A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris

Skin and Connective Tissue Diseases Clinical Trial

Official title:

A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LEO 90100 Aerosol Foam Compared to Betesil® Medicated Plaster in the Treatment of Psoriasis Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518048
• Other study ID #: LP0053-1227
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2015
• Last updated: March 3, 2016
• Start date: August 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster

Description:

The products will be applied on 6 test sites (each product on 3 test sites) once daily 6 days a week (except Sundays) for 4 weeks. The application sites for each product will be determined according to random assignment. Depending on the size of the psoriasis plaques, 2 or 4 test sites will be located within the same plaque; the treatment assignment will be done pair-wise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• 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 preferably three lesions (plaques) located on arms, legs and/or trunk or at least two lesions (plaques) located on arms, legs and/or trunk. For subjects with three lesions, each lesion must have a size suitable to accommodate 2 test sites (test site area 5 cm2, distance between two test sites at least 2 cm). For subjects with two lesions, one lesion must have a size suitable to accommodate 4 test sites, and the other lesion must accommodate 2 test sites.

• 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 Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• LEO 90100 Aerosol foam

• Betesil® 2.25 mg

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	No
Secondary	Absolute change in score of each clinical sign: erythema, scaling, infiltration		End of treatment and at individual visits compared to baseline - 4 weeks	No
Secondary	Absolute Change in Total Clinical Score (TCS)		Individual visits compared to baseline - 4 weeks	No
Secondary	Absolute change in total skin thickness and echo-poor band thickness		End of treatment compared to baseline - 4 weeks	No