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

LEO Pharma40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Psoriasis Vulgaris

Interventions

LEO 80190DRUG

Applied once daily

HydrocortisoneDRUG

Applied once daily

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Saint-Etienne Hôpital NOrd

Saint-Etienne, France

Outcomes

Primary Outcomes

The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment

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.

Time frame: From baseline (Day 0) to end of treatment (Week 8)

Secondary Outcomes

Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF

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.

Time frame: 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)

Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF

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.

Data from ClinicalTrials.gov

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