Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Psoriasis of Scalp	Drug: Calcipotriol plus betamethasone dipropionate (LEO80185 gel)	Phase III

MedlinePlus related topics:

Psoriasis

ChemIDplus related topics:

Calcipotriene Betamethasone Bentelan Betamethasone dipropionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by LEO Pharma:

Primary Outcome Measures:

Overall disease severity according to investigator's assessment at week 8

Secondary Outcome Measures:

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

Estimated Enrollment:	300
Study Start Date:	September 2005
Estimated Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243464

Locations


Belgium
	Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie
	Leuven, Belgium, 3000

Canada, Ontario
	Windsor Clinical Research Inc.
	Windsor, Ontario, Canada, N8W5L7

Denmark
	Department of Dermatology, Marselisborg Centres
	Aarhus, Denmark, 8000

France
	Hôpital de L'Archet, Service de Dermatologie
	Nice, France, 06202

Sweden
	Läkarhuset
	Göteborg, Sweden, 41135

Sponsors and Collaborators

LEO Pharma

Investigators


Principal Investigator:	Knud Kragballe, MD	Department of Dermatology, Marselisborg Centres

More Information

Study ID Numbers:	MBL 0503 INT
First Received:	October 21, 2005
Last Updated:	August 7, 2007
ClinicalTrials.gov Identifier:	NCT00243464
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Sweden: Medical Products Agency

Study placed in the following topic categories:

Calcipotriene

Betamethasone-17,21-dipropionate

Sodium phosphate

Skin Diseases

Psoriasis

Betamethasone sodium phosphate

Betamethasone

Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Dermatologic Agents

Hormones

Glucocorticoids

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	LEO Pharma
Information provided by:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00243464