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| Effects of ultraviolet A1 (UVA1) phototherapy in patients with systemic sclerosis (SSc) |
| Source of record | UK Trials |
| ISRCTN | ISRCTN18986715 |
| Date ISRCTN assigned | 08/02/2008 |
| Local reference number(s) | N/A |
| Public title | Effects of ultraviolet A1 (UVA1) phototherapy in patients with systemic sclerosis (SSc) |
| Scientific title | Effets of high dose UVA1 phototherapy on cutaneous fibrosis and endothelial cell function in patients with systemic sclerosis |
| Acronym | N/A |
| Disease/condition/study domain | Systemic sclerosis |
| Study hypothesis | One of the characteristic features of systemic sclerosis (SSc) is excessive deposition of collagen within the skin. Such changes are believed to be the results of inappropriate activation of dermal fibroblasts by various inflammatory and pro-fibrotic cytokines, combined with damage to the endothelium. Numerous treatments, some such as immunosuppressive drugs with potentially hazardous side-effects, are currently used with only limited success. Recent pilot studies have reported successful treatment of patients with scleroderma (hard skin) by high dose ultraviolet A1 (UVA1) phototherapy. The hypothesis of this study is high dose UVA1 phototherapy is useful in the treatment of skin fibrosis in patients with SSc through the reduction of collagen deposition and improvement of endothelial functions. |
| Design/methodology | This is a within patient, double blind, sham controlled study. |
| Research ethics review | Pending as of 07/02/2008. Our local ethics committee requires investigators to have registered with ISRCTN before considering their applications. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/04/2008 |
| Anticipated end date | 31/03/2011 |
| Status of trial | Ongoing |
| Target number of participants | 20 |
| Interventions | 1. Intervention: UVA1 photo-irradiation therapy to the patient's arm 2. Control: sham treatment to the patient's arm Patients with early stage SSc will receive a total of twenty phototherapy treatments. Both arms will be placed into similar light boxes but only one arm will receive the UVA1 light therapy treatment. Comparisons will be made by measuring elasticity and collagen content of the skin, but also by looking at skin biopsies, blood vessel function and release of various cytokines and expression of markers of scarring tissues in the skin biopsy. The study will take a total of eight weeks per participant. There will be a total of twenty phototherapy sessions with the duration of treatment at each session being no longer than 50 minutes. This will depend upon the individual and the minimal erythema dose (MED) (the MED is defined as the minimum amount of irradiation at a waveband capable of producing a perceptible erythema) as to how long the phototherapy at each session will take. Assessments will take place at the start of the study, during the treatment and again two weeks after the final treatment session. The following assessments will be performed: Visit 1: day 0 - duration: no longer than 3 hours 1. Written consent 2. Medical history 3. Phototesting 4. Skin elasticity 5. Iontophoresis and scanning laser doppler imaging 5. Skin scan 6. Skin biopsy 7. Haematology and biochemistry blood tests 8. Photograph arms Visit 2: day 6 - duration: no longer than 20 minutes 1. Skin elasticity 2. Skin scan 3. Visual analogue scale 4. 5-point likert scale Visit 3: day 15 - duration: no longer than 2 hours 1. Skin elasticity 2. Iontophoresis and scanning laser doppler imaging 3. Skin scan 4. Skin biopsy (group 1) 5. Haematology and biochemistry blood tests 6. Visual analogue scale 7. 5-point likert scale Visit 4: day 21 - duration: no longer than 20 minutes 1. Skin elasticity 2. Skin scan 3. Photograph arms 4. Visual analogue scale 5. 5-point likert scale Visit 5: 14 days after final treatment - duration: no longer than 2 hours 1. Skin elasticity 2. Iontophoresis and scanning laser doppler imaging 3. Skin scan 4. Skin biopsy (group 2) 5. Haematology and biochemistry blood tests 6. Photograph arms 7. Visual analogue scale 8. 5-point likert scale |
| Primary outcome measure(s) | 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. See interventions for details on when these points will be measured. |
| Secondary outcome measure(s) | 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. 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. 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 See interventions for details on when these points will be measured. |
| Sources of funding | University of Dundee (UK) - University Division of Medicine & Therapeutics Research Fund |
| Sponsor name | University of Dundee (UK) |
| Sponsor details | University Division of Medicine & Therapeutics Ninewells Hospital & Medical School Dundee United Kingdom DD1 9SY |
| Sponsor website | http://www.dundee.ac.uk/ |
| Contact name | Prof Chak Lau |
| Contact details | University Division of Medicine & Therapeutics Ninewells Hospital and Medical School Dundee United Kingdom DD1 9SY |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN18986715 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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