A Prospective, Randomized, No-treatment Controlled, Evaluator-blinded Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour

NCT06380972 | Recruiting

• 1 other identifier: HDM6009A-301
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Forehead Contouring

Outcome Measures

Primary Outcomes (1)

• The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS)

  Month 12

Secondary Outcomes (3)

• The response rate of forehead contour improvement assessed by blinded investigator using Asian Sloping Forehead Scale (ASFS)

  at Months 1, 3, 6 and 9

• The response rate of forehead contour improvement assessed by injection investigator using Asian Sloping Forehead Scale (ASFS)

  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)

  at Months 1, 3, 6, 9 and 12

Study Arms (2)

Polycaprolactone (PCL) Based Facial Injectable

EXPERIMENTAL

Device: Polycaprolactone (PCL) Based Facial Injectable

no treatment control

NO INTERVENTION

Interventions

Polycaprolactone (PCL) Based Facial Injectable DEVICE

Polycaprolactone (PCL) Based Facial Injectable

Polycaprolactone (PCL) Based Facial Injectable

Eligibility Criteria

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

You may qualify if:

• ≥ 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• AQTIS Medical B.V.: lead

Study Sites (2)

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510317, China

NOT YET RECRUITING

Guangdong Second Provincial General Hospital

Guangzhou, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 22434157 BACKGROUND

• Hong 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.

  PMID: 32740211 BACKGROUND

Study Officials

• SHENGKANG LUO

  Guangdong Second People's 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
• 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: April 19, 2024
• First Posted: April 24, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 29, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)