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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Calcipotriene Bentelan Betamethasone Betamethasone dipropionate

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00243464 History of Changes
Other Study ID Numbers:	MBL 0503 INT
Study First Received:	October 21, 2005
Last Updated:	August 7, 2007
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

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012