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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01007591
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : October 28, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: LEO 80190 Drug: Hydrocortisone Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2009
Primary Completion Date : June 2010
Study Completion Date : December 2010


Arms and Interventions

Arm Intervention/treatment
Active Comparator: LEO 80190 ointment Drug: LEO 80190
Applied once daily
Active Comparator: Hydrocortisone 10 mg/g ointment Drug: Hydrocortisone
Applied once daily


Outcome Measures

Primary Outcome Measures :
  1. The percentage change in PASI of the face from baseline to week 8 [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Patients with "controlled disease" according to the investigator's global assessment of disease severity on the face [ Time Frame: Week 8 ]
  2. The percentage change in PASI of the face from baseline to Week 4 [ Time Frame: Week 4 ]
  3. Patients with "controlled disease" according to the investigator's global assessment of disease severity of the intertriginous areas [ Time Frame: Week 8 ]
  4. The percentage change in Total Sign Score of the intertriginous areas from baseline to week 8 [ Time Frame: Week 8 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007591


Locations
France
CHU Saint-Etienne Hôpital NOrd
Saint-Etienne, France, 42055
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Frédéric Cambazard, MD FRANCE
More Information

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01007591     History of Changes
Other Study ID Numbers: LEO 80190-O25
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: December 2010

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents