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Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris

This study has been completed.
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00263718
First received: December 8, 2005
Last updated: February 20, 2008
Last verified: February 2008
History of Changes

December 8, 2005
February 20, 2008
December 2005
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00263718 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Psoriasis Vulgaris
Drug: Calcipotriol plus betamethasone dipropionate (LEO 80185) gel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
May 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Ireland,   Sweden,   United Kingdom
 
NCT00263718
MBL 0202 INT
Not Provided
Not Provided
LEO Pharma
Not Provided
Principal Investigator: Colin Fleming, MD Ninewells Hospital and Medical School, Ninewells, Dundee, UK
LEO Pharma
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP