Botulinum Toxin for Raynaud's Disease

Recruiting in Palo Alto (17 mi)

Overseen by Paul A Ghareeb, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Emory University

Disqualifiers: Under 18, Prior BT, Active infection, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial aims to test if Botox can help patients with severe Raynaud's Phenomenon who don't respond to other treatments. Botox is injected into the fingers to relax muscles around blood vessels, improving blood flow and reducing symptoms like pain and tissue damage. Botox has been used primarily for treating facial wrinkles and has shown effectiveness in treating excessive underarm sweating.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications, but it does mention that patients who have recently changed their RP treatment in the past 4 weeks are excluded. This suggests that maintaining a stable medication regimen might be important.

What data supports the effectiveness of the drug Botulinum Toxin for Raynaud's Disease?

Research shows that Botulinum Toxin A can improve blood flow and relieve symptoms in patients with Raynaud's phenomenon, including those with severe cases and those associated with scleroderma. Patients have reported symptom improvement and healing of ulcers after treatment, with benefits lasting up to a year.

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How is the drug Botulinum Toxin unique in treating Raynaud's Disease?

Botulinum Toxin is unique for Raynaud's Disease because it targets the vasospasm (sudden narrowing of blood vessels) directly, which is not always effectively managed by existing medications. It is administered through injections, and patients have reported symptom relief lasting up to a year, which is longer than many other treatments.

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Eligibility Criteria

This trial is for adults over 18 with moderate to severe Raynaud's Phenomenon (RP) that hasn't improved after 3 months of standard treatment, or those with severe RP showing tissue loss. It excludes anyone under 18, recent changes in RP meds, past year BT treatments for RP, prior surgery for RP, or active infection/allergy at the injection site.

Inclusion Criteria

My severe Raynaud's phenomenon hasn't improved after 3 months of treatment.

I am 18 years old or older.

Exclusion Criteria

I am under 18 years old.

I have been treated with BT for RP within the last year.

I have not changed my RP treatment in the last 4 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Botulinum toxin or placebo injections into the fingers to evaluate efficacy in treating Raynaud's Phenomenon

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in finger temperature, tissue oximetry, and various pain and function scores

24 weeks

Regular follow-up visits at baseline, 4, 12, 16, 20, and 24 weeks, with some visits conducted via telephone

Participant Groups

The study aims to test the effectiveness of Botulinum toxin (BT) in treating Raynaud's Phenomenon that doesn't respond well to usual treatments. The focus is on both objective and subjective outcomes to see how well BT works.

Group I: 10 units of BT per digit Active Control 1 Intervention

Prior to injection, patients will wait in a temperature controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. Once a patient is randomly selected via our randomization process, BT will be reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon who will be performing the injection will be sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT will be sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head will be used as a standardized anatomic landmark for injection both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize probability of proper anatomic placement of the drug.

Group II: Placebo Active Control 1 Intervention

Prior to injection, patients will wait in a temperature controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. Once a patient is randomly selected via our randomization process, BT will be reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon who will be performing the injection will be sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT will be sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head will be used as a standardized anatomic landmark for injection both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize probability of proper anatomic placement of the drug.

Group III: 20 units of BT per digit Active Control 1 Intervention

Prior to injection, patients will wait in a temperature controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. Once a patient is randomly selected via our randomization process, BT will be reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon who will be performing the injection will be sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT will be sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head will be used as a standardized anatomic landmark for injection both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize probability of proper anatomic placement of the drug.

Botulinum Toxin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Botox for:

• Facial wrinkles
• Blepharospasm
• Strabismus
• Axillary hyperhidrosis
• Migraine prophylaxis
• Overactive bladder
• Neurogenic detrusor overactivity

🇪🇺 Approved in European Union as Botox for:

• Facial wrinkles
• Blepharospasm
• Strabismus
• Axillary hyperhidrosis
• Migraine prophylaxis
• Overactive bladder
• Neurogenic detrusor overactivity
• Spasticity

🇨🇦 Approved in Canada as Botox for:

• Facial wrinkles
• Blepharospasm
• Strabismus
• Axillary hyperhidrosis
• Migraine prophylaxis
• Overactive bladder
• Neurogenic detrusor overactivity
• Spasticity

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Emory University Hospital Atlanta, GA

Who Is Running the Clinical Trial?

Emory University Lead Sponsor

American Society for Surgery of the Hand Collaborator

References

1. Poland pubmed.ncbi.nlm.nih.gov

Botulinum toxin A in the treatment of Raynaud's phenomenon: a systematic review. [2022] The management of Raynaud's phenomenon in its most severe form is challenging, and current medical and surgical treatment methods frequently do not lead to optimal symptom control and prevention of ischemic complications. The aim of the study was to critically evaluate all existing evidence on the use of botulinum toxin A in the management of Raynaud's phenomenon.

2. United States pubmed.ncbi.nlm.nih.gov

The Therapeutic Efficacy of Botulinum Toxin in Treating Scleroderma-Associated Raynaud's Phenomenon: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. [2022] To assess the therapeutic efficacy of local injections of botulinum toxin type A (Btx-A) in improving blood flow to the hands of patients with Raynaud's phenomenon (RP) secondary to scleroderma.

3. United States pubmed.ncbi.nlm.nih.gov

The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon: A Case Series. [2020] Raynaud's phenomenon (RP) is a relatively common syndrome occurring alone or in combination with autoimmune and inflammatory diseases. It is characterized by pain and ulceration due to vasospasm in response to cold and stress, most often affecting the digits. Although pharmacologic treatment for this condition exists, it is not always efficacious. Our case series demonstrates the use of abobotulinum toxin A in the treatment of RP. We report the cases of four patients who received injections of abobotulinum toxin A to treat their mild to severe RP symptoms. They experienced clinical improvement for up to one year after treatment.

4. New Zealand pubmed.ncbi.nlm.nih.gov

The mechanism of botulinum A on Raynaud syndrome. [2022] Botulinum neurotoxin type A (BoNT/A) is emerging as a treatment modality for Raynaud's phenomenon (RP). However, the mechanism of the role of BoNT/A in antagonizing the constriction of arteriola in RP remains unclear.

5. Germany pubmed.ncbi.nlm.nih.gov

Targeted high concentration botulinum toxin A injections in patients with Raynaud's phenomenon: a retrospective single-centre experience. [2021] Raynaud's phenomenon is a vasospastic condition affecting hands and feet which may lead to rest pain, ischemic ulcers and gangrene. Botulinum toxin A has been shown to improve peripheral circulation and relieve vasospastic symptoms. Our aim was to assess our treatment outcomes following Botulinum toxin A injections in patients with Raynaud's phenomenon and to explore the importance of toxin concentration and injection sites. Retrospective chart review of patients with primary and secondary Raynaud's syndrome treated with Botulinum toxin A injections and a literature review was conducted. The toxin dose, injection sites, symptom relief, healing of ulcers and complications were assessed. A total of 30 treatment episodes over a 7½ year period were included. All patients had failed medical management. Botulinum toxin A injection was injected primarily in the vicinity of the palmar digital neurovascular bundle. The average total Botulinum toxin A dose injected was 156 U and the concentration was 50 U/ml. All patients reported an improvement in symptoms and healing of digital ulcers. One patient reported a temporary muscle weakness. Six patients had a single treatment episode with long term benefit. Systemic sclerosis patients had an average of 6-month interval between treatment episodes. Higher doses of Botulinum toxin A has been well tolerated with no long term adverse effects. Our study shows that targeted low volume higher concentration Botulinum toxin A injections are effective in treating Raynaud's phenomenon.

6. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin A treatment of Raynaud's phenomenon: a review. [2022] Botulinum toxin A has conventionally been used in the upper extremity to treat spasticity resulting from stroke, paraplegia, and dystonia. Recently, it has been used to relieve symptoms of vasospasm in Raynaud's phenomenon. This review summarizes the current literature on botulinum toxin A in the treatment of Raynaud's phenomenon and examines the proposed mechanisms of action, suggested techniques of administration, and clinical efficacy.

7. Australia pubmed.ncbi.nlm.nih.gov

Clinical and image improvement of Raynaud's phenomenon after botulinum toxin type A treatment. [2016] Raynaud's phenomenon is often accompanied by pain, digital ulceration and compromised daily activities. Pharmacological therapy or sympathectomies have been administered to diminish these symptoms but existing treatments are not invariably efficacious. A recent case series has described the use of botulinum toxin type A in the treatment of Raynaud's phenomenon. We report two patients with severe or mild Raynaud's phenomenon who were injected with BTX-A; both of whom experienced clinical and image improvement after treatment.