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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Prospective, Multicenter, Randomized, No-treatment Controlled, Assessor-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Gel for Injection to Improve Temple Hollowing in Chinese Adults

NCT06972940

Temple Hollowing

RECRUITING NA

A Prospective, Multicenter, Blind, Randomized Controlled, Optimal Clinical Trial to Evaluate the Safety and Efficacy of Medical Collagen Fillers for Facial Dermal Tissue Filling to Correct Frontal Wrinkles (crow's Feet)

NCT06703294

Intentional Correction of Forehead Wrinkles (crow's Feet)

NOT_YET_RECRUITING PHASE3

Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation

NCT06385171

Wrinkle

RECRUITING

Comparing Injections With Poly-L-Lactic Acid in the Temporal Fossa vs. Extended Temporal Fossa + Hairline

NCT06337747

Aging

COMPLETED NA

Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

NCT04132518

Midface Volume Deficit

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Forehead Contouring

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

the method of endpoint blind evaluation is adopted, that is, it's blinded for the evaluator.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Polycaprolactone (PCL) Based Facial Injectable

Group Type EXPERIMENTAL

Polycaprolactone (PCL) Based Facial Injectable

Intervention Type DEVICE

Polycaprolactone (PCL) Based Facial Injectable

no treatment control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polycaprolactone (PCL) Based Facial Injectable

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes