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

• ClinicalTrials.gov Identifier: NCT00216879
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Last Update Posted: March 26, 2015
• Sponsor: LEO Pharma
• Information provided by: LEO Pharma

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Psoriasis of Scalp	Drug: Calcipotriol plus betamethasone dipropionate gel (LEO 80185)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Long-term Treatment of Scalp Psoriasis With Calcipotriol Plus Betamethasone Dipropionate Gel
• Study Start Date: February 2005
• Study Completion Date: July 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• ClinicalTrials.gov Identifier: NCT00216879 History of Changes
• Other Study ID Numbers: MBL 0407 INT
• First Posted: September 22, 2005
• Last Update Posted: March 26, 2015
• Last Verified: March 2015

Additional relevant MeSH terms:

Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Calcitriol; Calcipotriene; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Agonists; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Vasoconstrictor Agents; Vitamins; Micronutrients; Nutrients; Growth Substances; Bone Density Conservation Agents