Antipsoriatic Effect of a Topical Formulation for the Treatment of Psoriasis Vulgaris
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Psoriasis Plaque Test SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment |
Drug: SPS4251 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)
Drug: Placebo
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)
Drug: Daivonex® 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).
Other Names:
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Outcome Measures
Primary Outcome Measures
- Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate [Up to Day 12]
Secondary Outcome Measures
- Evaluation of anti-psoriatic efficacy by clinical assessment [Up to day 12]
- Number of subjects with Adverse Events [Up to day 12]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
men aged 18 years or older
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subjects with mild to moderate psoriasis vulgaris in a chronic stable phase
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subject with up to three stable plaques with an area sufficient for five treatment fields
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Plaques to be treated should have a comparable thickness of the Echo Lucent Band of at least 200 µm
Exclusion Criteria:
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Subjects with guttate psoriasis, punctate psoriasis, erythrodermic psoriasis, psoriatic arthropathy and pustular psoriasis
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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
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Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids in the three months before first treatment and during the trial;
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Treatment with systemic medications or medications acting locally which might have countered or influenced the trial aim
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Contraindications according to summary of product characteristics of Daivonex® Ointment;
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UV-therapy within four weeks before first treatment and during the trial
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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
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Any history of cardiovascular disease
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Any evidence of ECG abnormality on screening ECG
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Close affiliation with the Investigator (e.g. a close relative) or persons working at bioskin GmbH or subject is an employee of the Sponsor;
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Subject is institutionalized because of legal or regulatory order.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bioskin | Berlin | Germany | ||
| 2 | Bioskin | Hamburg | Germany |
Sponsors and Collaborators
- Circassia Limited
- Bioskin GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SP001