Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis
- Conditions
- Psoriasis of Scalp
- Registration Number
- NCT00216827
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1485
- 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
- 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
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 Overall disease severity according to investigator's assessment at week 2 and 4 Overall disease severity according to patients at week 8 Adverse events Total sign score at week 8 Extent of scalp psoriasis at week 8 Laboratory data Score for scaliness, redness and thickness at week 8
Trial Locations
- Locations (8)
Hospital Virgen de la Macarena, Servicio de Dermatología
🇪🇸Sevilla, Spain
Western Infirmary, Dermatology Department
🇬🇧Glasgow, United Kingdom
Akademiska Sjukhuset, Hudkliniken
🇸🇪Uppsala, Sweden
Roskilde Hospital, Division of Dermatology
🇩🇰Roskilde, Denmark
Hudlegekontoret
🇳🇴Sandvika, Norway
Hospitais da Universidade de Coimbra, Servico de dermatologia
🇵🇹Coimbra, Portugal
FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain
🇨🇦Quebec, Canada
Hôpital de l'Archet, Service de Dermatologie
🇫🇷Nice, France