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 Clinical Trial

Official title:

Calcipotriol Plus Hydrocortisone in Paediatric Patients (Aged 6 to 17 Years) With Psoriasis Vulgaris on the Face and on the Intertriginous Areas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007591
• Other study ID #: LEO 80190-O25
• Status: Completed
• Phase: Phase 3
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2018
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• LEO 80190
Applied once daily
• Hydrocortisone
Applied once daily

Locations

Country	Name	City	State
France	CHU Saint-Etienne Hôpital NOrd	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment	PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula: 0.05 (R+T+S) E; It ranged from 0 to 3.6.	From baseline (Day 0) to end of treatment (Week 8)
Secondary	Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF	For subjects with a baseline (Day 0) severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of the face.; For subjects with a baseline (Day 0) severity of mild - "controlled disease" of the face was defined as clear according to the IGA of the face.; At baseline (Day 0) to end of treatment (Week 8) the (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below.; Clear, almost clear, mild, moderate, severe and very severe.	At end of treatment (Week 8)
Secondary	The Percentage Change in PASI of the Face LOCF at Week 4	PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula: 0.05 (R+T+S) E It ranged from 0 to 3.6.	From baseline (Day 0) to Week 4 (Day 28)
Secondary	Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF	At baseline (Day 0) to end of treatment (Week 8) the (sub)investigator made an assessment of the disease severity of the intertriginous areas using the following 6-category scale.; Clear, almost clear, mild, moderate, severe and very severe.; For subjects with a baseline (Day 0) severity of moderate or worse - "controlled disease" of the intertriginous areas was defined as clear or almost clear according to the IGA of the intertriginous areas.; For subjects with a baseline (Day 0) severity of mild - "controlled disease" of the intertriginous areas was defined as clear according to the IGA of the intertriginous areas.	At end of treatment (Week 8)
Secondary	The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF	For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the intertriginous areas was determined according to the scale below: Redness 0.none; mild; moderate; severe; very severe; Thickness; 0.none; mild; moderate; severe; very severe; Scaliness; 0.none; mild; moderate; severe; very severe A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS ranging from 0 to 12.	From baseline (Day 0) to end of treatment (Week 8)