Status:
COMPLETED
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis
Lead Sponsor:
LEO Pharma
Conditions:
Psoriasis of Scalp
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol al...
Eligibility Criteria
Inclusion
- Scalp psoriasis amenable to topical treatment with a maximum of 100 g of study 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
- Disease severity on the scalp graded as Moderate, Severe or Very Severe according to the Investigator's Global Assessment of disease severity
Exclusion
- PUVA or Grenz ray therapy anywhere on the patient within 28 days prior to randomisation
- UVB therapy anywhere on the patient within 14 days prior to randomisation
- Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on, scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisaiton
- Systemic treatments with a potential effect on scalp psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 28 days prior to randomisation
- Any topical treatment for scalp psoriasis or any other skin disease on the scalp (excluding medicated shampoos, emollients and hair conditioners) within 14 days prior to randomisaiton
- Topical treatment for other skin disorders with very potent WHO group IV corticosteroids within 14 days prior to randomisation
- Planned initiation of, or changes in dose of concomitant medication that could affect scalp psoriasis (e.g., beta blockers, antimalarial drugs, lithium) during the study
- Current diagnosis of guttate, pustular, exfoliative or erythrodermic psoriasis
- Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin
- Known or suspected severe renal insufficiency or severe hepatic disorders
- Patiens with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
- Trial subjects should be using an adequate method of contraception
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00216879
Start Date
February 1 2005
End Date
July 1 2006
Last Update
February 24 2025
Active Locations (5)
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1
Clinique de Dermatologie
Moncton, Canada, E1C 8X3
2
Hørsholm Hospital, Dermatological Department
Hørsholm, Denmark, 2970
3
Hôpital Nord, Service de Dermatologie
Saint-Etienne, France, 42055
4
Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
Münster, Germany, 48179