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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT01007591•LEO Pharma

View on ClinicalTrials.gov

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

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

October 1, 2009

Primary Completion Date

June 1, 2010

Completion Date

December 1, 2010

Last Updated

March 7, 2025

Enrollment

ACTUAL participants

Conditions

Psoriasis Vulgaris

Interventions

LEO 80190

DRUG

Hydrocortisone

DRUG

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

NCT04080635

Psoriasis Vulgaris

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COMPLETEDPHASE4

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

NCT04340076

PsoriasisPsoriasis Vulgaris

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WITHDRAWNNA

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP

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