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

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
SPS4251 Ointment
Placebo
Daivonex® ointment
Sponsored by
Circassia Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Bioskin
  • Bioskin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psoriasis Plaque Test

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of anti-psoriatic efficacy by clinical assessment
Number of subjects with Adverse Events

Full Information

First Posted
December 3, 2012
Last Updated
July 16, 2013
Sponsor
Circassia Limited
Collaborators
Bioskin GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01743118
Brief Title
Antipsoriatic Effect of a Topical Formulation for the Treatment of Psoriasis Vulgaris
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Circassia Limited
Collaborators
Bioskin GmbH

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psoriasis Plaque Test
Arm Type
Experimental
Arm Description
SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment
Intervention Type
Drug
Intervention Name(s)
SPS4251 Ointment
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Daivonex® ointment
Other Intervention Name(s)
calcipotriol
Intervention Description
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).
Primary Outcome Measure Information:
Title
Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate
Time Frame
Up to Day 12
Secondary Outcome Measure Information:
Title
Evaluation of anti-psoriatic efficacy by clinical assessment
Time Frame
Up to day 12
Title
Number of subjects with Adverse Events
Time Frame
Up to day 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Bioskin
City
Berlin
Country
Germany
Facility Name
Bioskin
City
Hamburg
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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