Evidence map›Paper›PMID 38934231›Full record

Trial reportJournal of cosmetic dermatology2024

Long-term duration and safety of Radiesse (+) for the treatment of jawline.

Jeremy B Green, Roberta Del Campo, Alan J Durkin, David K Funt, Nicole Nasrallah, Keith Martinez, Amir Moradi

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of cosmetic dermatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03583359 (Evaluation of Effectiveness and Safety of Radiesse), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03583359 nacompletednot on this map

Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline

TypeinterventionalSponsorMerz North America, Inc.Ran2018 to 2020Enrolled180ConditionsImprovement of Jawline ContourArmsRadiesse (+)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Jeremy B GreenSkin Research Institute and Skin Associates of South Florida, Coral Gables, Florida, USA.
Roberta Del CampoDel Campo Dermatology, Miami, Florida, USA.
Alan J DurkinOcean Drive Plastic Surgery and MedSpa, Vero Beach, Florida, USA.
David K FuntIcahn School of Medicine, Mount Sinai Hospital, New York, New York, USA.
Nicole NasrallahMerz North America, Inc., Raleigh, North Carolina, USA.
Keith MartinezMerz North America, Inc., Raleigh, North Carolina, USA.
Amir MoradiPrivate Practice, Vista, California, USA.

Funding

Merz Aesthetics North America
6 · The paper itself

Abstract

backgroundCalcium hydroxyapatite (CaHA)-carboxymethylcellulose (CMC)+ has unique properties that make it optimal for lifting, contouring, and defining the jawline. This long-term follow-up of a randomized, multicenter, rater-blinded trial reports efficacy and safety of CaHA-CMC(+) through 48 and up to 60 weeks post-treatment.

methodsEligible patients were randomized (2:1) to the treatment or the control/delayed treatment group to receive CaHA-CMC(+) injections in both jawlines. While touch-ups were permitted 4 weeks post-treatment for both groups, only the treatment group was eligible for optional retreatment after 48 weeks. The primary outcome was ≥1-point improvement on both jawlines on the Merz Jawline Assessment Scale (MJAS); secondary endpoints included the Subject Global Aesthetic Improvement Scale (SGAIS) among others. Post hoc analysis included pooling up to 48-week data from the combined treatment and control/delayed groups and 60-week data for the treatment group.

resultsOverall, 175 received treatment. MJAS responder rates were 77.9%, 78.7%, and 62.9% at 12, 24, and 48 weeks post-treatment, respectively. Responder rate on the MJAS at 60 weeks was 74.6% for those who received retreatment and 43.5% for those patients who received only the initial and touchup treatments. SGAIS scores demonstrated 93.4%, 85.6%, and 68.5% of patients rated themselves very much improved after 12, 24, and 48 weeks, respectively. Adverse events consisted of procedure or CaHA-CMC(+)-related events that were mostly resolved and overwhelmingly mild.

conclusionsCaHA-CMC(+) produced clinically meaningful and long-lasting improvements in jawline contour and was well tolerated in patients through 60 weeks.

trial registrationClinicalTrials.gov Identifier: NCT03583359.

Indexed as

Carboxymethylcellulose SodiumCosmetic TechniquesDurapatiteSkin AgingAdultAgedDermal FillersEstheticsFaceFemaleFollow-Up StudiesHumansMaleMiddle AgedPatient SatisfactionSingle-Blind MethodCarboxymethylcellulose SodiumDermal FillersDurapatitecalcium hydroxylapatitedermal fillerfacial rejuvenationjawlinevolume restoration

Identifiers

PMID38934231
PMCPMC13649112

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.