This month, the next instalment of our ‘What’s new? Upcoming Research on…’ series focuses on Raynaud’s (it is RAM after all)!

Raynaud’s is a very common condition affecting up to 20% of the adult population worldwide, which means there are as many as 10 million people in the UK alone experiencing the condition. It is typically experienced in the fingers, toes, nose, ears or nipples as a response to cold or stress, and can be extremely painful, depending on the severity of the Raynaud’s attack experienced.

When we are exposed to the cold, the body normally response by constricting the blood vessels in a person’s extremities. This reduces blood flow to that area to maintain core body temperature and is a healthy response to a sudden reduction in temperature. For those with Raynaud’s however the narrowing of these blood vessels is more extreme and can be seen by the persons fingers for example changing colour from white to blue, and then to red. At the point where circulation returns it can be extremely painful.

From a survey of the SRUK community we learnt that Raynaud’s attacks can take place multiple times a day, with the average attack lasting 11-30 minutes. Triggered by something as small as ‘walking down the freezer isle in a supermarket’ or ‘walking into a building with air-con’ Raynaud’s attacks can have a significant impact on a person’s life, which is why research seeking to better understand and treat Raynaud’s is so important.

Raynaud’s Research

1. STAR – Symptom Tracking App for Raynaud’s

Firstly we are delighted to announce the launch of STAR, a symptom tracking app for people with Raynaud’s – a brand new SRUK project. Some readers may remember the original version of this app, ‘The Raynaud’s ResearchApp’ which was trialled by nearly 200 members of the SRUK community in 2021. These first users have helped us to develop and refine the app, leading to the launch of STAR. With updated trackers, a new and improved interface, and ability to help you monitor what triggers your Raynaud’s attacks, this app will also support scientific research into Raynaud’s.

By collecting anonymised data on the experiences of people with Raynaud’s, such as the number of Raynaud’s attacks experienced daily, their severity, duration and potential triggers, and allowing research teams to analyse this information, SRUK hopes to drive more research into Raynaud’s, benefitting the 1 in 6 individuals in the UK who experience it.  

If you would like to download STAR, head to our webpage and fill in the online form with your name and email address. You will be emailed with your login details within two-three working days. 

2. Botulinum Toxin (Botox) Clinical Trial

In January 2022 a clinical trial to examine the efficacy of Botulinum Toxin (commonly known as Botox) in the treatment of unmanageable Raynaud’s, began.

Previous research has demonstrated the success of Botulinum Toxin in treating Raynaud’s, increasing blood perfusion to the fingers and decreasing the pain experienced. The current scientific literature on the topic varies in opinion on injection technique, location of the injection, the amount of Botox that should be given and the duration of action. This study, run by Emory University in Georgia USA hopes to elucidate some answers to these questions.

The study will compare a control group who receive a placebo injection to two treatment groups, that will receive different dosages. The treatment will be injected into all of the patient’s fingers.

Researchers will be measuring the change in temperature of the fingers, change in oximetry measure, change in Raynaud’s condition score (a validated outcome measure used to assess the level of difficulty experienced due to RP each day), changes in patient reported outcome measures, and changes in physical function of the hand.

This study seeks to establish a standardised injection technique and dosage, in order to offer a new treatment to people who experience Raynaud’s.

Reference: Botulinum Toxin in Raynaud's Phenomenon - Full Text View - ClinicalTrials.gov
Locations: Emory University Hospital, Georgia USA

3. Pilot Study to Investigate the Effect of Cocoa Flavanol Supplementation in Raynaud’s Phenomenon

Sudden constrictions in blood vessels, which reduce blood flow to the fingers can cause Raynaud’s attacks and symptoms. These attacks can be very painful and reduce an individual’s capacity to use their hands whilst the attack is occurring.

Most Raynaud’s medications come from a class of drugs known as ‘vasodilators’ which work by dilating blood vessels increasing blood flow to extremities and reducing the frequency and severity of Raynaud’s attacks. Treatments which increase nitric oxide levels are particularly effective at achieving this, which is why in 2021 the University of Nottingham wrapped up their study investigating whether supplementing a person’s diet with cocoa flavanols (which increase the bioavailability of nitric oxides) could benefit Raynaud’s symptoms and temperature regulation.

For three months, 30 female participants with Raynaud’s took either a placebo capsule, or a high flavanol cocoa extract each day. They also completed a diet diary. Across the three months various measurements which included blood pressure, skin temperature, ‘core’ temperature, skin blood flow and Raynaud’s symptoms questionnaires were taken.

The results of this study are anticipated in 2022, revealing whether a simple dietary change could be one method of reducing the severity of Raynaud’s symptoms in women. 

4. A Phase 2 Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Adult Participants with Raynaud’s Phenomenon Secondary to Systemic Sclerosis

Much like project 2 (a clinical trial) and project 3 (a pilot study) on our list, most treatments targeting Raynaud’s symptoms aim to treat the blood vessels, and reduce how much they constrict, reducing the severity of a Raynaud’s attack.

Arena Pharmaceuticals are developing a new potential treatment for Raynaud’s. Their investigational drug ‘Temanogrel’ is designed to reduce Raynaud’s symptoms by preventing the constriction of blood vessels by selectively inhibiting the effects of a molecule called serotonin which is usually involved in relaying nerve impulses in the body.   In 2021 this treatment entered phase 2 clinical trials for both secondary Raynaud’s and microvascular obstruction. 48 participants are being recruited from hospitals in both the USA and UK in this multicentre, double blind, placebo-controlled study to assess the effect of Temanogrel on blood flow to the fingers in people who have secondary Raynaud’s.

A range of measurements will be taken from each participant to establish how their blood flow has changed in response to the treatment. These include infrared thermography and laser speckle contrast imaging to assess how participants recover from a ‘cold challenge’ which will stimulate a Raynaud’s attack.

The study is anticipated to be completed in June 2022, with results published by the end of the year. Following this phase 2 trial, if shown to be effective in increasing blood flow to the fingers Temanogrel will likely progress to a phase 3 clinical trial in 2023.

As these amazing projects begin to publish their results, SRUK will make sure to keep you informed – keep an eye on our Research News page for all the latest articles.