Infraorbital HollowingNCT06394076
A Study to Evaluate the Safety and Effectiveness of Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population
A study testing Cross-linked sodium hyaluronate gel for injection containing lidocaine in people with Infraorbital Hollowing, run by Sinclair Pharmaceuticals Limited at 1 site in China.
Trial summary
A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of MAILI PRECISE With Lidocaine Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infraorbital Hollowing
- What is being tested?
- Cross-linked sodium hyaluronate gel for injection containing lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2023to 30 Apr 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or above (subject to the time of signing the informed consent form) , gender is not limited;
- According to Allergan Infraorbital Rim Scale (AIHS), the subjects were judged by blinded evaluator as having "moderate" or "severe" infraorbital rim hallowing (grade 2-3) in each eye, and both eyes must meet the requirements but do not need to have the same score;
- The injection investigator believes that the hallowing of the infraorbital rim area of the subject can be corrected to grade 0 or grade 1;
- Able and willing to follow the investigator's guidance, following the treatment restrictions in this protocol, and completing all the visits of this trial as required ;
- Able to complete the self-assessment of effectiveness without the use of glasses (contact lenses are accepted if the subject wear contact lenses for all the follow-up visits);
- Volunteer to participate in this clinical trial and sign the Informed Consent Form.
Who cannot join
- Atrophy in the infraorbital area;
- Previous trauma to the infraorbital area, or residual defects, deformities, or scarring in the periorbital or cheek area before screening;
- The investigator considers that there is a large lower eyelid fat pad that will affect the treatment outcome;
- The front most part of the eyeball protrudes forward more than the front most part of the cheek;
- Hyperpigmentation in the infraorbital area (excluding dark circles which are not caused by hyperpigmentation).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Hongsen Bi, hongsenbi@sina.com
About this study
Official title: A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of MAILI PRECISE With Lidocaine Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population
A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of MAILI PRECISE With Lidocaine Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population
- Conditions
- Infraorbital Hollowing
- Being tested
- Cross-linked sodium hyaluronate gel for injection containing lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-linked sodium hyaluronate gel for injection containing lidocaineDevice
Cross-linked sodium hyaluronate gel for injection containing lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Cross-linked sodium hyaluronate gel for injection containing lidocaine | Experimental | Cross-linked sodium hyaluronate gel for injection containing lidocaine Receives: Device: Cross-linked sodium hyaluronate gel for injection containing lidocaine |
| No treatment control | No intervention | No treatment control |
What is being measured
The primary outcome is the main question the study is designed to answer.
At 3 months after the last treatment in the experimental group, and 3 months after the randomization of the control group, blinded evaluators will use AIHS to evaluate the improvement rate of the infraorbital hallowing.
Measured: 3 month
Secondary outcomes (2)
At one month after the last injection in the experimental group, and at one month after randomization in the control group, the Allergan Infraorbital Hollowing Scale (AIHS) rating will be evaluated by a blinded investigator
Measured: 1 month
At 1 month and 3 months after the last treatment in the experimental group, and at 1 month and 3 months after randomization in the control group, the injection investigator will use AIHS to evaluate the improvement rate of the infraorbital hallowing
Measured: 1 month and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start27 Dec 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infraorbital HollowingStudies 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
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinclair Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongsen Bi, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394076
- Sponsor's protocol ID
- HDM6008A-301
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of MAILI PRECISE With Lidocaine Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population
- ClinicalTrials.gov ID
- NCT06394076
- Acronym / sponsor ID
- HDM6008A-301
- Conditions
- Infraorbital Hollowing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Sinclair Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 1 May 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.
A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of MAILI PRECISE With Lidocaine Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-linked sodium hyaluronate gel for injection containing lidocaine | Experimental | Device: Cross-linked sodium hyaluronate gel for injection containing lidocaineCross-linked sodium hyaluronate gel for injection containing lidocaine |
| No treatment control | No intervention | –No treatment control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 or above (subject to the time of signing the informed consent form) , gender is not limited;
- According to Allergan Infraorbital Rim Scale (AIHS), the subjects were judged by blinded evaluator as having "moderate" or "severe" infraorbital rim hallowing (grade 2-3) in each eye, and both eyes must meet the requirements but do not need to have the same score;
- The injection investigator believes that the hallowing of the infraorbital rim area of the subject can be corrected to grade 0 or grade 1;
- Able and willing to follow the investigator's guidance, following the treatment restrictions in this protocol, and completing all the visits of this trial as required ;
- Able to complete the self-assessment of effectiveness without the use of glasses (contact lenses are accepted if the subject wear contact lenses for all the follow-up visits);
Key exclusion criteria (5 listed)
- Atrophy in the infraorbital area;
- Previous trauma to the infraorbital area, or residual defects, deformities, or scarring in the periorbital or cheek area before screening;
- The investigator considers that there is a large lower eyelid fat pad that will affect the treatment outcome;
- The front most part of the eyeball protrudes forward more than the front most part of the cheek;
- Hyperpigmentation in the infraorbital area (excluding dark circles which are not caused by hyperpigmentation).
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 |
|---|---|---|
| Cross-linked sodium hyaluronate gel for injection containing lidocaineCross-linked sodium hyaluronate gel for injection containing lidocaine | Device | Cross-linked sodium hyaluronate gel for injection containing lidocaine |
Primary outcome
At 3 months after the last treatment in the experimental group, and 3 months after the randomization of the control group, blinded evaluators will use AIHS to evaluate the improvement rate of the infraorbital hallowing.
Time frame: 3 month
2 secondary outcomes
At one month after the last injection in the experimental group, and at one month after randomization in the control group, the Allergan Infraorbital Hollowing Scale (AIHS) rating will be evaluated by a blinded investigator
Time frame: 1 month
At 1 month and 3 months after the last treatment in the experimental group, and at 1 month and 3 months after randomization in the control group, the injection investigator will use AIHS to evaluate the improvement rate of the infraorbital hallowing
Time frame: 1 month and 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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.
Hongsen Bi principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-linked sodium hyaluronate gel for injection containing lidocaine in people with Infraorbital Hollowing, run by Sinclair Pharmaceuticals Limited 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 6 inclusion and 5 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 1 May 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. 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 MENG YAN (020-89168071, clinical.development@sinclairaesthetics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At 3 months after the last treatment in the experimental group, and 3 months after the randomization of the control group, blinded evaluators will use AIHS to evaluate the improvement rate of the infraorbital hallowing. (time frame: 3 month). 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 May 2024.