Official Title: “Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis”

The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment.

Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.

Study Type: Interventional

Study Design: Treatment, Randomized, Single 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 redness, thickness and scaliness at week 8
• Overall disease severity according to the investigator's assessment at week 2 and 4
• Overall disease severity according to patients at week 8
• Relapse and rebound during the study

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 moderate 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
• 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 non steroid 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

Knud Kragballe, MD Principal Investigator Department of Dermatology, Marselisborg Centres  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00243464

Study ID Number: MBL 0503 INT

ClinicalTrials.gov Identifier: NCT00243464

Health Authority: Belgium: Directorate general for the protection of Public health: Medicines