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

Sponsor:	LEO Pharma
Information provided by:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00216879

Purpose

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.

Condition	Intervention	Phase
Psoriasis of Scalp	Drug: Calcipotriol plus betamethasone dipropionate gel (LEO 80185)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Long-Term Treatment of Scalp Psoriasis With Calcipotriol Plus Betamethasone Dipropionate Gel

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:

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 Outcome Measures:

Percentage of post-baseline satisfactorily controlled assessments according to the Investigators' Global Assessment of disease severity during the study

Estimated Enrollment:	800
Study Start Date:	February 2005
Estimated Study Completion Date:	July 2006

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216879

Locations

Canada
Clinique de Dermatologie
Moncton, Canada, E1C 8X3
Denmark
Hørsholm Hospital, Dermatological Department
Hørsholm, Denmark, 2970
France
Hôpital Nord, Service de Dermatologie
Saint-Etienne, France, 42055
Germany
Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
Münster, Germany, 48179
United Kingdom
Monklands Hospital, Department of Dermatology
Airdrie, United Kingdom, ML6 6JS

Sponsors and Collaborators

LEO Pharma

Investigators

Principal Investigator:

T A Luger, Dr. med.

Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00216879 History of Changes
Other Study ID Numbers:	MBL 0407 INT
Study First Received:	September 15, 2005
Last Updated:	August 2, 2007
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory 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