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
The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) | Nice |
Lead Sponsor | Collaborator |
---|---|
LEO Pharma |
France,
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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