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

Skin and Connective Tissue Diseases Clinical Trial

— LP0113-1123  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416258
• Other study ID #: LP0113-1123
• Secondary ID: 2014-004759-30
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2015
• Last updated: May 1, 2017
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: May 2017
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Psoriasis
• Skin and Connective Tissue Diseases

Intervention

Drug:
• LP0113 aerosol spray

• Aerosol spray vehicle

• LEO 90100 aerosol foam

• Betamethasone dipropionate aerosol spray

• Calcipotriol aerosol spray

• Daivobet® gel

Locations

Country	Name	City	State
France	Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)	Nice

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

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

External Links

•   Clinical Trials at LEO Pharma