Clinical trial NCT01007591: 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
Official title: Calcipotriol Plus Hydrocortisone in Paediatric Patients (Aged 6 to 17 Years) With Psoriasis Vulgaris on the Face and on the Intertriginous Areas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2009-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment
timeFrame: From baseline (Day 0) to end of treatment (Week 8)
Secondary outcomes:
measure: Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF
timeFrame: At end of treatment (Week 8)
measure: The Percentage Change in PASI of the Face LOCF at Week 4
timeFrame: From baseline (Day 0) to Week 4 (Day 28)
measure: Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF
timeFrame: At end of treatment (Week 8)
measure: The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF
timeFrame: From baseline (Day 0) to end of treatment (Week 8)
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne Hôpital NOrd
Study officials:
affiliation: FRANCE
name: Frédéric Cambazard, MD
role: PRINCIPAL_INVESTIGATOR
References: