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

Merz Pharmaceuticals

Status: Completed

Conditions: Correction of Moderate to Severe Nasolabial Folds (NLFs)

Treatments: Device: Radiesse injectable implant (dermal filler); Device: Restylane injectable implant (dermal filler)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04647721

M900311009

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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134 participants in 2 patient groups

Left side Radiesse® / Right side Restylane®

Experimental group

Treatment:

Device: Restylane injectable implant (dermal filler)

Device: Radiesse injectable implant (dermal filler)

Left side Restylane® / Right side Radiesse®

Experimental group

Treatment:

Device: Restylane injectable implant (dermal filler)

Device: Radiesse injectable implant (dermal filler)