Phase 3
N=40
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
Psoriasis Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT01007591 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment — -60.8; -54.2 percentage of change in PASI — p=0.75
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LEO 80190 (Drug); Hydrocortisone (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment |
-60.8; -54.2 | 0.75 |
| SECONDARY Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF |
13; 7; 14; 6 | — |
| SECONDARY The Percentage Change in PASI of the Face LOCF at Week 4 |
-54.8; -54.9 | — |
| SECONDARY Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF |
2; 4; 5; 0 | — |
| SECONDARY The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF |
-56.6; -93.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01007591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.