Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis

Psoriasis of Scalp Clinical Trial

Official title:

Long-term Treatment of Scalp Psoriasis With Calcipotriol Plus Betamethasone Dipropionate Gel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216879
• Other study ID #: MBL 0407 INT
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: March 25, 2015
• Start date: February 2005
• Est. completion date: July 2006

Study information

• Verified date: March 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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 alone in the same gel.

The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: July 2006
• 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 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 Criteria:

• 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

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 gel (LEO 80185)

Locations

Country	Name	City	State
Canada	Clinique de Dermatologie	Moncton
Denmark	Hørsholm Hospital, Dermatological Department	Hørsholm
France	Hôpital Nord, Service de Dermatologie	Saint-Etienne
Germany	Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten	Münster
United Kingdom	Monklands Hospital, Department of Dermatology	Airdrie

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Canada,  Denmark,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportions of patients who experience adverse drug reactions and the proportion of patients who experience adverse events of concern associated with long-term topical corticosteroid use on the scalp during the study
Secondary	Percentage of post-baseline satisfactorily controlled assessments according to the Investigators' Global Assessment of disease severity during the study

External Links

•   Clinical Trials at LEO Pharma