A Prospective, Multicenter, Randomized, No-treatment Controlled, Assessor-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Gel for Injection to Improve Temple Hollowing in Chinese Adults

NCT06972940 | Recruiting

• 1 other identifier: HDM6007
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

A Prospective, Multicenter, Randomized, No-treatment controlled, Assessor-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Gel for Injection to Improve Temple Hollowing in Chinese Adults

Conditions

Temple Hollowing

Outcome Measures

Primary Outcomes (1)

• Primary efficacy endpoint: Response rate of temple hollowing improvement at Month 12 (Month 12 after the last injection in the test group and Month 12 after randomization in the control group, as assessed by a blinded investigator)

  Primary efficacy endpoint: Response rate of temple hollowing improvement at Month 12 (Month 12 after the last injection in the test group and Month 12 after randomization in the control group, as assessed by a blinded investigator)

Study Arms (2)

Experimental: Polycaprolactone (PCL) Based Facial Injectable

EXPERIMENTAL

Experimental: Polycaprolactone (PCL) Based Facial Injectable

Device: Polycaprolactone (PCL) Based Facial Injectable

No treatment control

NO INTERVENTION

No treatment control

Interventions

Polycaprolactone (PCL) Based Facial Injectable DEVICE

Polycaprolactone (PCL) Based Facial Injectable

Experimental: Polycaprolactone (PCL) Based Facial Injectable

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 65 years old (inclusive), male or female;
• Subjects who are willing to receive temple filling treatment;
• Subjects with flat to severe temple hollowing on both sides (i.e. ATHS scores of 1- 4 on two sides, which are not necessarily the same but should have a difference of at most 2) as assessed by the blinded investigators;
• Subjects able to self-assess efficacy without spectacles or with contact lenses;
• Subjects who voluntarily sign the ICF, understand and accept the duration of the study, and will be able and willing to comply with all requirements, including scheduled treatment, follow-up, and other study procedures

You may not qualify if:

• With known allergic reactions to polycaprolactone (PCL),carboxymethylcellulose (CMC), glycerin or any ingredient in the product;
• With known history of severe allergic reactions and multiple severe allergies;
• With abnormal coagulation mechanism (activated partial thromboplastin time (APTT) \> 1.5 times the upper limit of normal) at screening, or having received any thrombolytic agent, anticoagulant, or antiplatelet drug (e.g.,warfarin, aspirin) within 2 weeks prior to enrollment;
• With temple hollowing due to trauma, congenital malformation, or congenital or acquired lipodystrophy;
• With previous or current temporal arteritis;
• With temporomandibular disorders or other mandibular diseases;
• With recurrent temporal headaches, such as temporal tendonitis, and migraine;
• Having received injection of polymethyl methacrylate, silicone, expanded polytetrafluoroethylene, autologous fat, or any other fillers in the temple;
• Having received injection of calcium hydroxyapatite, poly-L-lactic acid, polycaprolactone, or any other fillers in the temple within 2 years before enrollment;
• Having received injection of crosslinked HA or any other unknown materials above the subnasale within 12 months before enrollment (except the injections in nasolabial folds and mid-face);
• Having received collagen injection above the subnasale within 6 months before enrollment (except the injections in nasolabial folds and mid-face);
• Having received injection of non-crosslinked sodium hyaluronate (including skin boosters), short wave therapy, ultrasound therapy, laser or chemical peeling, dermabrasion, or any other treatment within 3 months before enrollment;
• Having received face lifting (thread lift) above the subnasale within 12 months before enrollment;
• Having received radio frequency therapy or botulinum toxin injection above the subnasale within 6 months before enrollment, such as periorbital rhytidectomy, and treatment of masseteric hypertrophy (except the injections in nasolabial folds and mid-face) ;
• Having ever received surgery in the temples, which affects efficacy evaluation as judged by the investigator;

Sponsors & Collaborators

• AQTIS Medical B.V.: lead

Study Sites (1)

Beijing Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Meng Yan

CONTACT

020-89168071; Annella.yan@sinclairaesthetics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the method of endpoint blind evaluation is adopted, that is, it's blinded for the evaluator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: January 3, 2023
• Primary Completion: October 12, 2024
• Study Completion: December 31, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)