Official Title: “Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle, and the Gel Vehicle Alone in Scalp Psoriasis”

The purpose of this study is to evaluate whether once daily 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, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.

The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Calcipotriol plus betamethasone dipropionate (LEO80185 gel)

Primary Measures

• Overall disease severity according to investigator's assessment at week 8

Secondary Measures

• Total sign score at week 8
• Score for scaliness, redness and thickness at week 8
• Extent of scalp psoriasis at week 8
• Overall disease severity according to investigator's assessment at week 2 and 4
• Overall disease severity according to patients at week 8
• Adverse events
• Laboratory data

Main Inclusion Criteria:

• Scalp psoriasis amenable to topical treatment
• 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 mild or worse by the investigator
• Consenting out-patients of 18 years or above

Main Exclusion Criteria:

• PUVA or Grenz ray therapy within 4 weeks prior to randomisation
• UVB therapy within 2 weeks prior to randomisation
• Systematic 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: LEO Pharma

Overall Clinical Trial Officials and Contacts

Gregor Jemec, MD Principal Investigator Roskilde Hospital, Division of Dermatology  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00216827

Study ID Number: MBL 0405 INT

ClinicalTrials.gov Identifier: NCT00216827

Health Authority: Canada: Health Canada