Skip to main content
OpenTrials
Completed

NCT Number: NCT04647721

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Correction of Moderate to Severe Nasolabial Folds (NLFs)

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital, Merz Investigational Site #0860003, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiesse injectable implant (dermal filler)

Device

Subdermal injection.

Other names: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.

Restylane injectable implant (dermal filler)

Device

Subdermal injection.

Other names: Hyaluronic acid

Primary outcomes

  1. Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS)

    Time frame: Baseline and Week 24 after last injection, up to 28 weeks

    Severity of the nasolabial folds (NLFs) was assessed and measured using the 5-point Wrinkle Severity Rating Scale (WSRS), where 1=absent and 5=extreme. A lower score indicates better outcome.

Secondary outcomes

  1. Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24

    Time frame: Week 24 after last injection, up to 28 weeks

    The Investigator Global Aesthetic Improvement Scale is a subjective assessment where the treating physician describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). The investigator was asked to rate each NLF separately and select the rating that best applied when asked "What is the overall impression of aesthetic change of the subject's NLF due to treatment, compared to the pretreatment photograph". Improvement was defined as a rating of +1, +2, or +3. The higher the iGAIS score, the greater the improvement. Proportion refers to percentage of participants.

  2. Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24

    Time frame: Week 24 after last injection, up to 28 weeks

    The Subject Global Aesthetic Improvement Scale is a subjective self-assessment where the subject independently describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). Subjects rated each NLF separately when asked "What is the overall impression of aesthetic change of your NLF due to treatment, compared to the pretreatment photograph?" Improvement is defined as a rating of +1, +2, or +3. The higher the sGAIS score, the greater the improvement. Proportion refers to percentage of participants.

  3. Number of Subjects With Treatment-emergent Adverse Events (AE) Related to Radiesse

    Time frame: Baseline to week 48 after last injection, up to 52 weeks

    Defined as AEs with onset at or after date of first administration of Radiesse. An AE was considered to be "related" if a causal relationship between Radiesse or the treatment procedure and the AE is at least reasonably possible.

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 1, 2020
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.