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

NCT07759557 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: Botox for scleroderma-RaynaudKhon Kaen University
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

systemic sclerosis; scleroderma related disorders; Infrared Thermography; Botulinum toxin A; Microneedle pad injection; Topical nitrate; Clinical Trial; vasodilator

Outcome Measures

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.

  Baseline and 4 weeks after treatment

Secondary Outcomes (8)

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

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

• Number of participants experiencing local adverse events at the application site

  1 week, 4 weeks, and 12 weeks after treatment

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

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

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

  1, 4, and 12 weeks

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

  1, 4 , and 12 weeks after treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

Group A: Botulinum toxin A with placebo cream

Drug: Botulinum toxin A via microneedle

Control group

PLACEBO COMPARATOR

Group B: Placebo botulinum A with isosorbide dinitrate cream

Other: Control (Normal saline)

Interventions

Botulinum toxin A via microneedle DRUG

Botulinum toxin A plus cream placebo

Intervention group

Control (Normal saline) OTHER

Normal saline via microneedles plus isosorbide dinitrate cream

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Stable steroid, immunosuppressant, and vasodilator including CCB, PDE5i for at least 4 weeks before enrollment

You may not qualify if:

• 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
• Current use vasoconstrictor or medication that has vasoconstrictor effect such as ergotamine sulfate, beta-blocker
• Pregnancy and lactating patients
• Bedridden and confined to no self-care
• Evidence of active malignant disease
• Active infection or sepsis
• Localized infection of hand
• Impaired of intrinsic muscle hand function
• Active smoker
• Prior upper extremity vascular surgery, including surgical sympathectomy within 1 month before enrollment

Sponsors & Collaborators

• Khon Kaen University: lead
• Srinagarind Hospital, Khon Kaen University: collaborator
• National Science and Technology Development Agency, Thailand: collaborator

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Chingching Foocharoen, MD

CONTACT

66906784212; fching@kku.ac.th

Sasithorn Sriyotee, BSc.

CONTACT

66946539656; shrimm2@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The placebo has been assigned for the controlled group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomized, placebo-controlled, parallel-group study

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: August 12, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08