Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis

Launched by LEO PHARMA · Sep 15, 2005

Keywords

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Eligibility criteria

• Inclusion Criteria:
• • Scalp psoriasis amenable to topical treatment with a maximum of 100 g of study medication per week
• • Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
• • Extent of scalp psoriasis involving more than 10% of the total scalp area
• • Disease severity on the scalp graded as Moderate, Severe or Very Severe according to the Investigator's Global Assessment of disease severity
• Exclusion Criteria:
• • PUVA or Grenz ray therapy anywhere on the patient within 28 days prior to randomisation
• • UVB therapy anywhere on the patient within 14 days prior to randomisation
• • Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on, scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisaiton
• • Systemic treatments with a potential effect on scalp psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 28 days prior to randomisation
• • Any topical treatment for scalp psoriasis or any other skin disease on the scalp (excluding medicated shampoos, emollients and hair conditioners) within 14 days prior to randomisaiton
• • Topical treatment for other skin disorders with very potent WHO group IV corticosteroids within 14 days prior to randomisation
• • Planned initiation of, or changes in dose of concomitant medication that could affect scalp psoriasis (e.g., beta blockers, antimalarial drugs, lithium) during the study
• • Current diagnosis of guttate, pustular, exfoliative or erythrodermic psoriasis
• • Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin
• • Known or suspected severe renal insufficiency or severe hepatic disorders
• • Patiens with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
• • Trial subjects should be using an adequate method of contraception