Psoriasis Vulgaris
Conditions
Brief summary
The current most important topical treatments for psoriasis are vitamin D3 analogues and/or corticosteroids. The possibility of another effective treatment for psoriasis could be based on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel. The aim of the clinical trial is to evaluate the safety, tolerability and anti-psoriatic efficacy of topical SPS4251 formulations in comparison to placebo and to a marketed topical Vitamin-D analogue ointment in a psoriasis plaque test.
Interventions
DRUGSPS4251 Ointment
Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments)
DRUGPlacebo
Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments)
Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments).
Sponsors
Bioskin GmbH
Circassia Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* men aged 18 years or older * subjects with mild to moderate psoriasis vulgaris in a chronic stable phase * subject with up to three stable plaques with an area sufficient for five treatment fields * Plaques to be treated should have a comparable thickness of the Echo Lucent Band of at least 200 µm
Exclusion criteria
* Subjects with guttate psoriasis, punctate psoriasis, erythrodermic psoriasis, psoriatic arthropathy and pustular psoriasis * Local treatment with antipsoriatics in the 4 weeks preceding and/or during the trial, and any topical antipsoriatic treatment on the plaques to be treated in this trial in the 8 weeks before first treatment and/or during the trial * Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids in the three months before first treatment and during the trial; * Treatment with systemic medications or medications acting locally which might have countered or influenced the trial aim * Contraindications according to summary of product characteristics of Daivonex® Ointment; * UV-therapy within four weeks before first treatment and during the trial * Symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before baseline visit and during the trial * Any history of cardiovascular disease * Any evidence of ECG abnormality on screening ECG * Close affiliation with the Investigator (e.g. a close relative) or persons working at bioskin GmbH or subject is an employee of the Sponsor; * Subject is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate | Up to Day 12 |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of anti-psoriatic efficacy by clinical assessment | Up to day 12 |
| Number of subjects with Adverse Events | Up to day 12 |
Countries
Germany
Outcome results
None listed