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

April 25, 2025 updated by: AQTIS Medical B.V.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Guangdong Second Provincial General Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510317
        • Not yet recruiting
        • Guangdong Second Provincial General Hospital
        • Contact:
        • Contact:
          • WEIJIN HONG
          • Phone Number: 02089168071
        • Principal Investigator:
          • shengkang luo
        • Sub-Investigator:
          • weijin hong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: no treatment control
Experimental: Polycaprolactone (PCL) Based Facial Injectable
Device: Polycaprolactone (PCL) Based Facial Injectable
Polycaprolactone (PCL) Based Facial Injectable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
at Months 1, 3, 6, 9 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AQTIS Medical B.V.

Investigators

  • Principal Investigator: SHENGKANG LUO, Guangdong Second People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HDM6009A-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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