Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis
- Conditions
- Psoriasis of Scalp
- Registration Number
- NCT00216840
- Lead Sponsor
- LEO Pharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1350
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.
- Secondary Outcome Measures
Name Time Method - Score for scaliness, redness and thickness at week 8 - Evaluation of Adverse Events - Patients with "Treatment success" ("Almost clear" or "Cleared") according to patient's overall assessment of disease severity at week 8 - Total sign score at week 8 - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 2 and 4 - Evaluation of Laboratory Data
Trial Locations
- Locations (7)
Georg-August-Universität Göttingen, Abteilung Dermatologie und Venerologie
🇩🇪Göttingen, Germany
Royal Gwent Hospital, Department of Dermatology
🇬🇧Newport, United Kingdom
Policlinic of Dermatology, Medical Reception Centre
🇫🇮Turku, Finland
Universitair Medisch, Centrum St. Radboud, Afdeling Dermatologie
🇳🇱Nijmegen, Netherlands
Hôpital Trousseau, Service de Dermatologie CHU Tours
🇫🇷Tours, France
Universitair Ziekenhuis Sint Rafaël, Dienst Dermatologie
🇧🇪Leuven, Belgium
Innovaderm Research Inc.
🇨🇦Montreal, Quebec, Canada