Forehead ContouringNCT06380972
A Prospective, Randomized, No-treatment Controlled, Evaluator-blinded Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour
A study testing Polycaprolactone (PCL) Based Facial Injectable in people with Forehead Contouring, run by AQTIS Medical B.V. at 2 sites in China.
Trial summary
A Prospective, Multicenter, Randomized, No-treatment-controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Based Facial Injectable to Improve Forehead Contour Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Forehead Contouring
- 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
- 189 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2024to Oct 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
- ≥ 18 years of age (whichever is the time of signing informed consent) of either sex;
- Subjects who are seeking treatment for forehead contour improvement;
- Subjects with moderate to severe forehead contour deficiency (i.e., ASFS score of 2-3) as evaluated by blinded investigator according to Asian Sloping Forehead Scale (ASFS);
- Subjects who are in good health and suitable for receiving treatment for forehead contour improvement as assessed by the investigator;
- Subjects who are willing to sign informed consent, understand and accept the duration of the study, and are able and willing to comply with all requirements, including scheduled treatment, follow-up, and other study procedures (including clinical photography).
Who cannot join
- Those with a history of severe allergy or anaphylactic shock or those with a history of allergy which may result in a response to treatment;
- Those with known allergy to polycaprolactone, carboxymethylcellulose, or any of the ingredients in this product, any local anesthetics such as lidocaine or other amide anesthetics;
- Those with tattoos, scars, deformities, non-healing wounds, active skin disease or skin inflammation (e.g., herpes, acne, eczema, dermatitis, psoriasis, herpes zoster, etc.), abscess, cancer or pre-cancerous lesions and so forth on the forehead that may affect the evaluation of efficacy or increase the risk of treatment;
- Those who have received, or plan to receive during the trial, any permanent filler (e.g., polymethyl methacrylate, organic silicon, expanded polytetrafluoroethylene, etc.), autologous fat or unspecified injectables in the frontal region;
- Those who have received treatment on the forehead such as calcium hydroxyapatite (CaHA), poly-L-lactic acid (PLLA), and polycaprolactone (PCL) within 2 years prior to screening or during the planned trial;
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317
Shengkang Luo, 02089168071, luoshengkang63@hotmail.com
WEIJIN HONG, 02089168071
- Recruiting
Guangdong Second Provincial General Hospital
Guangzhou
Sheng kang Luo, 02089168071, luoshengkang63@hotmail.com
About this study
Official title: A Prospective, Multicenter, Randomized, No-treatmentcontrolled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour
A Prospective, Multicenter, Randomized, No-treatment-controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Based Facial Injectable to Improve Forehead Contour
- Conditions
- Forehead Contouring
- 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 |
|---|---|---|
| Polycaprolactone (PCL) Based Facial Injectable | Experimental | Not described Receives: Device: Polycaprolactone (PCL) Based Facial Injectable |
| no treatment control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS)
Measured: Month 12
Secondary outcomes (3)
The response rate of forehead contour improvement assessed by blinded investigator using Asian Sloping Forehead Scale (ASFS)
Measured: at Months 1, 3, 6 and 9
The response rate of forehead contour improvement assessed by injection investigator using Asian Sloping Forehead Scale (ASFS)
Measured: at Months 1, 3, 6, 9 and 12
The global aesthetic improvement rate assessed by the injection investigator based on the Global Aesthetic Improvement Scale (GAIS)
Measured: at Months 1, 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Mar 2024
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Forehead ContouringStudies 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
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AQTIS Medical B.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SHENGKANG LUO, Principal investigator, Guangdong Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380972
- Sponsor's protocol ID
- HDM6009A-301
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Isik S, Sahin I. Contour restoration of the forehead by lipofilling: our experience. Aesthetic Plast Surg. 2012 Aug;36(4):761-6. doi: 10.1007/s00266-011-9800-2. Epub 2012 Mar 22.
PubMed 22434157Hong WJ, Liao ZF, Zeng L, Luo CE, Luo SK. Tomography of the Forehead Arteries and Tailored Filler Injection for Forehead Volumizing and Contouring. Dermatol Surg. 2020 Dec;46(12):1615-1620. doi: 10.1097/DSS.0000000000002561.
PubMed 32740211
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, No-treatmentcontrolled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour
- ClinicalTrials.gov ID
- NCT06380972
- Acronym / sponsor ID
- HDM6009A-301
- Conditions
- Forehead Contouring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- AQTIS Medical B.V.University, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 24 Apr 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 Prospective, Multicenter, Randomized, No-treatment-controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Based Facial Injectable to Improve Forehead Contour
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polycaprolactone (PCL) Based Facial Injectable | Experimental | Device: Polycaprolactone (PCL) Based Facial Injectable |
| no treatment control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years of age (whichever is the time of signing informed consent) of either sex;
- Subjects who are seeking treatment for forehead contour improvement;
- Subjects with moderate to severe forehead contour deficiency (i.e., ASFS score of 2-3) as evaluated by blinded investigator according to Asian Sloping Forehead Scale (ASFS);
- Subjects who are in good health and suitable for receiving treatment for forehead contour improvement as assessed by the investigator;
- Subjects who are willing to sign informed consent, understand and accept the duration of the study, and are able and willing to comply with all requirements, including scheduled treatment, follow-up, and other study procedures (including clinical photography).
Key exclusion criteria (5 listed)
- Those with a history of severe allergy or anaphylactic shock or those with a history of allergy which may result in a response to treatment;
- Those with known allergy to polycaprolactone, carboxymethylcellulose, or any of the ingredients in this product, any local anesthetics such as lidocaine or other amide anesthetics;
- Those with tattoos, scars, deformities, non-healing wounds, active skin disease or skin inflammation (e.g., herpes, acne, eczema, dermatitis, psoriasis, herpes zoster, etc.), abscess, cancer or pre-cancerous lesions and so forth on the forehead that may affect the evaluation of efficacy or increase the risk of treatment;
- Those who have received, or plan to receive during the trial, any permanent filler (e.g., polymethyl methacrylate, organic silicon, expanded polytetrafluoroethylene, etc.), autologous fat or unspecified injectables in the frontal region;
- Those who have received treatment on the forehead such as calcium hydroxyapatite (CaHA), poly-L-lactic acid (PLLA), and polycaprolactone (PCL) within 2 years prior to screening or during the planned trial;
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 | Polycaprolactone (PCL) Based Facial Injectable |
Primary outcome
The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS)
Time frame: Month 12
3 secondary outcomes
The response rate of forehead contour improvement assessed by blinded investigator using Asian Sloping Forehead Scale (ASFS)
Time frame: at Months 1, 3, 6 and 9
The response rate of forehead contour improvement assessed by injection investigator using Asian Sloping Forehead Scale (ASFS)
Time frame: at Months 1, 3, 6, 9 and 12
The global aesthetic improvement rate assessed by the injection investigator based on the Global Aesthetic Improvement Scale (GAIS)
Time frame: at Months 1, 3, 6, 9 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Background: PubMed 22434157Isik S, Sahin I. Contour restoration of the forehead by lipofilling: our experience. Aesthetic Plast Surg. 2012 Aug;36(4):761-6. doi: 10.1007/s00266-011-9800-2. Epub 2012 Mar 22.
- Background: PubMed 32740211Hong WJ, Liao ZF, Zeng L, Luo CE, Luo SK. Tomography of the Forehead Arteries and Tailored Filler Injection for Forehead Volumizing and Contouring. Dermatol Surg. 2020 Dec;46(12):1615-1620. doi: 10.1097/DSS.0000000000002561.
- 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. This study is not recruiting at the moment.
SHENGKANG LUO principal investigator
Guangdong Second People's Hospital
2 sites 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 Forehead Contouring, run by AQTIS Medical B.V. at 2 sites 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 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 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS) (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06380972, which also lists 2 linked publications.
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 29 Apr 2025.