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 Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Nice, France
    • LEO Pharma site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Calcipotriol ointment	Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues; Once daily application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Clinical Score of clinical symptoms	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical scores, lesions thickness	4 weeks

Collaborators and Investigators

• Sponsor: LEO Pharma

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (ESTIMATE): April 16, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 25, 2013
• Last Update Submitted That Met QC Criteria: October 24, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Dermatologic Agents; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D; Calcipotriene
• Other Study ID Numbers: PLQ-005; 2009-017393-20 (EUDRACT_NUMBER)