A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products
NCT ID: NCT00875277
Last Updated: 2025-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2009-04-30
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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LEO 29102 cream
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks
LEO 29102 cream
LEO 29102 Cream Vehicle
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
LEO 29102 Cream Vehicle
Betamethasone Dipropionate Cream
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
Betamethasone Dipropionate Cream
LEO 29102 Plus Calcipotriol Cream
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
LEO 29102 Plus Calcipotriol Cream
LEO 29102 Plus Betamethasone Dipropionate
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
LEO 29102 Plus Betamethasone Dipropionate
Daivobet® Ointment
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
Daivobet® Ointment
Interventions
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LEO 29102 cream
LEO 29102 Cream Vehicle
Betamethasone Dipropionate Cream
LEO 29102 Plus Calcipotriol Cream
LEO 29102 Plus Betamethasone Dipropionate
Daivobet® Ointment
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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Director, International Clinical Development, MD
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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LEO Pharma site
Saint-Quentin-en-Yvelines, , France
Countries
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Other Identifiers
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PLQ-003
Identifier Type: -
Identifier Source: org_study_id
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