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

NCT ID: NCT01007591

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-12-31

Brief Summary

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

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LEO 80190 ointment

Group Type: ACTIVE_COMPARATOR

LEO 80190

Intervention Type: DRUG

Applied once daily

Hydrocortisone 10 mg/g ointment

Group Type: ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type: DRUG

Applied once daily

Interventions

LEO 80190

Applied once daily

Intervention Type: DRUG

Hydrocortisone

Applied once daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Cambazard, MD

Role: PRINCIPAL_INVESTIGATOR

FRANCE

Locations

CHU Saint-Etienne Hôpital NOrd

Saint-Etienne, , France

Countries

France

Other Identifiers

LEO 80190-O25

Identifier Type: -

Identifier Source: org_study_id