Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2022-04-27

Brief Summary

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

Effectiveness: The purpose of this study is to demonstrate the non-inferiority of Radiesse (CaHA) to Restylane (HA) following subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs.

Safety: To evaluate the incidence and type of adverse events and serious adverse events.

Related Clinical Trials

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

Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Nasolabial Folds in China

NCT03282357

Correction of the Moderate to Severe Nasolabial Folds

COMPLETED NA

RHA® 4 NLF Cannula

NCT04754646

Wrinkle Nasolabial Fold Aging

COMPLETED NA

Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSE® (+) Lidocaine) in the Treatment of Ageing Signs in the Face

NCT03650387

Signs of Facial Aging With Volume Loss in the Upper Cheeks, Nasolabial Folds and Marionette Lines

COMPLETED NA

A Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction

NCT06351293

Wrinkle

COMPLETED NA

To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds

NCT04224649

Nasolabial FOLD

UNKNOWN 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.

Correction of Moderate to Severe Nasolabial Folds (NLFs)

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Split-face

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

Left side Radiesse® / Right side Restylane®

Group Type EXPERIMENTAL

Radiesse injectable implant (dermal filler)

Intervention Type DEVICE

Subdermal injection.

Restylane injectable implant (dermal filler)

Intervention Type DEVICE

Subdermal injection.

Left side Restylane® / Right side Radiesse®

Group Type EXPERIMENTAL

Radiesse injectable implant (dermal filler)

Intervention Type DEVICE

Subdermal injection.

Restylane injectable implant (dermal filler)

Intervention Type DEVICE

Subdermal injection.

Interventions

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

Radiesse injectable implant (dermal filler)

Subdermal injection.

Intervention Type DEVICE

Restylane injectable implant (dermal filler)

Subdermal injection.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Calcium hydroxylapatite particles suspended in an aqueous based gel carrier. Hyaluronic acid

Eligibility Criteria

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

Inclusion Criteria

* Has symmetrical NLFs, with the same WSRS score of 3 or 4 (moderate or severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator.
* Is ≥ 22 and ≤ 65 years of age.
* Is willing to abstain from all other aesthetic treatments on any part of the face, including but not limited to injectable fillers, implants, neurotoxin, skin peels, laser treatments, surgical treatments, etc. for the trial's duration.

Exclusion Criteria

* Has an acute inflammatory process or active infection at the injection site.
* Has received mid- and/or lower-facial region treatments with any dermal fillers.
* Has received facial dermal therapies.
* Had prior surgery in the mid- and/or lower-facial area, including the NLFs, or has a permanent implant or graft in the mid- and/or lowerfacial area that could interfere with effectiveness assessments.

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No