Condition category
Musculoskeletal Diseases
Date applied
07/02/2008
Date assigned
08/02/2008
Last edited
29/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chak Lau

ORCID ID

Contact details

University Division of Medicine & Therapeutics
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effets of high dose UVA1 phototherapy on cutaneous fibrosis and endothelial cell function in patients with systemic sclerosis

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Within patient, double blind, sham controlled study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Systemic sclerosis

Intervention

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

Intervention type

Drug

Phase

Not Specified

Drug names

Ultraviolet A1 (UVA1) phototherapy

Primary outcome measures

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 measures

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.

Overall trial start date

01/04/2008

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

01/04/2008

Recruitment end date

31/03/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Division of Medicine & Therapeutics
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

University Division of Medicine & Therapeutics
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Sponsor type

University/education

Website

http://www.dundee.ac.uk/

Funders

Funder type

University/education

Funder name

University of Dundee (UK) - University Division of Medicine & Therapeutics Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

29/06/2016: No publications found, verifying study status with principal investigator