Status:
COMPLETED
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis
Lead Sponsor:
LEO Pharma
Conditions:
Psoriasis of Scalp
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate whether once daily topical 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 tha...
Eligibility Criteria
Inclusion
- Scalp psoriasis amenable to topical treatment with a maximum of 100 g of medication per week
- Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
- Extent of scalp psoriasis involving more than 10% of the total scalp area
- Investigator's assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, erythema, thickness and scaliness, and at least 1 in each of the other two clinical signs
- Disease severity on the scalp graded as Mild, Moderate, Severe or Very severe according to the investigator's global assessment of disease severity
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 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 :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
1350 Patients enrolled
Trial Details
Trial ID
NCT00216840
Start Date
December 1 2004
End Date
September 1 2005
Last Update
February 24 2025
Active Locations (7)
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1
Universitair Ziekenhuis Sint Rafaël, Dienst Dermatologie
Leuven, Belgium, BE-3000
2
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
3
Policlinic of Dermatology, Medical Reception Centre
Turku, Finland, SF-20100
4
Hôpital Trousseau, Service de Dermatologie CHU Tours
Tours, France, F-37044