Temple HollowingEllanse MNCT06972940
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
A study testing Polycaprolactone (PCL) Based Facial Injectable in people with Temple Hollowing, run by AQTIS Medical B.V. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temple Hollowing
- What is being tested?
- Polycaprolactone (PCL) Based Facial Injectable
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2023to 31 Dec 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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;
- Having tattoos, piercings, significant facial hair (e.g., whiskers), scars, deformities, unhealed wounds, active skin diseases or inflammation or infections (e.g., herpes, acne, eczema, dermatitis, psoriasis, and herpes zoster), abscess, cancers or precancerous lesions, etc. above the subnasale that may affect the efficacy evaluation or increase treatment-related risk;
- Subjects with active autoimmune diseases or medical history (e.g. systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis, etc.), active sepsis, and porphyria;
- Subjects with a tendency to form keloids, hypertrophic scars, or any other healing disorders;
- Having received chemotherapy, immunosuppressants, immunomodulatory therapy (e.g., monoclonal antibodies) or systemic corticosteroids (except inhaled corticosteroids) within 3 months prior to enrollment;
- Subjects with severe dysfunction of vital organs (brain, heart, lung, liver, kidney, etc.), such as serious cardiovascular and cerebrovascular diseases, serious lung diseases, liver function (ALT, AST) > 2 times ULN, renal function (Cr) > 1.5 times ULN, uncontrolled diabetes mellitus or epilepsy, and other conditions, as judged by the investigator;
- Subjects who plan to receive filling, wrinkle correction, or surgery at any site above the subnasale during the study period;
- Subjects who received orthodontics, dental implants, denture installation, and any other operations or surgical treatments that affect the upper facial contour within 1 year before enrollment, or are receiving such operations or surgical treatments, or plan to receive such operations or surgical treatments during the study period;
- Subjects who plan to have an obvious weight change (≥10%) within the study period;
- Having participated in other clinical trials within 3 months prior to enrollment in this study or being currently participating in other clinical trials;
- Pregnant or lactating women;
- Women of childbearing potential who plan to become pregnant or fail to use effective contraceptive measures during the study** (female subjects ofchildbearing potential should have a negative pregnancy test prior to the first injection) and male subjects who plan to have a child or are unwilling to use appropriate contraceptive measures;
- Those who are inappropriate to participate in this clinical study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Peking University First Hospital
Beijing, Beijing Municipality
Yan Wu, +8613910978643, 3437477565@qq.com
Hospital
About this study
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
- Being tested
- Polycaprolactone (PCL) Based Facial Injectable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polycaprolactone (PCL) Based Facial InjectableDevice
Polycaprolactone (PCL) Based Facial Injectable
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Polycaprolactone (PCL) Based Facial Injectable | Experimental | Experimental: Polycaprolactone (PCL) Based Facial Injectable Receives: Device: Polycaprolactone (PCL) Based Facial Injectable |
| 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.
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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start3 Jan 2023
- Primary completion12 Oct 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temple 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
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AQTIS Medical B.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972940
- Sponsor's protocol ID
- HDM6007
- Other IDs
- HDM6007
- Acronym
- Ellanse M
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 15 May 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 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06972940
- Acronym / sponsor ID
- Ellanse M / HDM6007
- Conditions
- Temple Hollowing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- AQTIS Medical B.V.University, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 12 Oct 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 May 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Polycaprolactone (PCL) Based Facial Injectable | Experimental | Device: Polycaprolactone (PCL) Based Facial InjectableExperimental: Polycaprolactone (PCL) Based Facial Injectable |
| No treatment control | No intervention | –No treatment control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (27 listed)
- 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;
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 |
|---|---|---|
| Polycaprolactone (PCL) Based Facial InjectablePolycaprolactone (PCL) Based Facial Injectable | Device | Experimental: Polycaprolactone (PCL) Based Facial Injectable |
Primary outcome
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)
Time frame: 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)
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 15 May 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polycaprolactone (PCL) Based Facial Injectable in people with Temple Hollowing, run by AQTIS Medical B.V. 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 5 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 15 May 2025. 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?
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 Meng Yan (020-89168071, Annella.yan@sinclairaesthetics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 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)). 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 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.