Recruiting PHASE4 Raynaud Phenomenon

New treatment option for Raynaud Phenomenon

Official title Botulinum Toxin in Raynaud's Phenomenon

ClinicalTrials.gov ID: NCT05125029

What this study is testing

What is Botulinum toxin?

Botulinum toxin is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for raynaud phenomenon.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Raynaud's Phenomenon (RP) is the most common vasospastic disorder encountered by hand surgeons with an estimated prevalence of 5% in the general population. It's manifestations are broad, and can range from minor to severe.
  • Phase 4: studies an already-approved treatment
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...

You likely can't join if

  • 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...
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Atlanta, Georgia, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.