This project aims to assess the effect of laser therapy on the blood vessels and (peripheral) innervation of psoriasis plaques. The primary objective is to quantify the regression and recovery of nerves compared to blood vessels. We hypothesize that…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the difference in ratio between linear nerve
density to linear blood vessel density between the pre-treatment, and
post-treatment biopsies. This will be named the recovery ratio (nerves/blood
vessels). The tested hypothesis is that laser therapy results in a decrease in
nerve fibre density.
Secondary outcome
The secondary objective is to assess any relationship between the dermal
architecture (in terms of blood vessels and nerves) and leukocyte infiltration
before and after SPT treatment.
Background summary
Vascular laser therapy for psoriasis seems to achieve a remarkably long
treatment-free duration of remission. But why would sub-second heating of the
blood vessels of the skin result in a year-long resolution of an infamously
stubborn condition? The only other situation in which such long term clearance
is observed is in patients that experience significant damage to the
innervation, such as paraplegia. Even then the duration of remission is
correlated with the persistence of the injury. Fortunately laser therapy is not
associated with permanent nerve damage, but it does raise the question if it is
through an effect on the local innvervation that laser therapy results in a
cessation of the inflammation.
Unraveling the mechanism of action of laser therapy would not only allow for
the improvement of existing laser therapy protocols but also, could open the
door to a whole new range of interventions offering quasi-permanent solutions
for patients. There is a high need for such enduring therapies: Psoriasis is
both, a common and a costly skin condition. It affects between 1% and 9% of the
population and has a very severe impact on the quality of life of the patient.
It's chronic character implies lifelong treatment, and the associated risks and
effort.
Study objective
This project aims to assess the effect of laser therapy on the blood vessels
and (peripheral) innervation of psoriasis plaques. The primary objective is to
quantify the regression and recovery of nerves compared to blood vessels. We
hypothesize that the recovery of nerves after SPT is decreased compared to the
recovery of blood vessels.
Study design
Randomized single blinded intra patient comparative study.
Intervention
Patients undergo regular 595 nm pulsed dye laser therapy for psoriasis. Tissue
samples will be collected from the patients using a total of two 3 mm
punch-biopsies under local anesthesia. These samples are used to determine the
nerve density and blood vessel density in the treated and non-treated lesions.
Study burden and risks
During standard laser treatment for psoriasis, two tissue samples will be
acquired using 3 mm punch biopsies. As a consequence, two small permanent scars
(2x 7mm^2) are infliced upon the patients. The study is not expected to involve
significant risks or benefits compared to standard dermatological treatments
for psoriasis.
Hoge Naarderweg 3 F
Hilversum 1217AB
NL
Hoge Naarderweg 3 F
Hilversum 1217AB
NL
Listed location countries
Age
Inclusion criteria
18 - 69 years of age
- Psoriasis vulgaris
- Skin type I - III
- At least two lesions with of surface area of 3 cm2
- Contralateral psoriasis vulgaris lesions located on at least one of the
following locations:
* trunk
* upper arms
* upper legs
Exclusion criteria
The participant receives other treatments for psoriasis or affecting during the
study or two weeks before the start of the study
The participant suffers from any known neurological, vascular, or immunological
condition other than psoriasis.
The participant is allergic to lidocain
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 | NL75576.100.20 |