Skin AgingNCT06891924
A Clinical Study on Pre-operative Intervention With Products During Aesthetic Medicine
A study testing 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment and 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment in people with Skin Aging and Skin Condition, run by Botanee Group Co., Ltd..
Trial summary
This clinical trial aims to evaluate whether a 14-day pre-operative application of the test product (containing MLYAAT-1002®, a proprietary anti-aging complex) can mitigate skin discomfort during Fotona 4D laser therapy (Frac3 and Piano modes) by comparing clinical evaluation, skin attributes measurement and subject… Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Skin Condition, Skin Manifestations
- What is being tested?
- 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment and 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2025to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- health females aged 35-60;
- subjects with rough dark, loose fine lines;
- no history of cosmetic allergies;
- subjects are willing to use the test serum on split-face for 28 days;
- subjects are willing to suffer the Fotona 4D treatment (Frac3 and Piano modes) on the face;
- subjects are willing to use the basic skincare products for 28 days, and acceptable for split-face use of the test products or the control product for 14 days;
- written informed consent and portrait right consent were obtained from all participants before study entry.
Who cannot join
- anyone who is pregnant, nursing an infant, or planning a pregnancy during the study;
- subjects with known allergies or sensitivities to the ingredients in any of the study products;
- 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, and dermal fillers within one month;
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- taken/injected anti-allergy medication in the past one month;
- participants in other clinical trials at the same time;
- any subjects that the investigator considers ineligible.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study on Pre-operative Intervention With Products to Mitigate Skin Discomfort During Aesthetic Medicine
This clinical trial aims to evaluate whether a 14-day pre-operative application of the test product (containing MLYAAT-1002®, a proprietary anti-aging complex) can mitigate skin discomfort during Fotona 4D laser therapy (Frac3 and Piano modes) by comparing clinical evaluation, skin attributes measurement and subject self-assessment.
- Conditions
- Skin Aging, Skin Condition, Skin Manifestations
- Being tested
- 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment, 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment
- Medical subject headings
- Skin Diseases, Skin Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatmentCombination product
All enrolled subjects will complete a 14-day washout period followed by a 14-day run-in phase prior to Fotona 4D® laser treatment. During the initial washout phase, participants will exclusively use basic skincare products: sunscreen, cleansing foam, and moisturizing emulsion. Then the subjects will apply the formulations containing MLYAAT-1002® of the active comparator to randomly assigned split-face (the treatment side) for the subsequent 14-day period. Following completion of the product application regimen, all participants will undergo a single session of Fotona 4D laser therapy.
14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatmentCombination product
All enrolled subjects will complete a 14-day washout period followed by a 14-day run-in phase prior to Fotona 4D® laser treatment. During the initial washout phase, participants will exclusively use basic skincare products: sunscreen, cleansing foam, and moisturizing emulsion. Then the subjects will apply the formulations without MLYAAT-1002® of the placebo comparator to randomly assigned split-face (the control side) for the subsequent 14-day period. Following completion of the product application regimen, all participants will undergo a single session of Fotona 4D laser therapy.
| Study group | Role | What they receive |
|---|---|---|
| Formulation containing MLYAAT-1002® Composition | Active comparator | Before the Fotana4D Pro® treatment, daily use of the formulation containing MLYAAT-1002® for 14 days: apply one pump of the formulation to the test side of the face twice daily. Receives: Combination Product: 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment |
| Blank formulation without MLYAAT-1002® Composition | Placebo comparator | Before the Fotana4D Pro® treatment, daily use of the formulation without MLYAAT-1002® for 14 days: apply one pump of the formulation to the control side of the face twice daily. Receives: Combination Product: 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the percentage of area in the red zone of facial skin
capturing facial images by VISIA-CR (CANFIELD, America) and analysis the percentage of area in the red zone.
Measured: Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
Self-assessment of the facial state questionnaire
Subjects rated the burning sensation, picotement, pruritus, dysesthesia, tightness,on a five-point scale: 0=Asymptomatic;1=Very mild;2=mild;3=moderate;4=severe
Measured: Baseline (before Fotona 4D treatment), Timm (immediately after Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
Secondary outcomes (2)
changes in transepidermal water loss (TEWL) of facial skin
measuring the loss of water that passes from inside a body through the epidermis to the surrounding atmosphere by Vapometer.
Measured: D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
changes in skin stratum corneum water content
measuring skin stratum corneum water content by Corneometer CM825 (Courage\&Khazaka，Germany).
Measured: D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start25 Mar 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Botanee Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891924
- Sponsor's protocol ID
- Botanee-252003
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Pre-operative Intervention With Products to Mitigate Skin Discomfort During Aesthetic Medicine
- ClinicalTrials.gov ID
- NCT06891924
- Acronym / sponsor ID
- Botanee-252003
- Conditions
- Skin Aging, Skin Condition, Skin Manifestations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Botanee Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 24 Mar 2025 (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 evaluate whether a 14-day pre-operative application of the test product (containing MLYAAT-1002®, a proprietary anti-aging complex) can mitigate skin discomfort during Fotona 4D laser therapy (Frac3 and Piano modes) by comparing clinical evaluation, skin attributes measurement and subject self-assessment.
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: 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatmentBefore the Fotana4D Pro® treatment, daily use of the formulation containing MLYAAT-1002® for 14 days: apply one pump of the formulation to the test side of the face twice daily. |
| Blank formulation without MLYAAT-1002® Composition | Placebo comparator | Combination Product: 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatmentBefore the Fotana4D Pro® treatment, daily use of the formulation without MLYAAT-1002® for 14 days: apply one pump of the formulation to the control side of the face twice daily. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- health females aged 35-60;
- subjects with rough dark, loose fine lines;
- no history of cosmetic allergies;
- subjects are willing to use the test serum on split-face for 28 days;
- subjects are willing to suffer the Fotona 4D treatment (Frac3 and Piano modes) on the face;
Key exclusion criteria (9 listed)
- anyone who is pregnant, nursing an infant, or planning a pregnancy during the study;
- subjects with known allergies or sensitivities to the ingredients in any of the study products;
- 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 |
|---|---|---|
| 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatmentAll enrolled subjects will complete a 14-day washout period followed by a 14-day run-in phase prior to Fotona 4D® laser treatment. During the initial washout phase, participants will exclusively use basic skincare products: sunscreen, cleansing foam, and moisturizing emulsion. Then the subjects will apply the formulations containing MLYAAT-1002® of the active comparator to randomly assigned split-face (the treatment side) for the subsequent 14-day period. Following completion of the product application regimen, all participants will undergo a single session of Fotona 4D laser therapy. | Combination product | Formulation containing MLYAAT-1002® Composition |
| 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatmentAll enrolled subjects will complete a 14-day washout period followed by a 14-day run-in phase prior to Fotona 4D® laser treatment. During the initial washout phase, participants will exclusively use basic skincare products: sunscreen, cleansing foam, and moisturizing emulsion. Then the subjects will apply the formulations without MLYAAT-1002® of the placebo comparator to randomly assigned split-face (the control side) for the subsequent 14-day period. Following completion of the product application regimen, all participants will undergo a single session of Fotona 4D laser therapy. | Combination product | Blank formulation without MLYAAT-1002® Composition |
Primary outcome
changes in the percentage of area in the red zone of facial skin
Time frame: Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
capturing facial images by VISIA-CR (CANFIELD, America) and analysis the percentage of area in the red zone.
Self-assessment of the facial state questionnaire
Time frame: Baseline (before Fotona 4D treatment), Timm (immediately after Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
Subjects rated the burning sensation, picotement, pruritus, dysesthesia, tightness,on a five-point scale: 0=Asymptomatic;1=Very mild;2=mild;3=moderate;4=severe
2 secondary outcomes
changes in transepidermal water loss (TEWL) of facial skin
Time frame: D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
changes in skin stratum corneum water content
Time frame: D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment and 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment in people with Skin Aging and Skin Condition, run by Botanee Group Co., Ltd..
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: opening soon, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yihuai Liang (+86 13818831247, liangyihuai@botanee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the percentage of area in the red zone of facial skin (time frame: Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)). The study lists 2 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 1 Apr 2025.