Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis

Psoriasis of Scalp Clinical Trial

Official title:

Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle, and the Gel Vehicle Alone in Scalp Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216827
• Other study ID #: MBL 0405 INT
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: March 25, 2015
• Start date: November 2004
• Est. completion date: September 2005

Study information

• Verified date: March 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaDenmark: Danish Medicines AgencySpain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Norway: Norwegian Medicines AgencySweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPortugal: National Pharmacy and Medicines InstituteUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.

The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1485
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 mild 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis of Scalp

Intervention

Drug:
• Calcipotriol plus betamethasone dipropionate (LEO80185 gel)

Locations

Country	Name	City	State
Canada	FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain	Quebec
Denmark	Roskilde Hospital, Division of Dermatology	Roskilde
France	Hôpital de l'Archet, Service de Dermatologie	Nice
Norway	Hudlegekontoret	Sandvika
Portugal	Hospitais da Universidade de Coimbra, Servico de dermatologia	Coimbra
Spain	Hospital Virgen de la Macarena, Servicio de Dermatología	Sevilla
Sweden	Akademiska Sjukhuset, Hudkliniken	Uppsala
United Kingdom	Western Infirmary, Dermatology Department	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Canada,  Denmark,  France,  Norway,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall disease severity according to investigator's assessment at week 8
Secondary	Total sign score at week 8
Secondary	Score for scaliness, redness and thickness at week 8
Secondary	Extent of scalp psoriasis at week 8
Secondary	Overall disease severity according to investigator's assessment at week 2 and 4
Secondary	Overall disease severity according to patients at week 8
Secondary	Adverse events
Secondary	Laboratory data

External Links

•   Clinical Trials at LEO Pharma