Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis
Information source: LEO Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis of Scalp
Intervention: Calcipotriol plus betamethasone dipropionate (LEO80185 gel) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: LEO Pharma Official(s) and/or principal investigator(s):
Knud Kragballe, MD, Principal Investigator, Affiliation: Department of Dermatology, Marselisborg Centres
Summary
The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of
calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment
of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is
patients with clear or minimal disease after 8 weeks treatment.
Further the occurrence of relapse and rebound after end of treatment in patients with clear
or minimal disease will be investigated.
Clinical Details
Official title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Overall disease severity according to investigator's assessment at week 8
Secondary outcome: Total sign score at week 8Score for redness, thickness and scaliness at week 8 Overall disease severity according to the investigator's assessment at week 2 and 4 Overall disease severity according to patients at week 8 Relapse and rebound during the study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 moderate 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
- Systemic 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 non steroid 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
Locations and Contacts
Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie, Leuven 3000, Belgium
Department of Dermatology, Marselisborg Centres, Aarhus 8000, Denmark
Hôpital de L'Archet, Service de Dermatologie, Nice 06202, France
Läkarhuset, Göteborg 41135, Sweden
Windsor Clinical Research Inc., Windsor, Ontario N8W5L7, Canada
Additional Information
Starting date: September 2005
Ending date: May 2006
Last updated: August 7, 2007
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