Clinical trial NCT06380972: A Prospective, Randomized, No-treatment Controlled, Evaluator-blinded Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Forehead Contouring
Lead sponsor: AQTIS Medical B.V.
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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;

Primary outcomes:
measure: The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS)
timeFrame: Month 12
Secondary outcomes:
measure: The response rate of forehead contour improvement assessed by blinded investigator using Asian Sloping Forehead Scale (ASFS)
timeFrame: at Months 1, 3, 6 and 9
measure: The response rate of forehead contour improvement assessed by injection investigator using Asian Sloping Forehead Scale (ASFS)
timeFrame: at Months 1, 3, 6, 9 and 12
measure: The global aesthetic improvement rate assessed by the injection investigator based on the Global Aesthetic Improvement Scale (GAIS)
timeFrame: at Months 1, 3, 6, 9 and 12
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
Study officials:
affiliation: Guangdong Second People's Hospital
name: SHENGKANG LUO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.