Clinical Research Directory

Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon

Sponsor: Khon Kaen University

Summary

Raynaud's Phenomenon (RP), a vasospastic disorder causing digital ischemia and potential tissue necrosis, is effectively treated with Botulinum Toxin Type A (BTX-A) in refractory cases. However, standard administration requires painful, invasive injections that risk infection and localized muscle weakness. To address these limitations, this randomized, placebo-controlled, parallel-group study evaluates a microneedle delivery system designed to reach the dermis while avoiding systemic circulation. By penetrating 70-80% of their height, these microneedles aim to improve hand function and symptom scores for adult systemic sclerosis patients through a more comfortable, portable, and less invasive method that increases delivery surface area while minimizing pain.

Official title: Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon and Digital Ulcers in Systemic Sclerosis: A Randomized Placebo-Controlled Trial

Key Details

Conditions

Interventions