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

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.

NCT Number	NCT07759557
Lead Sponsor	Khon Kaen University Collaborators: Srinagarind Hospital, Khon Kaen University, National Science and Technology Development Agency, Thailand
Conditions	Systemic Sclerosis (SSc), Raynaud Disease Secondary to Scleroderma
Enrollment	72 participants
Start Date	2026-08-01
Primary Completion	2028-07-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-12