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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02518048
Other study ID # LP0053-1227
Secondary ID
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


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
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