Status:
COMPLETED
Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of 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 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betam...
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 mild 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
- Systematic 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 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 :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
1485 Patients enrolled
Trial Details
Trial ID
NCT00216827
Start Date
November 1 2004
End Date
September 1 2005
Last Update
February 24 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Canada, G1V 4X7
2
Roskilde Hospital, Division of Dermatology
Roskilde, Denmark, 4000
3
Hôpital de l'Archet, Service de Dermatologie
Nice, France, 06202
4
Hudlegekontoret
Sandvika, Norway, 1338