Clinical trial NCT00263718: Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris
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 Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2005-12-09
Enrollment: 360
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 objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk and/or limbs. Patients will be treated once daily for up to 8 weeks.

The primary response criterion is the number of patients with controlled disease at week 8.


Eligibility criteria: Inclusion Criteria:

* Psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of topical medication per week
* An investigators' global assessment of disease severity of at least mild

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 psoriasis vulgaris within 6 months prior to randomisation
* Systemic treatment with all other therapies than biologicals, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
* Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation
* Topical treatment for other relevant skin disorders (except WHO group I-II corticosteroids, tar, retinoid and dithranol on face, scalp, or flexures) within 2 weeks prior to randomisation
* Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium) during the study
* Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

Primary outcomes:
measure: Patients with "controlled disease" (minimal or clear and at least two steps change from baseline) according to the investigators' global assessment of disease severity at week 4 and week 8.
Secondary outcomes:
measure: The absolute and percentage change in PASI from baseline to week 1, 2, 4, 6, and 8.
measure: Patients with "controlled disease" according to the investigators' global assessment of disease severity at week 1, 2, and 6.
measure: Patients with "clear" or "very mild" disease by the patient's global assessment of disease severity at week 1, 2, 4, 6, and 8.
Other outcomes:
Locations:
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
city: Vällingby
country: Sweden
facility: Läkarhuset Vällingby
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Scotland
Study officials:
affiliation: Ninewells Hospital and Medical School, Ninewells, Dundee, UK
name: Colin Fleming, MD
role: PRINCIPAL_INVESTIGATOR
References: