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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on September 16, 2014