Clinical trial NCT00216827: Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis
Official title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle, and the Gel Vehicle Alone 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: 1485
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 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.


Eligibility criteria: 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 mild 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
* 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

Primary outcomes:
measure: Overall disease severity according to investigator's assessment at week 8
Secondary outcomes:
measure: Total sign score at week 8
measure: Score for scaliness, redness and thickness at week 8
measure: Extent of scalp psoriasis at week 8
measure: Overall disease severity according to investigator's assessment at week 2 and 4
measure: Overall disease severity according to patients at week 8
measure: Adverse events
measure: Laboratory data
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain
city: Roskilde
country: Denmark
facility: Roskilde Hospital, Division of Dermatology
city: Nice
country: France
facility: Hôpital de l'Archet, Service de Dermatologie
city: Sandvika
country: Norway
facility: Hudlegekontoret
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra, Servico de dermatologia
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena, Servicio de Dermatología
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset, Hudkliniken
city: Glasgow
country: United Kingdom
facility: Western Infirmary, Dermatology Department
Study officials:
affiliation: Roskilde Hospital, Division of Dermatology
name: Gregor Jemec, MD
role: PRINCIPAL_INVESTIGATOR
References: