Injectable treatment to improve forehead contour

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

This study is testing a new injectable treatment to see if it can improve the shape of the forehead for people looking for cosmetic enhancements.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 189 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AQTIS Medical B.V. (Academic / other)
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06380972 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a polycaprolactone-based injectable treatment aimed at enhancing forehead contour. It is a multicenter, randomized, evaluator-blinded trial that compares the treatment group to a no-treatment control group. Participants will be assessed for improvements in forehead contour using the Asian Sloping Forehead Scale. The study aims to provide a scientifically rigorous evaluation of this new injectable option for patients seeking cosmetic enhancement.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe forehead contour deficiencies.

Not a fit: Patients with a history of severe allergies or those who are allergic to the components of the injectable will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide patients with a non-surgical option to improve forehead aesthetics.

How similar studies have performed: While similar injectable treatments have shown promise in cosmetic applications, the specific use of polycaprolactone for forehead contouring is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. ≥ 18 years of age (whichever is the time of signing informed consent) of either sex;
2. Subjects who are seeking treatment for forehead contour improvement;
3. 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);
4. Subjects who are in good health and suitable for receiving treatment for forehead contour improvement as assessed by the investigator;
5. 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).

Exclusion Criteria:

1. 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;
2. 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;
3. 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;
4. 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;
5. 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;

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Guangdong Second Provincial General Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Guangdong Second Provincial General Hospital — Guangzhou, China (Recruiting)

Study contacts

• Principal investigator: Shengkang Luo — Guangdong Second People's Hospital
• Study coordinator: Meng Yan

Conditions Forehead Contouring