Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis

Psoriasis of Scalp Clinical Trial

Official title:

Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243464
• Other study ID #: MBL 0503 INT
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2005
• Last updated: March 25, 2015
• Start date: September 2005
• Est. completion date: May 2006

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 CanadaDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Sweden: Medical Products Agency
• 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 plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment.

Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2006
• 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 moderate 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

• 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 non steroid 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: Single 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 Raphaël, Dienst Dermatologie	Leuven
Canada	Windsor Clinical Research Inc.	Windsor	Ontario
Denmark	Department of Dermatology, Marselisborg Centres	Aarhus
France	Hôpital de L'Archet, Service de Dermatologie	Nice
Sweden	Läkarhuset	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Belgium,  Canada,  Denmark,  France,  Sweden, 

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 redness, thickness and scaliness at week 8
Secondary	Overall disease severity according to the investigator's assessment at week 2 and 4
Secondary	Overall disease severity according to patients at week 8
Secondary	Relapse and rebound during the study

External Links

•   Clinical Trials at LEO Pharma