Plaque Psoriasis Psoriasis
Conditions
Interventions
N.v.t.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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) 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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| N.v.t. | — |
Countries
Netherlands
Outcome results
None listed