Effects of ultraviolet A1 (UVA1) phototherapy in patients with systemic sclerosis (SSc)

Not Applicable

Completed

• Conditions: Systemic sclerosis; Musculoskeletal Diseases

• Registration Number: ISRCTN18986715
• Lead Sponsor: niversity of Dundee (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-08
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients with SSc (both limited and diffuse disease pattern) as diagnosed according to the American College of Rheumatology preliminary classification criteria for this condition
2. SSc patients with cutaneous manifestations
3. SSc patients whose diagnosis was made within the previous 3 years
4. SSc patients who are capable of providing a written informed consent
5. Patients of either sex and aged 18 or above will be recruited

Exclusion Criteria

1. Patients who have received phototherapy in the previous three months
2. Patients who have been started on immunosuppressive treatment within the previous 6 months
3. Patients with localised or generalised morphoea
4. Patients with other sclerodermas other than that associated with SSc. Examples of other forms of sclerodermas include occupational scleroderma (e.g. vinyl chloride disease), ?scleroporphyria? (a generalised morphoea picture arising due to porphyria cutanea tarda), acrosclerosis atrophicans (a late feature of some patterns of Lyme borreliosis, a tick-borne spirochaetal infection) and nephrogenic fibrosing dermopathy.
5. Pregnant or breastfeeding women
6. Subjects who are 18 years or under

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine, within subjects, the effects of high dose UVA1 phototherapy in treating patients with SSc. Clinical and laboratory assessments of skin fibrosis, skin blood flow and endothelial cell function will be undertaken.<br><br>See interventions for details on when these points will be measured.

Secondary Outcome Measures

Name	Time	Method
1. Measure the effect of UVA1 phototherapy on skin fibrosis using clinical assessment of the skin. The elasticiy and tethering of the skin and one of the main components of the skin, collagen, will be analysed. The release of various noxious chemicals and expression of markers of scarring tissues will be examined in the skin biopsy.<br>2. Measure the effect of UVA1 phototherapy on cutaneous blood flow. The ability of the blood vessel to respond to local application of chemicals that are known to increase blood flow, a process called ionotophoresis, will be taken as a measure of the function of the skin blood vessels. <br>3. Assess the affect of UVA1 phototherapy on the release of various noxious chemicals and expression of markers of scarring tissues in fibroblasts in the laboratory<br><br>See interventions for details on when these points will be measured.