Clinical trial NCT00216840: Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis
Official title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle and Calcipotriol in the Gel Vehicle in Scalp Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis of Scalp
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

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 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

Primary outcomes:
measure: - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.
Secondary outcomes:
measure: - Total sign score at week 8
measure: - Score for scaliness, redness and thickness at week 8
measure: - 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
measure: - Patients with "Treatment success" ("Almost clear" or "Cleared") according to patient's overall assessment of disease severity at week 8
measure: - Evaluation of Adverse Events
measure: - Evaluation of Laboratory Data
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Sint Rafaël, Dienst Dermatologie
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Turku
country: Finland
facility: Policlinic of Dermatology, Medical Reception Centre
city: Tours
country: France
facility: Hôpital Trousseau, Service de Dermatologie CHU Tours
city: Göttingen
country: Germany
facility: Georg-August-Universität Göttingen, Abteilung Dermatologie und Venerologie
city: Nijmegen
country: Netherlands
facility: Universitair Medisch, Centrum St. Radboud, Afdeling Dermatologie
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital, Department of Dermatology
Study officials:
affiliation: Universitair Medisch, Afdeling Dermatologie
name: Peter van de Kerkhof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van de Kerkhof PC, Hoffmann V, Anstey A, Barnes L, Bolduc C, Reich K, Saari S, Segaert S, Vaillant L. A new scalp formulation of calcipotriol plus betamethasone dipropionate compared with each of its active ingredients in the same vehicle for the treatment of scalp psoriasis: a randomized, double-blind, controlled trial. Br J Dermatol. 2009 Jan;160(1):170-6. doi: 10.1111/j.1365-2133.2008.08927.x. Epub 2008 Nov 25.