A Study Comparing LEO 80190 Ointment With Hydrocortisone Ointment, Both Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and Intertriginous Areas

February 21, 2025 updated by: LEO Pharma

Calcipotriol Plus Hydrocortisone in Paediatric Patients (Aged 6 to 17 Years) With Psoriasis Vulgaris on the Face and on the Intertriginous Areas

An international, multi-centre, prospective, randomised, double-blind, active-controlled, 2-arm, parallel group, 8-week, phase 3 clinical study in paediatric patients (aged 6 to 17 years) with psoriasis vulgaris on the face and on the intertriginous areas

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • CHU Saint-Etienne Hôpital NOrd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of psoriasis vulgaris involving the face
  • Clinical signs of psoriasis vulgaris on the trunk and/or on the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or limbs. The extent and severity of psoriasis vulgaris on trunk and/or limbs should be amenable to topical therapy with any of the allowed medications
  • An extent of psoriatic involvement of the face of at least 5 cm2 (the sum of all facial lesions)
  • Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 30 g (6 to 11 years) or 45 g (12 to 17 years) of ointment per week
  • Disease severity graded as mild, moderate or severe according to the investigator's global assessment of disease severity of the face
  • Aged 6 to 17 years

Exclusion Criteria:

  • Systemic treatment with therapies other than biologicals with a potential effect on psoriasis vulgaris within the 4-week period prior to randomisation
  • 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
  • PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
  • UVB therapy within the 2-week period prior to randomisation
  • Topical treatment of psoriasis vulgaris lesions on the face or on the intertriginous areas within the 2-week period prior to randomisation
  • Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
  • Initiation of or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the treatment phase of the study
  • Current diagnosis of erythrodermic, exfoliative or pustular psoriasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: LEO 80190 ointment
Drug: LEO 80190
Applied once daily
Active Comparator: Hydrocortisone 10 mg/g ointment
Drug: Hydrocortisone
Applied once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment
Time Frame: From baseline (Day 0) to end of treatment (Week 8)

PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula:

0.05 (R+T+S) E

It ranged from 0 to 3.6.
From baseline (Day 0) to end of treatment (Week 8)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF
Time Frame: At end of treatment (Week 8)

For subjects with a baseline (Day 0) severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of the face.

For subjects with a baseline (Day 0) severity of mild - "controlled disease" of the face was defined as clear according to the IGA of the face.

At baseline (Day 0) to end of treatment (Week 8) the (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below.

Clear, almost clear, mild, moderate, severe and very severe.
At end of treatment (Week 8)
The Percentage Change in PASI of the Face LOCF at Week 4
Time Frame: From baseline (Day 0) to Week 4 (Day 28)

PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula:

0.05 (R+T+S) E It ranged from 0 to 3.6.
From baseline (Day 0) to Week 4 (Day 28)
Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF
Time Frame: At end of treatment (Week 8)

At baseline (Day 0) to end of treatment (Week 8) the (sub)investigator made an assessment of the disease severity of the intertriginous areas using the following 6-category scale.

Clear, almost clear, mild, moderate, severe and very severe.

For subjects with a baseline (Day 0) severity of moderate or worse - "controlled disease" of the intertriginous areas was defined as clear or almost clear according to the IGA of the intertriginous areas.

For subjects with a baseline (Day 0) severity of mild - "controlled disease" of the intertriginous areas was defined as clear according to the IGA of the intertriginous areas.
At end of treatment (Week 8)
The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF
Time Frame: From baseline (Day 0) to end of treatment (Week 8)

For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the intertriginous areas was determined according to the scale below:

Redness 0.none

  1. mild
  2. moderate
  3. severe
  4. very severe

Thickness

0.none

  1. mild
  2. moderate
  3. severe
  4. very severe

Scaliness

0.none

  1. mild
  2. moderate
  3. severe
  4. very severe A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS ranging from 0 to 12.
From baseline (Day 0) to end of treatment (Week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LEO Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frédéric Cambazard, MD, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LEO 80190-O25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriasis Vulgaris

Clinical Trials on LEO 80190

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings