Status:
COMPLETED
Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis
Lead Sponsor:
LEO Pharma
Conditions:
Psoriasis of Scalp
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00243464
Start Date
September 1 2005
End Date
May 1 2006
Last Update
February 24 2025
Active Locations (5)
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1
Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie
Leuven, Belgium, 3000
2
Windsor Clinical Research Inc.
Windsor, Ontario, Canada, N8W5L7
3
Department of Dermatology, Marselisborg Centres
Aarhus, Denmark, 8000
4
Hôpital de L'Archet, Service de Dermatologie
Nice, France, 06202