Using Botulinum Toxin to Treat Raynaud's Phenomenon
Double Blind RCT to Evaluate the Effect of Botulinum Toxin in Raynaud Phenomenon
This study is testing if Botulinum toxin injections can help people with severe Raynaud's Phenomenon who haven't found relief with regular treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05125029 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Botulinum toxin (BT) in treating patients with Raynaud's Phenomenon (RP) that is resistant to standard medical therapies. It involves a single-site, double-blinded, randomized, placebo-controlled design where participants will receive either BT injections at two different doses or a saline control. The study aims to measure both objective and subjective outcomes related to pain, blood flow, and tissue health in the fingers. The goal is to provide a new treatment option for patients suffering from severe RP.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with moderate to severe Raynaud's Phenomenon that has not responded to standard medical therapy.
Not a fit: Patients who have undergone previous Botulinum toxin treatment for Raynaud's Phenomenon within the past year or those with active infections at the treatment site may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with refractory Raynaud's Phenomenon by reducing pain and preventing tissue loss.
How similar studies have performed: Previous studies have shown promising results for the use of Botulinum toxin in treating Raynaud's Phenomenon, although this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Patients with moderate to severe RP that is not controlled after 3 months of standard medical therapy as prescribed by a Rheumatologist, or severe RP with evidence of tissue loss. Exclusion Criteria: * Patients under the age of 18 * Patients who have previously undergone treatment with BT for RP within the past year * Patients with active infection at the treatment site (active infection defined as cellulitis, purulence, fever, chills, or presence of elevated inflammatory markers, ie. WBC, ESR, CRP) * Patients who have undergone prior digital sympathectomy surgery for RP * Patients who have recently altered their medical regimen for RP within the past 4 weeks * Patients with allergy or contraindication to BT injection
Where this trial is running
Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Paul A Ghareeb, MD — Emory University
- Study coordinator: Paul A Ghareeb, MD
- Email: paul.ghareeb@emory.edu
- Phone: 404-686-8143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.