Evidence map›Paper›PMID 37348516›Full record

Trial reportAesthetic surgery journal2023

Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.

Sachin M Shridharani, Steven Dayan, Brian Biesman, Joel Cohen, Jeanine Downie, Derek Jones, Ava Shamban, Sabrina Fabi, Steve Yoelin, Steven Fagien and 4 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Aesthetic surgery journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.3field-weighted citation impact, top 20% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Pilot Study: Repeated Utenpanium (RZL-012) Treatment for Submental Fat Reduction.Plastic and reconstructive surgery. Global open · 2026
    Article
  3. 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

14 authors at 5 institutions in 1 country.

Sachin M Shridharani
Steven Dayan
Brian Biesman
Joel Cohen
Jeanine Downie
Derek Jones
Ava Shamban
Sabrina Fabi
Steve Yoelin
Steven Fagien
Glynis Ablon
Michael Gold
Racheli Gueta
Patricia Walker
Ablon Skin Institute and Research Center · USBoca Raton Regional Hospital · USDenova Research · USMontclair State University · USTennessee Clinical Research Center · US

Funding

Raziel Therapeutics Ltd
6 · The paper itself

Abstract

backgroundTapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume.

objectivesThe goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction.

methodsPatients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment.

resultsThe proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs).

conclusionsA single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study. LEVEL OF EVIDENCE: 1:

Indexed as

Cosmetic TechniquesDeoxycholic AcidAdolescentAdultAgedCarbazolesDouble-Blind MethodHumansInjections, SubcutaneousMiddle AgedSubcutaneous FatTreatment OutcomeYoung AdultCarbazolesDeoxycholic AcidRZL-012

Identifiers

PMID37348516
PMCPMC10501747
OpenAlexW4381716473

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.