Day 14, Day 28
measuring skin thickness in µm by Ultrascan UC22（Courage\&Khazaka，Germany）
changes in skin density of facial skin
Time frame: Day 0, Day 3, Day 7, Day 14, Day 28
measuring skin density (ultrasound density in % ) by Ultrascan UC22（Courage\&Khazaka，Germany）
1 secondary outcome
changes in transepidermal water loss (TEWL，in g/m2/h) of facial skin
Time frame: Day 0, Day 3, Day 7, Day 14, Day 28
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.
- Derived from this study: PubMed 40041776Zhang X, Ning M, Lin M, Tang Q, Liang Y, Wang F, Xu X. Continuous Skin Rejuvenation by Combining Nonablative Fractional Laser With Daily Application of a Multibeneficial Composition Formulation: A Blinded Randomized Clinical Trial Study. Health Sci Rep. 2025 Mar 2;8(3):e70423. doi: 10.1002/hsr2.70423. eCollection 2025 Mar.
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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.
Xiaoke Xu, Dr principal investigator
Shenzhen Xiaoke BeauCare 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 Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002® and Fotona4D Pro® treatment followed by daily use of formulations without MLYAAT-1002® in people with Wrinkle and Skin Laxity, 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 7 inclusion and 9 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 individual typology angle (ITA°) of facial skin (time frame: Day 0, Day 3, Day 7, Day 14, Day 28). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06140628, which also lists 1 linked publication.
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.