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

NCT07759557 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • Systemic Sclerosis (SSc)
  • Raynaud Disease Secondary to Scleroderma

Interventions

DRUG

Botulinum toxin A via microneedle

Botulinum toxin A plus cream placebo

OTHER

Control (Normal saline)

Normal saline via microneedles plus isosorbide dinitrate cream

Sponsors & Collaborators

  • Srinagarind Hospital, Khon Kaen University

    collaborator OTHER

  • National Science and Technology Development Agency, Thailand

    collaborator OTHER_GOV

  • Khon Kaen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-07-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07759557 on ClinicalTrials.gov