Status:
COMPLETED
A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products
Lead Sponsor:
LEO Pharma
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.
Eligibility Criteria
Inclusion
- (in summary)
- Subjects having understood and signed an informed consent form
- 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
- (in summary)
- Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00875277
Start Date
April 1 2009
End Date
July 1 2009
Last Update
March 12 2025
Active Locations (1)
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1
LEO Pharma site
Saint-Quentin-en-Yvelines, France