Phase 3
Completed 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
Source: ClinicalTrials.gov NCT01007591 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
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 | — |
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. Informational only — not medical advice.