Skip to main content
OpenTrials
Completed

NCT Number: NCT01007591

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Vulgaris

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Saint-Etienne Hôpital NOrd

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEO 80190

Drug

Applied once daily

Hydrocortisone

Drug

Applied once daily

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

    • mild
    • moderate
    • severe
    • very severe

    Thickness

    0.none

    • mild
    • moderate
    • severe
    • very severe

    Scaliness

    0.none

    • mild
    • moderate
    • severe
    • 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.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 4, 2009
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.