A Plaque Test Comparing the Anti-psoriatic Effect of Marketed Products for Topical Use for Psoriasis Vulgaris
NCT ID: NCT00845481
Last Updated: 2025-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2009-01-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
SINGLE
Study Groups
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all patients apply all products
Daivobet® ointment
Once daily application 6 days a week for 3 weeks
Betnovat® ointment
Once daily application 6 days a week for 3 weeks
Diprosalic ointment
Once daily application 6 days a week for 3 weeks
Dermovat ointment
Once daily application 6 days a week for 3 weeks
Elocon ointment
Once daily application 6 days a week for 3 weeks
Daivobet® ointment vehicle
Once daily application 6 days a week for 3 weeks
Interventions
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Daivobet® ointment
Once daily application 6 days a week for 3 weeks
Betnovat® ointment
Once daily application 6 days a week for 3 weeks
Diprosalic ointment
Once daily application 6 days a week for 3 weeks
Dermovat ointment
Once daily application 6 days a week for 3 weeks
Elocon ointment
Once daily application 6 days a week for 3 weeks
Daivobet® ointment vehicle
Once daily application 6 days a week for 3 weeks
Eligibility Criteria
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Inclusion Criteria
* All skin types
* Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable
* Subjects willing and able to follow all the study procedures and complete the whole study
* Subjects affiliated to social security system
Exclusion Criteria
* Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration
* Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
* Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - Potent or very potent (WHO group III-IV) corticosteroids - PUVA or Grenz ray therapy
* Subjects using one of the following topical drugs for the treatment of psoriasis within two (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy
* Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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LEO Pharma Investigational Site
Saint Quentin Yvelines Cedex, , France
Countries
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Related Links
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Clinical Trials at LEO Pharma
Other Identifiers
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PLQ-002
Identifier Type: -
Identifier Source: org_study_id
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