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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01105286
First received: April 15, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Psoriasis Vulgaris
Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Total Clinical Score of clinical symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical scores, lesions thickness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcipotriol ointment Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues
Once daily application

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105286

Locations
France
LEO Pharma site
Nice, France
Sponsors and Collaborators
LEO Pharma
Investigators
Study Director: Patrice Facy, PhD LEO Pharma
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01105286     History of Changes
Other Study ID Numbers: PLQ-005, 2009-017393-20
Study First Received: April 15, 2010
Last Updated: October 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Vitamin D
Ergocalciferols
Vitamins
Calcipotriene
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014