epocrates

AAD 2024: Injectable polidocanol demonstrates effectiveness for submental fat treatment

March 18, 2024

Injectable polidocanol was found to be safe and effective for reducing excess submental fat. Polidocanol is currently being developed under 505(b)2 pathway showing less inflammation and release of cytokines TNFα and MCP-1 by macrophages than deoxycholate. The findings, which were presented during the 2024 American Academy of Dermatology Annual Meeting, support the superior efficacy and tolerability of polidocanol compared with current products.

• In this randomized, placebo-controlled trial, researchers enrolled 51 subjects across four research sites into three active treatment arms.
• Each participant received up to six treatments involving up to 50 injections of 0.2 mL each administered four weeks apart.
• Primary endpoints included the Clinician Submental Fat Score (CSFS) and a Patient Submental Fat Score (PSFS) on a 0-4 point scale, along with local skin reactions and safety assessments.
• Two key analysis populations were highlighted at the AAD meeting: the Intent-to-Treat (ITT) and Completer Population (CP). The CP consisted of 40 subjects who had at least 4 treatments, completed treatments per protocol, and showed no significant protocol deviations.
• The ITT analysis of the 3% and 4.5% dose groups demonstrated a ~4-fold increase in ≥ 2-grade improvement in the composite FDA endpoint relative to Kybella, an injectable form of sodium deoxycholic acid (62% vs. 16%).
• In the CP, 80% achieved a 2-grade improvement in the composite endpoint, demonstrating success from both clinician and patient perspectives.
• Patients using 10XB-101 experienced a more rapid onset of efficacy than Kybella, with an average 1-grade improvement after 2 treatments and a 50% achievement of 2-grade improvement by four treatments.
• Tolerability side effects showed a >50% reduction, influencing product adoption positively.

Source:

Darji K. A Phase 2B Clinical Trial. Assessing the Safety and Efficacy of Injectable Polidocanol for Excess Submental Fat Reduction. Late-breaking research: session 1. Presented at: 2024 American Academy of Dermatology Meeting; March 8-12, 2024; San Diego, CA. https://am2024.aad.org/sessions/16895 [link requires log-in].