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

This study has been completed.
Sponsor:
Collaborator:
Bioskin GmbH
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01743118
First received: December 3, 2012
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Psoriasis Vulgaris
Drug: SPS4251 Ointment
Drug: Placebo
Drug: Daivonex® ointment
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase Ib, Two-centre, Randomised, Observer-blind, Placebo- and Comparator Controlled Trial to Evaluate the Safety, Tolerability and Antipsoriatic Efficacy of Three Strengths of a Topical SPS4251 Formulation in a Psoriasis Plaque Test

Resource links provided by NLM:


Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate [ Time Frame: Up to Day 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of anti-psoriatic efficacy by clinical assessment [ Time Frame: Up to day 12 ] [ Designated as safety issue: No ]
  • Number of subjects with Adverse Events [ Time Frame: Up to day 12 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: March 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: calcipotriol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743118

Locations
Germany
Bioskin
Berlin, Germany
Bioskin
Hamburg, Germany
Sponsors and Collaborators
Circassia Limited
Bioskin GmbH
  More Information

No publications provided

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01743118     History of Changes
Other Study ID Numbers: SP001
Study First Received: December 3, 2012
Last Updated: July 16, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014