A Psoriasis Plaque Test Comparing Eight Different Formulations of Vitamin D Analogues for the Treatment of Psoriasis

Overview

The purpose of this trial is to compare the anti-psoriatic effect of eight different formulations of vitamin D analogues using a psoriasis plaque test design

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: May 2010

Interventions

  • Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues
    • Once daily application

Arms, Groups and Cohorts

  • Experimental: Calcipotriol ointment

Clinical Trial Outcome Measures

Primary Measures

  • Total Clinical Score of clinical symptoms
    • Time Frame: 4 weeks

Secondary Measures

  • Clinical scores, lesions thickness
    • Time Frame: 4 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects having understood and signed an informed consent form.
  • Either sex
  • Age 18 years or above
  • All skin types and any ethnic origin
  • Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk.

Exclusion Criteria

  • Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
  • Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation
  • Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immuno-suppressants) within the 4-week period prior to randomisation
  • Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:
  • Potent or very potent (WHO group III-IV) corticosteroids
  • PUVA or Grenz ray therapy
  • Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:
  • WHO group I-II corticosteroids (except if used for treatment of scalp psoriasis)
  • Topical retinoids
  • Vitamin D analogues
  • Topical immunomodulators (e.g. macrolides)
  • Anthracen derivatives
  • Tar
  • Salicylic acid
  • UVB therapy
  • Subjects known to be non-responder to topical vitamin D analogues (e.g., known history of no improvement or worsening of psoriasis with e.g., calcipotriol, calcitriol or tacalcitol when used according to current SmPc)
  • Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
  • Subjects with current participation in any other interventional clinical, based on interview of the subject
  • Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
  • Subjects with known or suspected hypersensitivity to component(s) of the investigational products
  • Subjects with known/suspected disorders of calcium metabolism associated with hypercalcaemia
  • Subjects with known severe hepatic and/or severe renal insufficiency
  • Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LEO Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patrice Facy, PhD, Study Director, LEO Pharma

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