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OpenTrials
Completed

NCT Number: NCT01105286

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

LEO Pharma investigational site

Nice, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues

Drug

Once daily application

Primary outcomes

  1. Total Clinical Score of clinical symptoms

    Time frame: 4 weeks

Secondary outcomes

  1. Clinical scores, lesions thickness

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 16, 2010
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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