A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123) (LP0113-1123)

A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LP0113 Aerosol Spray Compared With Its Vehicle and With Daivobet® Gel, LEO 90100 Aerosol Foam, Betamethasone Dipropionate Aerosol Spray and Calcipotriol Aerosol Spray in the Treatment of Psoriasis Vulgaris

The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.

Study Overview

• Status: Completed
• Conditions: Skin and Connective Tissue Diseases
• Intervention / Treatment: Drug: LEO 90100 aerosol foam; Drug: Aerosol spray vehicle; Drug: Betamethasone dipropionate aerosol spray; Drug: Calcipotriol aerosol spray; Drug: Daivobet® gel; Drug: LP0113 aerosol spray

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed and dated informed consent has been obtained
• Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products.
• Age 18 years or above
• Outpatients

• Female subjects must be of either

  • non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or,
  • child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.

Exclusion Criteria:

• Female subjects who are breast feeding

• Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

  • Etanercept - within 4 weeks prior to randomisation and during the trial
  • Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial
  • Ustekinumab - within 16 weeks prior to randomisation and during the trial
  • Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer)
• Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial,

• Subjects using phototherapy within the following time periods prior to randomisation and during the trial:

  • PUVA: 4 weeks
  • UVB: 2 weeks

• Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial:

  • Potent or very potent (WHO group III-IV) corticosteroids

• Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial:

  • WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
  • Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid
• Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial
• Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial
• Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LP0113 aerosol spray; Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical	Drug: LEO 90100 aerosol foam; Drug: Aerosol spray vehicle; Drug: Betamethasone dipropionate aerosol spray; Drug: Calcipotriol aerosol spray; Drug: Daivobet® gel
Placebo Comparator: Aerosol spray vehicle; No active ingredient, topical	Drug: LEO 90100 aerosol foam; Drug: Betamethasone dipropionate aerosol spray; Drug: Calcipotriol aerosol spray; Drug: Daivobet® gel; Drug: LP0113 aerosol spray
Active Comparator: LEO 90100 aerosol foam; Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical	Drug: Aerosol spray vehicle; Drug: Betamethasone dipropionate aerosol spray; Drug: Calcipotriol aerosol spray; Drug: Daivobet® gel; Drug: LP0113 aerosol spray
Active Comparator: Betamethasone dipropionate aerosol spray; Betamethasone (as dipropionate) 0.5 mg/g, topical	Drug: LEO 90100 aerosol foam; Drug: Aerosol spray vehicle; Drug: Calcipotriol aerosol spray; Drug: Daivobet® gel; Drug: LP0113 aerosol spray
Active Comparator: Calcipotriol aerosol spray; Calcipotriol (as monohydrate) 50 mcg/g, topical	Drug: LEO 90100 aerosol foam; Drug: Aerosol spray vehicle; Drug: Betamethasone dipropionate aerosol spray; Drug: Daivobet® gel; Drug: LP0113 aerosol spray
Active Comparator: Daivobet® gel; Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical	Drug: LEO 90100 aerosol foam; Drug: Aerosol spray vehicle; Drug: Betamethasone dipropionate aerosol spray; Drug: Calcipotriol aerosol spray; Drug: LP0113 aerosol spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration)	End of treatment compared to baseline - 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Absolute change in single clinical sign score: erythema, scaling, infiltration	End of treatment and individual visits compared to baseline - 4 weeks
Absolute Change in Total Clinical Score (TCS)	Individual visits compared to baseline - 4 weeks
Absolute change in total skin thickness and echo-poor band thickness	End of treatment compared to baseline - 4 weeks

Collaborators and Investigators

• Sponsor: LEO Pharma

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 13, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Connective Tissue Diseases; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
• Other Study ID Numbers: LP0113-1123; 2014-004759-30 (EudraCT Number)