WrinkleNCT04989361
Soluble Hyaluronic Acid Microneedle VS. Non-ablative Fractional Laser on Infraorbital Wrinkles.
A study testing Soluble Hyaluronic Acid Microneedle and Non-fractional laser in people with Wrinkle, run by Shanghai Dermatology Hospital at 1 site in China.
Trial summary
This study is a prospective half-face controlled study, aiming to evaluate the therapeutic effects and adverse reactions of soluble hyaluronic acid microneedle and non-ablative fractional laser on infraorbital wrinkles and compare them. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Soluble Hyaluronic Acid Microneedle and Non-fractional laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 Jul 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old, Skin Aging Atlas: Volume 2, Asian type infraorbital wrinkles assessment standard score 3 points and above;
- After fully explaining the purpose and content of this clinical trial (including the subjects' compliance, etc.), on the basis of full understanding, voluntarily sign an informed consent to participate in the clinical trial.
Who cannot join
- Those who are known to be allergic to test drugs or related drugs;
- Pregnant or lactating women;
- Received wrinkle treatment (laser, radio frequency, fruit acid, photon, hyaluronic acid filling, etc.) within 6 months before enrollment;
- Those who have other diseases (infection, dermatitis, sunburn, scars, etc.) that may affect the evaluation of the efficacy of the facial treatment area and nearby areas;
- Received anti-inflammatory, glucocorticoid or tretinoin treatment within 1 month before enrollment;
- Participate in any drug clinical trial (as a subject) within 1 month before participating in this trial;
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- Combined with serious diseases, including severe heart disease,cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, etc.;
- Those with scar constitution;
- Subjects with severe physical or mental illness that the investigator believes may affect treatment, evaluation, or poor compliance with the research protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200043
Yutong Yang, 17717095517, dryutong@163.com
About this study
Official title: Clinical Controlled Study and Safety Evaluation of the Therapeutic Effect of Soluble Hyaluronic Acid Microneedle and Non-ablative Fractional Laser on Infraorbital Wrinkles
This study is a prospective half-face controlled study, aiming to evaluate the therapeutic effects and adverse reactions of soluble hyaluronic acid microneedle and non-ablative fractional laser on infraorbital wrinkles and compare them.
Read the detailed description
This study is a prospective half-face controlled study, aiming to evaluate the therapeutic effects and adverse reactions of soluble hyaluronic acid microneedle and non-ablative fractional laser on infraorbital wrinkles and compare them. The therapy is as follows:
- Sign the informed consent form, and then the researchers will include and exclude patients according to the standards;
- The researcher will collect the medical history, evaluate the condition, and determine the treatment plan after grouping by the random table;
- Basic information collection 1) Take VISIA images (3 pictures of the front and sides at 45 degrees and several pictures of the skin lesions), and number and record the feature counts and specific scores of bilateral orbital wrinkles; 2) Measure and record the water content of the patient's periorbital skin;
- Half face controlled treatment:
- Drug preparation Drug: soluble hyaluronic acid microneedles; Equipment: ResurFX; 2) Treatment methods and operating procedures Microneedle side: Apply soluble hyaluronic acid microneedle eye mask to the periorbital area after normal facial cleansing and skin care every night for 20 days . Press and hold for 3 minutes, and then remove it after 1 h. Every 2 days for the next 20 days, and every 3 days for the last 21 days. Follow-up time: every 20 days during the treatment period, and follow-up in the second, fourth, eighth and twelfth week after the treatment.
Non-fractional laser side: The patient received non-ablative fractional laser treatment once. Follow-up time: follow-up visits in the 2nd, 4th, 8th and 12th weeks after the treatment.
- End point of treatment Microneedle side: The soluble hyaluronic acid microcrystalline eye mask was used for 61 days according to the prescribed protocol. After the treatment, the patient entered the follow-up.
Fractional laser side: After one treatment, the patient enters the follow-up.
- Follow-up after treatment Follow-up time: 2 weeks, 4 weeks, 8 weeks, 12 weeks after the end of treatment; Follow-up content: According to the follow-up plan, it is recommended that patients actively come to the hospital for follow-up. The follow-up time starts from the first day after the end of the last treatment. Record the patient's name, gender, age, adverse reactions, etc. in detail, take VISIA photos; test and record the skin moisture content, and fill in the patient satisfaction survey in the 4th week after treatment.
- Conditions
- Wrinkle
- Being tested
- Soluble Hyaluronic Acid Microneedle, Non-fractional laser
- Keywords
- microneedle, non-ablative fractional laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble Hyaluronic Acid MicroneedleProcedure or surgery
The soluble hyaluronic acid microneedle eye mask is a nanometer-sized microneedle made of water-soluble hyaluronic acid, which can directly inject the active ingredients into the dermis, and after being absorbed and dissolved by the skin, it can achieve the purpose of improving the water content and elasticity of the skin.
Non-fractional laserProcedure or surgery
he non-ablative fractional laser use 1565nm fiber laser, which acts on the target base in the dermis-water. The beam penetrates the epidermis and acts on the dermis. Using the principle of focal light and heat, the tissue cells are heated to initiate the repair process, which promotes increased collagen synthesis, thereby Achieve the effect of firming the skin and improving wrinkles.
| Study group | Role | What they receive |
|---|---|---|
| Microneedle side | Experimental | Apply soluble hyaluronic acid microneedle eye mask to the periorbital area after normal facial cleansing and skin care every night for 20 days. Press and hold for 3 minutes, and then remove it after 1 h. Every 2 days for the next 20 days, and every 3 days for the last 21 days. Follow-up time: every 20 days during the treatment period, and follow-up visits in the 2nd, 4th, 8th and 12th weeks after the treatment. Receives: Procedure: Soluble Hyaluronic Acid Microneedle |
| Non-fractional laser side | Active comparator | The patient received non-ablative fractional laser treatment once. Follow-up time: follow-up visits in the 2nd, 4th, 8th and 12th weeks after the treatment. Receives: Procedure: Non-fractional laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rate
The grade of infraorbital wrinkles is assessed by a visual scale. Effective rate is defined as the proportion of patients who get improvement of at least one grade.
Measured: 4 weeks after the treatment
Secondary outcomes (1)
Adverse reaction rate
The adverse reaction is recorded during the study, including erythema, edema, crust, inch and pain. Adverse reaction rate is defined as the proportion of patients who have these reactions respectively.
Measured: Within 12 weeks after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Sep 2021
- Primary completion30 May 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Dermatology Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Wang, Shanghai Dermatology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989361
- Sponsor's protocol ID
- ShanghaiDH
- Status last verified
- Jun 2022
- First submitted
- 18 Jun 2021
- Last updated
- 15 Jun 2022
- 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 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Controlled Study and Safety Evaluation of the Therapeutic Effect of Soluble Hyaluronic Acid Microneedle and Non-ablative Fractional Laser on Infraorbital Wrinkles
- ClinicalTrials.gov ID
- NCT04989361
- Acronym / sponsor ID
- ShanghaiDH
- Conditions
- Wrinkle
- Keywords
- microneedle, non-ablative fractional laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Dermatology HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 4 Aug 2021 (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 study is a prospective half-face controlled study, aiming to evaluate the therapeutic effects and adverse reactions of soluble hyaluronic acid microneedle and non-ablative fractional laser on infraorbital wrinkles and compare them.
Detailed description
This study is a prospective half-face controlled study, aiming to evaluate the therapeutic effects and adverse reactions of soluble hyaluronic acid microneedle and non-ablative fractional laser on infraorbital wrinkles and compare them. The therapy is as follows:
- Sign the informed consent form, and then the researchers will include and exclude patients according to the standards;
- The researcher will collect the medical history, evaluate the condition, and determine the treatment plan after grouping by the random table;
- Basic information collection 1) Take VISIA images (3 pictures of the front and sides at 45 degrees and several pictures of the skin lesions), and number and record the feature counts and specific scores of bilateral orbital wrinkles; 2) Measure and record the water content of the patient's periorbital skin;
- Half face controlled treatment:
- Drug preparation Drug: soluble hyaluronic acid microneedles; Equipment: ResurFX; 2) Treatment methods and operating procedures Microneedle side: Apply soluble hyaluronic acid microneedle eye mask to the periorbital area after normal facial cleansing and skin care every night for 20 days . Press and hold for 3 minutes, and then remove it after 1 h. Every 2 days for the next 20 days, and every 3 days for the last 21 days. Follow-up time: every 20 days during the treatment period, and follow-up in the second, fourth, eighth and twelfth week after the treatment.
Non-fractional laser side: The patient received non-ablative fractional laser treatment once. Follow-up time: follow-up visits in the 2nd, 4th, 8th and 12th weeks after the treatment.
- End point of treatment Microneedle side: The soluble hyaluronic acid microcrystalline eye mask was used for 61 days according to the prescribed protocol. After the treatment, the patient entered the follow-up.
Fractional laser side: After one treatment, the patient enters the follow-up.
- Follow-up after treatment Follow-up time: 2 weeks, 4 weeks, 8 weeks, 12 weeks after the end of treatment; Follow-up content: According to the follow-up plan, it is recommended that patients actively come to the hospital for follow-up. The follow-up time starts from the first day after the end of the last treatment. Record the patient's name, gender, age, adverse reactions, etc. in detail, take VISIA photos; test and record the skin moisture content, and fill in the patient satisfaction survey in the 4th week after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedle side | Experimental | Procedure: Soluble Hyaluronic Acid MicroneedleApply soluble hyaluronic acid microneedle eye mask to the periorbital area after normal facial cleansing and skin care every night for 20 days. Press and hold for 3 minutes, and then remove it after 1 h. Every 2 days for the next 20 days, and every 3 days for the last 21 days. Follow-up time: every 20 days during the treatment period, and follow-up visits in the 2nd, 4th, 8th and 12th weeks after the treatment. |
| Non-fractional laser side | Active comparator | Procedure: Non-fractional laserThe patient received non-ablative fractional laser treatment once. Follow-up time: follow-up visits in the 2nd, 4th, 8th and 12th weeks after the treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years old, Skin Aging Atlas: Volume 2, Asian type infraorbital wrinkles assessment standard score 3 points and above;
- After fully explaining the purpose and content of this clinical trial (including the subjects' compliance, etc.), on the basis of full understanding, voluntarily sign an informed consent to participate in the clinical trial.
Key exclusion criteria (9 listed)
- Those who are known to be allergic to test drugs or related drugs;
- Pregnant or lactating women;
- Received wrinkle treatment (laser, radio frequency, fruit acid, photon, hyaluronic acid filling, etc.) within 6 months before enrollment;
- Those who have other diseases (infection, dermatitis, sunburn, scars, etc.) that may affect the evaluation of the efficacy of the facial treatment area and nearby areas;
- Received anti-inflammatory, glucocorticoid or tretinoin treatment within 1 month before enrollment;
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 |
|---|---|---|
| Soluble Hyaluronic Acid MicroneedleThe soluble hyaluronic acid microneedle eye mask is a nanometer-sized microneedle made of water-soluble hyaluronic acid, which can directly inject the active ingredients into the dermis, and after being absorbed and dissolved by the skin, it can achieve the purpose of improving the water content and elasticity of the skin. | Procedure or surgery | Microneedle side |
| Non-fractional laserhe non-ablative fractional laser use 1565nm fiber laser, which acts on the target base in the dermis-water. The beam penetrates the epidermis and acts on the dermis. Using the principle of focal light and heat, the tissue cells are heated to initiate the repair process, which promotes increased collagen synthesis, thereby Achieve the effect of firming the skin and improving wrinkles. | Procedure or surgery | Non-fractional laser side |
Primary outcome
Effective rate
Time frame: 4 weeks after the treatment
The grade of infraorbital wrinkles is assessed by a visual scale. Effective rate is defined as the proportion of patients who get improvement of at least one grade.
1 secondary outcome
Adverse reaction rate
Time frame: Within 12 weeks after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soluble Hyaluronic Acid Microneedle and Non-fractional laser in people with Wrinkle, run by Shanghai Dermatology Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 15 Jun 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yutong Yang (17717095517, dryutong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective rate (time frame: 4 weeks after the treatment). 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 15 Jun 2022.