ID

11638

Description

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis ODM derived from http://clinicaltrials.gov/ct2/show/NCT00148213?term=NCT00148213&rank=1

Link

http://clinicaltrials.gov/ct2/show/NCT00148213?term=NCT00148213&rank=1

Keywords

Versions (2)
  1. 11/24/11 11/24/11 -
  2. 7/9/15 7/9/15 - Martin Dugas
Uploaded on

July 9, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Psoriasis NCT00216879

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Details

Eligibility Psoriasis NCT00216879

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  1. StudyEvent: Eligibility
    1. Eligibility Psoriasis NCT00216879
Inclusion Criteria
18 Years and older
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
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