Trial | NCT00216840  Report issue

Title

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle and Calcipotriol in the Gel Vehicle in Scalp Psoriasis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1350
The purpose of the study is to evaluate whether once daily topical treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis.

The primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.
Study Started
Dec 31
2004
Study Completion
Sep 30
2005
Last Update
Mar 26
2015
Estimate

Drug Calcipotriol plus betamethasone dipropionate (LEO80185 gel)

Criteria 

Inclusion Criteria:

Scalp psoriasis amenable to topical treatment with a maximum of 100 g of 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
Investigator's assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, erythema, thickness and scaliness, and at least 1 in each of the other two clinical signs
Disease severity on the scalp graded as Mild, Moderate, Severe or Very severe according to the investigator's global assessment of disease severity

Exclusion Criteria:

PUVA or Grenz ray therapy within 4 weeks prior to randomisation
UVB therapy within 2 weeks prior to randomisation
Systemic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation
Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation
Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation
Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
No Results Posted