Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris
Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis Vulgaris
Intervention: Calcipotriol plus betamethasone dipropionate (LEO 80185) gel (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: LEO Pharma Official(s) and/or principal investigator(s): Colin Fleming, MD, Principal Investigator, Affiliation: Ninewells Hospital and Medical School, Ninewells, Dundee, UK
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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 outcome: The absolute and percentage change in PASI from baseline to week 1, 2, 4, 6, and 8.Patients with "controlled disease" according to the investigators' global assessment of disease severity at week 1, 2, and 6. Patients with "clear" or "very mild" disease by the patient's global assessment of disease severity at week 1, 2, 4, 6, and 8.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Universitätsklinikum Leipzig, Leipzig 04103, Germany
Waterford Regional Hospital, Waterford, Ireland
Läkarhuset Vällingby, Vällingby 16268, Sweden
The Guenther Dermatology Research Centre, London, Ontario N6A3H7, Canada
Ninewells Hospital and Medical School, Dundee, Scotland DD1 9SY, United Kingdom
Additional Information
Clinical Trials at LEO Pharma
Starting date: December 2005
Last updated: March 25, 2015
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