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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014