Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis
- Conditions
- Psoriasis of Scalp
- Registration Number
- NCT00243464
- Lead Sponsor
- LEO Pharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall disease severity according to investigator's assessment at week 8
- Secondary Outcome Measures
Name Time Method Total sign score at week 8 Overall disease severity according to the investigator's assessment at week 2 and 4 Relapse and rebound during the study Score for redness, thickness and scaliness at week 8 Overall disease severity according to patients at week 8
Trial Locations
- Locations (5)
Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie
🇧🇪Leuven, Belgium
Windsor Clinical Research Inc.
🇨🇦Windsor, Ontario, Canada
Department of Dermatology, Marselisborg Centres
🇩🇰Aarhus, Denmark
Hôpital de L'Archet, Service de Dermatologie
🇫🇷Nice, France
Läkarhuset
🇸🇪Göteborg, Sweden