To ascertain the amount of UV-damage (p53 activation, apoptosis, thymidine dimers and γH2AX) is caused by the Dermasun treatment in psoriasis patients.Total skin check in patients using Dermasun for a prolonged period of time to screen for…
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To ascertain the amount of UV-damage (p53 activation, thymidine dimers,
apoptosis and γH2AX) is caused by the Dermasun treatment in psoriasis patients
in comparison to conventional smallspectrum UV-treatment and no UV treatment.
Secondary outcome
Number of (pre-) cancerous skin lesions found at the biopsy time point
Reported actual use of Dermasun by patients after having Dermasun in their
homes for at least a year.
Background summary
Several forms of phototherapy are available to psoriasis patients: narrowband
UVB thrice weekly is the standard treatment. Recently we performed a study to
assess the effectivity of a daily low emission phototherapy device (DermaSun
Medical). Preliminary findings during the first few months of treatment showed
no carcinogenic effects.
This treatment modality is used at home, and patients can use this device at
their own volition.
Since, this device has been used in a larger number of patients (over 200) for
several consecutive years. To ascertain the long term effects of treatment with
this home based device an additional study is needed.
Study objective
To ascertain the amount of UV-damage (p53 activation, apoptosis, thymidine
dimers and γH2AX) is caused by the Dermasun treatment in psoriasis patients.
Total skin check in patients using Dermasun for a prolonged period of time to
screen for (pre-) cancerous skin lesions
Check what actual usage of the Dermasun retrospectively is in patients when it
is readily available to patients on a daily basis
Study design
The study is an observational cross-sectional cohort study. Three cohorts of
psoriasis patients will be analysed:
• using Dermasun treatment for a prolonged period of time;
• undergoing conventional narrowband UVB treatment
• not undergoing UV-treatment (yet)
The study has one timepoint where measurement will be performed.
The analysis of the actual use of the Dermasun in patients in cohort is a
retrospective study part.
Study burden and risks
Patients will be asked to perform one out-patient visit to the dermatology
clinic. Two 4 mm skin biopsies will be taken, preferably from the buttocks
region. Skin biopsies usually heal without scarring.
Hoogoorddreef 63-65
Amsterdam 1101BB
NL
Hoogoorddreef 63-65
Amsterdam 1101BB
NL
Listed location countries
Age
Inclusion criteria
>18 years old
psoriasis;Depending on the research arm:
- undergoing conventional phototherapy for at least 4 weken
- undergoing low emission phototherapy for at least 18 maanden
- not undergoing phototherapy or any systemic treatment for psoriasis
Exclusion criteria
systemic medication for treatment of psoriasis
unable to give informed consent
Design
Recruitment
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 | NL66853.029.18 |