Assessing the value of SunshowerMedical Helios as a at home maintenance treatment for patients with psoriasis vulgaris.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PASI-, Skindex-29 and DLQI-scores and their differences between groups.
Secondary outcome
Secondary study parameters:
Difference between control group and patients undergoing the home UV-treatment
in:
- serum levels of 25(OH)D3
- presence of pyrimidine dimers and/or p53-expression in epidermal cells of
patients
- amount of mometason ointment used
- parameters for metabolic syndrome (HbA1c, blood pressure)
Background summary
Psoriasis vulgaris is a common, cosmetically debilitating disease of the skin.
It is associated with arthritis and recently has been linked to higher risk for
developing metabolic syndrome. Patients are treated in different manners, i.e.
local corticosteroids, systemic immunosuppressants and phototherapy. This last
therapy is usually given during relapses as higher dose of UV is given to
patients. The effect of low dose continual UV-therapy is however not yet
elucidated. With the introduction of SunshowerMedical Helios on the Dutch
market, daily low dose, home phototherapy has become an practical and realistic
option.
As vitamin D is stimulated by UV exposure and this vitamin is possibly also
linked to metabolic syndrome, monitoring the parameters for metabolic syndrome
might prove interesting.
Study objective
Assessing the value of SunshowerMedical Helios as a at home maintenance
treatment for patients with psoriasis vulgaris.
Study design
open, controlled (randomised) intervention study
Intervention
Psoriasis patients will be randomised in a control group or for daily use of a
home UV-device, the Sunshower medical. Patients will be monitored in their
PASI-score, quality of life, vitamin D status, blood pressure and UV damage
caused by this device.
A group of 7 patients undergoing conventional TL01 UVB light therapy (group C)
will also be asked permission to retrieve two skin biopsies to assess the
amount of `normal` DNA damage caused by conventional UV-therapy. These patients
will not participate in other aspects of the study and no extra out-patient
clinic visits will be needed.
Study burden and risks
Patient visits: 3 after informed consent
Questionnaires: 3x 2 questionnaires (total 40 questions)
Physical examinations : 4x (skin only), 2x weight assessment, 2x blood pressure
Venapunction: 3x 1 blood sample for half of included patients
Skin biopsy 3mm: 2x for 12.5% of patients, usually heals without scarring + 7
patients (group C) undergoing conventional phototherapy (higher dose) and in no
other way will be asked to participate in this study.
The risk associated with participation is negligible as the amount of UV that
is used in this study is significantly lower than daily, maximum advised dose.
It is already good clinical practice to treat (psoriasis) patient with
UV-devices with a much higher dose.
For the patients in group C, a minimal risk of scarring is associated with skin
biopsies.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
* Psoriasis vulgaris diagnosed by a dermatologist
* 18 years or above
* Informed consent
* Patients successfully treated with phototherapy (UVB/TL01) OR after successful local therapy and a history of good clearance after UV/exposure.
Exclusion criteria
* Use of fumaric acid or immunosuppressants now or in the 2 months previous to inclusion.
* Active psoriatic arthritis
* History of skin cancer
* Concurrent photosensitive skin disorders
* Planned sunny holidays during the trial
* Use of tanning booths (at home or tanning studio)
* Use of vitamine D supplement
* Pregnancy or actively planning to get pregnant
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL37130.029.11 |