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

ConditionsSystemic Sclerosis (SSc)Raynaud Disease Secondary to Scleroderma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKhon Kaen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

SSc patients aged between 18 and 70 years

Diagnosed according to ACR/EULAR 2013 classification criteria20

Having RP with/without DU on fingers or toes

Understand and able to read and write Thai language

Disqualifiers

History of allergy or hypersensitivity to Botulinum toxin or ISDN

Overlap with other connective tissue diseases

Documented having peripheral arterial disease or vasculitis that affected vascular supply of fingers or toes

Current use of 2% ISDN cream for treatment of RP

Trial design

Design model

Parallel

Treatments tested in this trial

  • Botulinum toxin A via microneedle

    Drug

    Botulinum toxin A plus cream placebo

  • Control (Normal saline)

    Other intervention

    Normal saline via microneedles plus isosorbide dinitrate cream

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in distal digit temperature at 4 Weeks

The change in distal digit temperature is evaluated using an infrared thermometer from baseline to 4 weeks after treatment.

Time frame
Baseline and 4 weeks after treatment

Secondary outcomes

1

Change from baseline in Raynaud's Phenomenon pain severity score on the Visual Analogue Scale (VAS)

The change in pain severity related to Raynaud's phenomenon is assessed using the Visual Analogue Scale (VAS). The VAS ranges from a minimum value of 0 to a maximum value of 100, where 0 represents no pain and 100 represents the worst imaginable pain. Higher scores indicate a worse outcome (greater pain intensity).

Time frame
Baseline to 1 week, baseline to 4 weeks, and baseline to 12 weeks after treatment
2

Number of participants experiencing local adverse events at the application site

The safety and tolerability of the intervention are evaluated by recording the number of participants who develop localized adverse events (including erythema, bleeding, dermatitis, local infection, or intolerable pain) at the microneedle pad application site.

Time frame
1 week, 4 weeks, and 12 weeks after treatment
3

Change from baseline in Raynaud's Condition Score (RCS)

The daily clinical severity and frequency of Raynaud's phenomenon attacks are evaluated using the Raynaud's Condition Score (RCS). The RCS is a self-assessment scale ranging from 0 to 10, where 0 represents no difficulty or severity and 10 represents extreme difficulty or severity. Higher numerical values indicate greater symptom severity and functional impairment.

Time frame
Baseline to 1 week, baseline to 4 weeks, and baseline to 12 weeks after treatment
4

The progression of Raynaud's phenomenon (RP) to digital ulcer (DU)

The progression of RP to DU using numbers of DU at 1, 4 , and 12 weeks after treatment

Time frame
1, 4, and 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Khon Kaen University

Lead sponsor

Srinagarind Hospital, Khon Kaen University

Collaborator

National Science and Technology Development Agency, Thailand

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: