NCT07759557Not yet recruitingPhase 3
Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon
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
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 3 May 2026
- Start date
- Aug 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- Khon Kaen University
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT07759557
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 72
- From Aug 2026 to the primary completion date, Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use vasoconstrictor or medication that has vasoconstrictor effect such as ergotamine sulfate, beta-blocker
- Prior upper extremity vascular surgery, including surgical sympathectomy within 1 month before enrollment
Other illness
- 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
- Evidence of active malignant disease
- Active infection or sepsis
- Localized infection of hand
Other
- Current use of 2% ISDN cream for treatment of RP
- Pregnancy and lactating patients
- Bedridden and confined to no self-care
- Impaired of intrinsic muscle hand function
- Active smoker
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.