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

AQTIS Medical B.V.1 site in 1 country189 target enrollmentMarch 1, 2024

ConditionsForehead Contouring

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Forehead Contouring
Sponsor: AQTIS Medical B.V.
Enrollment: 189
Locations: 1
Primary Endpoint: The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 1, 2024

End Date

October 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AQTIS Medical B.V.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥ 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).

Exclusion Criteria

•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;

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)
The response rate of forehead contour improvement assessed by blinded investigator using Asian Sloping Forehead Scale (ASFS)(at Months 1, 3, 6 and 9)