Topical alprostadil in patients with systemic sclerosis.
Research type
Research Study
Full title
A physiological study exploring the digital vascular response to topical alprostadil in patients with systemic sclerosis.
IRAS ID
359229
Contact name
Michael Hughes
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Digital vasculopathy (damage to the blood vessels of the hands/fingers) is a key feature of Systemic Sclerosis (otherwise known as scleroderma) and can result in Raynaud’s Phenomenon (cold hands/feet), digital (finger) ulcers and gangrene. The currently used treatments (a group of drugs called prostanoids) are administered intravenously, requiring a few days stay in hospital. Such treatments are poorly tolerated due to side effects and can require dose reduction or discontinuation of the medicine. There is an unmet need for locally acting, topical medicines (applied to the skin) to treat digital vasculopathy. These would likely be better tolerated (avoiding systemic administration), and more convenient (administered at home).
This is a physiological study to examine the effect of topical alprostadil (an analogue of prostaglandin E1), on digital vasculopathy in patients with Systemic Sclerosis (SSc).Twenty patients with SSc will be recruited o. Participants will be asked to attend Salford Royal Hospital for a single (morning) study visit, lasting approximately two hours. Participants will be asked to sign consent, provide clinical data relating to their condition and have their finger skin thickness assessed (both manually, by a clinician, and automated, by High Frequency Ultrasound Imaging).
Participants will then receive the treatment intervention. Alprostadil, placebo (dummy drug) and no treatment will be applied to the index, middle and ring fingers of each participant in a randomised order. Alprostadil and placebo (ointments) will be applied manually by study investigators to the backs of participants fingers. This will be rubbed in for 60 seconds.
Study investigators wish to understand how the skin (blood flow and temperature) reacts to the treatment intervention. To do this they will measure the blood flow (using Laser Doppler Imaging) and temperature (using Thermography) of the participants fingers immediately before, directly after, and then every 10 minutes for 90 minutes after the treatment intervention.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
25/EE/0175
Date of REC Opinion
3 Oct 2025
REC opinion
Further Information Favourable Opinion