Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis

Psoriasis of Scalp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216840
• Other study ID #: MBL 0406 INT
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: March 25, 2015
• Start date: December 2004
• Est. completion date: September 2005

Study information

• Verified date: March 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Ireland: Irish Medicines BoardNetherlands: Dutch Health Care InspectorateUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis.

The primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1350
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

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
Belgium	Universitair Ziekenhuis Sint Rafaël, Dienst Dermatologie	Leuven
Canada	Innovaderm Research Inc.	Montreal	Quebec
Finland	Policlinic of Dermatology, Medical Reception Centre	Turku
France	Hôpital Trousseau, Service de Dermatologie CHU Tours	Tours
Germany	Georg-August-Universität Göttingen, Abteilung Dermatologie und Venerologie	Göttingen
Netherlands	Universitair Medisch, Centrum St. Radboud, Afdeling Dermatologie	Nijmegen
United Kingdom	Royal Gwent Hospital, Department of Dermatology	Newport

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Belgium,  Canada,  Finland,  France,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.
Secondary	- Total sign score at week 8
Secondary	- Score for scaliness, redness and thickness at week 8
Secondary	- Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 2 and 4
Secondary	- Patients with "Treatment success" ("Almost clear" or "Cleared") according to patient's overall assessment of disease severity at week 8
Secondary	- Evaluation of Adverse Events
Secondary	- Evaluation of Laboratory Data

External Links

•   Clinical Trials at LEO Pharma