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

NCT01007591 | Completed Phase 3 Results DMC

• 1 other identifier: LEO 80190-O25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF

  At end of treatment (Week 8)

• The Percentage Change in PASI of the Face LOCF at Week 4

  From baseline (Day 0) to Week 4 (Day 28)

• Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF

  At end of treatment (Week 8)

• The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF

  From baseline (Day 0) to end of treatment (Week 8)

Study Arms (2)

LEO 80190 ointment

ACTIVE COMPARATOR

Drug: LEO 80190

Hydrocortisone 10 mg/g ointment

ACTIVE COMPARATOR

Drug: Hydrocortisone

Interventions

LEO 80190 DRUG

Applied once daily

LEO 80190 ointment

Hydrocortisone DRUG

Applied once daily

Hydrocortisone 10 mg/g ointment

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

CHU Saint-Etienne Hôpital NOrd

Saint-Etienne, 42055, France

Location

MeSH Terms

Interventions

Hydrocortisone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Frédéric Cambazard, MD

  FRANCE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 7, 2025
• Results First Posted: January 15, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)