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

Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin and Connective Tissue Diseases

Intervention: LP0113 aerosol spray (Drug); Aerosol spray vehicle (Drug); LEO 90100 aerosol foam (Drug); Betamethasone dipropionate aerosol spray (Drug); Calcipotriol aerosol spray (Drug); Daivobet® gel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: LEO Pharma

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration)

Secondary outcome:

Absolute change in single clinical sign score: erythema, scaling, infiltration

Absolute Change in Total Clinical Score (TCS)

Absolute change in total skin thickness and echo-poor band thickness

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

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

Starting date: April 2015
Last updated: July 21, 2015

Page last updated: August 23, 2015

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