Status:
COMPLETED
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris
Lead Sponsor:
LEO Pharma
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 veh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00263718
Start Date
December 1 2005
End Date
May 1 2006
Last Update
February 24 2025
Active Locations (5)
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1
The Guenther Dermatology Research Centre
London, Ontario, Canada, N6A3H7
2
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
3
Waterford Regional Hospital
Waterford, Ireland
4
Läkarhuset Vällingby
Vällingby, Sweden, 16268