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


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


  • 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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.