The target of this study is to determine if blue light of 420 nm is effective against psoriasis
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The LPSI calculation method is used:
LPSI = erythema + scaling + induration
The sum of the scaling, erythema and plaque elevation (induration) gives rise
to the LPSI score (0 to 12). Patients with a LPSI score of the target lesion
5 at Baseline/Visit Day 1 may be included in the trial.
The patients will be visited at the:
- Screening
- Baseline (beginning of week 1)
- Beginning of week 3
- End of week 4 + 1 (working) day
At each visit possible adverse events, like pigmentation and/or erythema (in a
scale from 0 to 4) will be notified.
At Baseline, beginning of week 3 and end of week 4 +1 (working) day a picture
will be taken.
Secondary outcome
N.v.t.
Background summary
Psoriasis is a not contagious skin disorder characterized by red and scaled
plaques, which can occur on the whole body. Often this disorder is hereditary.
Psoriasis can be improved very much with treatment, but no therapy can cure
this skin disease definitely.
Psoriasis is characterized by an accelerated cell division in the epidermis and
by inflammation symptoms in the epidermis and dermis.
The precise cause is not known, but genetic predisposition is very important.
In people with this predisposition different factors make psoriasis break out.
Examples of these are damage of the skin, infections, use of medicines and
psychological stress.
Psoriasis can start at any age. The most occurring form of psoriasis is called
plaque psoriasis, being the characteristics red scaled plaques sharply
delimited. The plaques vary in size and can come together forming bigger
plaques with different shapes. The psoriasis plaques can appear anywhere in the
body, but especially on elbows and knees, the head with hair, and the back. On
the palms and soles the psoriasis can be coupled to painful cleaves.
Study objective
The target of this study is to determine if blue light of 420 nm is effective
against psoriasis
Study design
Patients are included after checking the inclusion and exclusion criteria and
signing an informed consent
Every Friday, Saturday and Sunday the plaques are treated with Salicylic acid
10% in petrolatum in order to remove excessive scaling and on Monday the
patient will start/continue the treatment with blue light.
Previous to every light treatment the two plaques to be treated will be wetted
with water.
Irradiation (at the distance of few centimeters from the plaque)
20 patients get 20 min treatment 3x week, for 4 weeks, ~90 mW/cm2 with the real
device (LED*s based blue light 420 nm) on one plaque, and ~90 mW/cm2 with the
placebo device (LED*s based red light 630 nm) on the other plaque.
Intervention
N.v.t.
Study burden and risks
Blue light belongs to the spectrum of visible light. Based on the wavelength
and intensity used in this study the chance of side effects is limited to a
possible slight and temporary erythema. Because no UV radiation is emitted, the
chance of side effects as effect of UV radiation (premature aging, skin cancer)
is considered negligible
Polikliniek Dermatologie Radboud west René Descartesdreef 1
6500 HB Nijmegen
Nederland
Polikliniek Dermatologie Radboud west René Descartesdreef 1
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
· Male or female patients, 18 years or older.
· Patient suffering from plaque psoriasis demonstrated through documentation in their medical history for at least 6 months.
· Current stable disease for at least 6 months as documented in medical notes
· Patient has a total psoriasis affected Body Surface Area (BSA)< 10%
· Two target lesion, symmetrically localized, with the following criteria;
o Located on the trunk or extremities (excluding the extension surface of the elbows and knees, hands, feet, groin, scalp and genital areas)
o Size of approximately 4 cm in diameter
o LPSI score> 5
· Patient agrees to comply with the study requirements and attend all required visits.
· No concomitant light treatment including sunbathing or use of commercial sun beds.
· Patients must be capable of understanding the purpose and the risk of the trial, and have given written, informed consent
· Patient meets the concomitant medication washout requirements as indicated in the protocol (pag. 4) and agrees to follow restrictions during the study
Exclusion criteria
- Patients with very severe scales (Scaling 4)
- Patient has a skin disorder other than plaque or patch psoriasis in the areas to be treated. This includes, but is not limited to, pustular psoriasis, erythrodermic psoriasis, guttate psoriasis, or a cutaneous infection
- Patient has a knows diagnosis or history of cancer or HIV
- Patient has a medical condition or disorder that, in the opinion of the investigator, precludes the patient from participating in the study
- Patient is pregnant or breast feeding an infant
- Current or participation in the previous 28 days in another clinical trial of any sort
- Patient with known, documented history of alcohol or drug abuse
- Patient with target lesions located on the head, hands, extension sites of elbows and knees, feet or genitalia.
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 | NL20950.091.07 |