A Psoriasis Plaque Test Comparing Products for the Treatment of Psoriasis Vulgaris

NCT01043224 | Completed Phase 1

• 2 other identifiers: PLQ-004EudractCT No: 2009-012139-14
• 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 a topical combination product containing clobetasol propionate and calcipotriol in an ointment formulation to the single components in the same vehicle using a psoriasis plaque test design.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Total Clinical Score of clinical symptoms

  3 weeks

Secondary Outcomes (1)

• Clinical scores, lesions thickness, NIR spectroscopic measurements

  3 weeks

Study Arms (1)

Clobetasol propionate plus calcipotriol

EXPERIMENTAL

Drug: Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicle

Interventions

Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicle DRUG

Once daily application

Clobetasol propionate plus calcipotriol

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 (ustekinmab) 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
• 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 2 weeks prior to randomisation
• WHO group I-II corticosteroids
• 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, 06202, France

Location

Study Officials

• Patrice Facy, PhD

  LEO Pharma

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 6, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 24, 2025

Record last verified: 2013-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)