PMID- 37348516
OWN - NLM
STAT- MEDLINE
DCOM- 20230918
LR  - 20230918
IS  - 1527-330X (Electronic)
IS  - 1090-820X (Print)
IS  - 1090-820X (Linking)
VI  - 43
IP  - 10
DP  - 2023 Sep 14
TI  - Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.
PG  - NP797-NP806
LID - 10.1093/asj/sjad195 [doi]
AB  - BACKGROUND: Tapencarium (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. 
      OBJECTIVES: The 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. METHODS: 
      Patients (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. RESULTS: The 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). CONCLUSIONS: A 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.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of The 
      Aesthetic Society.
FAU - Shridharani, Sachin M
AU  - Shridharani SM
FAU - Dayan, Steven
AU  - Dayan S
FAU - Biesman, Brian
AU  - Biesman B
FAU - Cohen, Joel
AU  - Cohen J
FAU - Downie, Jeanine
AU  - Downie J
FAU - Jones, Derek
AU  - Jones D
FAU - Shamban, Ava
AU  - Shamban A
FAU - Fabi, Sabrina
AU  - Fabi S
FAU - Yoelin, Steve
AU  - Yoelin S
FAU - Fagien, Steven
AU  - Fagien S
FAU - Ablon, Glynis
AU  - Ablon G
FAU - Gold, Michael
AU  - Gold M
FAU - Gueta, Racheli
AU  - Gueta R
FAU - Walker, Patricia
AU  - Walker P
LA  - eng
GR  - Raziel Therapeutics Ltd/
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - Aesthet Surg J
JT  - Aesthetic surgery journal
JID - 9707469
RN  - 0 (RZL-012)
RN  - 005990WHZZ (Deoxycholic Acid)
SB  - IM
MH  - Humans
MH  - Adolescent
MH  - Young Adult
MH  - Adult
MH  - Middle Aged
MH  - Aged
MH  - Injections, Subcutaneous
MH  - *Deoxycholic Acid
MH  - *Cosmetic Techniques/adverse effects
MH  - Subcutaneous Fat/diagnostic imaging
MH  - Double-Blind Method
MH  - Treatment Outcome
PMC - PMC10501747
EDAT- 2023/06/23 01:10
MHDA- 2023/09/18 12:43
PMCR- 2023/06/22
CRDT- 2023/06/22 18:43
PHST- 2023/09/18 12:43 [medline]
PHST- 2023/06/23 01:10 [pubmed]
PHST- 2023/06/22 18:43 [entrez]
PHST- 2023/06/22 00:00 [pmc-release]
AID - 7205315 [pii]
AID - sjad195 [pii]
AID - 10.1093/asj/sjad195 [doi]
PST - ppublish
SO  - Aesthet Surg J. 2023 Sep 14;43(10):NP797-NP806. doi: 10.1093/asj/sjad195.