Antipsoriatic Effect of a Topical Formulation for the Treatment of Psoriasis Vulgaris

NCT01743118 | Completed Phase 1

• 1 other identifier: SP001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate

  Up to Day 12

Secondary Outcomes (2)

• Evaluation of anti-psoriatic efficacy by clinical assessment

  Up to day 12

• Number of subjects with Adverse Events

  Up to day 12

Study Arms (1)

Psoriasis Plaque Test

EXPERIMENTAL

SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment

Drug: SPS4251 Ointment; Drug: Placebo; Drug: Daivonex® ointment

Interventions

SPS4251 Ointment DRUG

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)

Psoriasis Plaque Test

Placebo DRUG

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)

Psoriasis Plaque Test

Daivonex® ointment DRUG

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).

Also known as: calcipotriol

Psoriasis Plaque Test

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Circassia Limited: lead
• Bioskin GmbH: collaborator

Study Sites (2)

Bioskin

Berlin, Germany

Location

Bioskin

Hamburg, Germany

Location

MeSH Terms

Interventions

calcipotriene

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 6, 2012
• Study Start: March 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 17, 2013

Record last verified: 2013-07

Locations

DE (2)