A Study to Evaluate the Safety and Effectiveness of Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population

NCT06394076 | Recruiting DMC

• 1 other identifier: HDM6008A-301
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Infraorbital Hollowing

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  1 month and 3 month

Study Arms (2)

Cross-linked sodium hyaluronate gel for injection containing lidocaine

EXPERIMENTAL

Cross-linked sodium hyaluronate gel for injection containing lidocaine

Device: Cross-linked sodium hyaluronate gel for injection containing lidocaine

No treatment control

NO INTERVENTION

No treatment control

Interventions

Cross-linked sodium hyaluronate gel for injection containing lidocaine DEVICE

Cross-linked sodium hyaluronate gel for injection containing lidocaine

Cross-linked sodium hyaluronate gel for injection containing lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sinclair Pharmaceuticals Limited: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Hongsen Bi

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MENG YAN

CONTACT

020-89168071; clinical.development@sinclairaesthetics.com

ZHONGXING ZHANG

CONTACT

020-89168071; Medical.Committee@sinclairaesthetics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 1, 2024
• Study Start: December 27, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

CN (1)