A randomized, double‐blind , multi‐center , placebo‐controlled, Phase 2 clinical trial to evaluate the efficacy and safety of DWJ211 in the treatment of moderate to severe submental fat

Abstract

Excessive accumulation of submental fat (SMF) causes a lower face cosmetic problem. A lipolytic injectable has recently been developed as a solution. The objective of this study is to investigate the effects and safety of DWJ211 (a newly developed lipolytic injectable) in the reduction of SMF and to identify the optimum dose. In this multi‐center, double‐blind, placebo‐controlled study, subjects with moderate to severe SMF were randomized to injections of DWJ211 0.5%, DWJ211 1%, DWJ211 2% or placebo in the submental area, every 4 weeks, up to Week 12. Efficacy was determined by improvements in physician‐assisted SMF rating scales (PA‐SMFRS) and subject‐assisted SMF rating scales (SA‐SMFRS) 4 weeks after the last treatment (Week 16). Safety was assessed by inquiries, subject diary entries of adverse events, laboratory tests, and vital sign checks. Of 140 enrolled subjects, 136 were included in the analysis. The proportions of subjects, who achieved ≥1‐grade improvement on the PA‐SMFRS were 41.7%, 65.7%, 84.4%, and 72.7%, and the proportions of subjects, who achieved ≥1‐grade improvement on the SA‐SMFRS were 50.0%, 71.4%, 93.8%, and 81.8% for the placebo, DWJ211 0.5%, DWJ211 1%, and DWJ211 2% group, respectively. Adverse drug reactions (ADRs) were more common in each of the treatment groups compared with placebo, with the most common ADR being injection site pain. No subjects experienced any serious adverse events. In conclusion, the 1% DWJ211 dose was beneficial for SMF reduction and had a tolerable safety profile. Thus, we selected 1% as the dose to be tested in a Phase 3 clinical trial.

Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat

“…16,17 Deoxycholic acid, an injectable product for chemical lipolysis, also carries significant side effects, such as frequent complications like pain, erythema, edema, and induration due to local tissue response, and further requires multiple treatments across numerous weeks. 10,18 The most recent exciting technologies to minimize recovery time are RF and HIFU; both are noninvasive contouring devices that are placed over the epidermis and emit RF or ultrasonic energy that preferentially heats fat more than other tissue types. Compared with other treatment options for reducing submental fat, these energy devices have an advantage in downtime and safety profiles after noninvasive procedures.…”

“…16,17 Deoxycholic acid, an injectable product for chemical lipolysis, also carries significant side effects, such as frequent complications like pain, erythema, edema, and induration due to local tissue response, and further requires multiple treatments across numerous weeks. 10,18…”

“…Inclusion criteria were adults aged 20 years and older with excess submental fat on a grade of 1;4, as assessed by the Physician-Assisted Submental Fat Rating Scale (PA-SMFRS). 10 The exclusion criteria were as follows: mental impairment, infectious disease, history of keloid development, pregnancy, pacemaker, the use of anticoagulants, and undergoing a face-lift procedure within the previous 6 months.…”