Systemic Sclerosis (SSc), scleroderma Skin and Connective Tissue Diseases
Conditions
Interventions
Treatment: One off topical application of study drug, alprostadil cream, to one of the fingers of the participant’s dominant hand.
Placebo: One off topical application of study placebo, Lipobase crea
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinician confirmed diagnosis of SSc-spectrum disorder 2. Eighteen years of age or older at the time of recruitment 3. Able to give full informed consent 4. Steady dose (for at least two weeks) of relevant prescribed oral drug (e.g., vasodilatory and vasoactive) therapies for SSc-associated vasculopathy
Exclusion criteria
Exclusion criteria: 1. Presence of digital ulcers on the fingers 2. Patients receiving treatment with intravenous vasodilatory/vasoactive therapy (e.g., iloprost) 3. Finger digital ulcers currently requiring hospital admission (e.g., to receive iloprost) or awaiting surgery for digital vasculopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Digital vasculopathy/microcirculation assessed by surrogate measurement of skin perfusion and temperature using Laser Doppler Imaging and Thermography respectively. This will be measured immediately before treatment and then every 10 minutes after treatment for 90 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Perfusion/temperature measured using laser Doppler imaging / Thermography before application of alprostadil, immediately after, and then every 10 minutes for 90 minutes after application 2. Patient skin score as measured by the modified Rodnan skin score (clinician assessed) and High Frequency ultrasound imaging (visual assessment of thickness) at a single time point 3. Disease duration (time since diagnosis/first symptoms) and disease subtype (localised or systemic) at a single time point | — |
Countries
England, United Kingdom
Contacts
Public ContactPaul New
Outcome results
None listed