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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01007591
First received: November 3, 2009
Last updated: October 25, 2013
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Psoriasis Vulgaris
Drug: LEO 80190
Drug: Hydrocortisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Calcipotriol Plus Hydrocortisone in Paediatric Patients (Aged 6 to 17 Years) With Psoriasis Vulgaris on the Face and on the Intertriginous Areas

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • The percentage change in PASI of the face from baseline to week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients with "controlled disease" according to the investigator's global assessment of disease severity on the face [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • The percentage change in PASI of the face from baseline to Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Patients with "controlled disease" according to the investigator's global assessment of disease severity of the intertriginous areas [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • The percentage change in Total Sign Score of the intertriginous areas from baseline to week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LEO 80190 ointment Drug: LEO 80190
Applied once daily
Active Comparator: Hydrocortisone 10 mg/g ointment Drug: Hydrocortisone
Applied once daily

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007591

Locations
France
CHU Saint-Etienne Hôpital NOrd
Saint-Etienne, France, 42055
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Frédéric Cambazard, MD FRANCE
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01007591     History of Changes
Other Study ID Numbers: LEO 80190-O25
Study First Received: November 3, 2009
Last Updated: October 25, 2013
Health Authority: Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014