Psoriasis Skin and Connective Tissue Diseases Psoriasis
Conditions
Interventions
Research conducted by us and others has informed the initial doses of UVB, incremental dose increases during the course of therapy (to account for photoadaption) and the frequency of delivery of photo
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older (no upper age limit) 2. Able to speak English 3. Able to provide informed consent 4. Has chronic plaque psoriasis 5. Prescribed NbUVB phototherapy 6. Able and willing to attend the phototherapy department regularly
Exclusion criteria
Exclusion criteria: 1. Able to control their psoriasis or already controlled by topical therapy 2. Pregnant 3. Have had significant sun exposure, sun-bed use or previous NbUVB within the last month or be planning significant sun exposure or sun-bed use in the next month 4. Have previously taken, in the last three months any of the following: methotrexate, azathioprine, ciclosporin, biological therapy or systemic steroids for treatment of psoriasis 5. Have previously taken, in the last month, any oral photosensitising medications, including: thiazide diuretics, antibiotics such as tetracyclines and quinolones, non-steroidal anti-inflammatory drugs, phenothiazines, retinoids, sulphonylureas, quinine and St John’s Wort 6. Also suffer from diseases where phototherapeutic treatment is contraindicated: xeroderma pigmentosum, lupus erythematosus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical markers and biomarkers as determinants of UVB phototherapy response for clinical application. Specific measures include: 1. Rate of apoptosis and biomarkers in skin biopsies taken after NbUVB phototherapy; rate of apoptosis is measured by manual and automated counts of histology slides at 24 hours after irradiation with narrowband UVB light (day 3) 2. Psoriasis severity measured using Psoriasis Area Severity Index (PASI) (score ranges: 0-72) at baseline, during phototherapy and at end of treatment. Follow- up by phone monthly for 6 months to assess length of remission | — |
Secondary
| Measure | Time frame |
|---|---|
| Integration of clinical and biomarker data using computer modelling to predict the outcome of UVB phototherapy in individual patients and develop personalised phototherapy regimes. Specific measures include: 1. Physician’s global assessment, demographics including assessment of handgrip strength, weight (kg), waist (cm), height (cm), blood pressure (mm/Hg) measured at baseline/within 6 months of recruitment 2. DNA and RNA extraction and analysis (serum isolation for sequencing and genotyping, reverse-transcriptase polymerase chain reaction (RT PCR), microarray transcriptome analysis, RNA sequencing, and epigenetic analysis), trace mineral and serological analysis, analysis of blood cell free DNA to look for DNA damage, all performed in blood samples collected at day 2, day 3, week 2, week 4 and week 8. These samples will enable assessment and refinement of potential biomarkers including but not limited to apoptotic biomarkers in blood/serum (fragmented cytokeratin-18, DNA nucleosomes, cytochrome c, serum fortilin, mtDNA (mtDNA) damage). These biomarkers will be quantified by ELISA, qPCR or similar techniques. 3. Mitochondrial DNA analysis of skin swab samples (non-invasive site-matched swab sampling will be collected from non-lesional plus lesional skin [ideally lower back] of psoriasis patients), measured at day 2, day 3, week 2, week 4 and week 8 4. Minimal erythema dose (skin’s sensitivity to narrowband UV light) measured visually with the aid of an erythema meter, in line with current clinical practice, at 24 hours after test irradiation and performed at baseline, week 2, week 4 and week 8 5. Impact of skin disease on quality of life measured using Dermatology Life Quality Index (DLQI) (score ranges: 0-30) at week 1 and week 8 | — |
Countries
United Kingdom
Outcome results
None listed