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

NCT01105286 | Completed Phase 1

• 2 other identifiers: PLQ-0052009-017393-20
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Total Clinical Score of clinical symptoms

  4 weeks

Secondary Outcomes (1)

• Clinical scores, lesions thickness

  4 weeks

Study Arms (1)

Calcipotriol ointment

EXPERIMENTAL

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

Interventions

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

Once daily application

Calcipotriol ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

LEO Pharma investigational site

Nice, France

Location

Study Officials

• Patrice Facy, PhD

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 16, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 24, 2025

Record last verified: 2013-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)