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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis of Scalp
• Intervention / Treatment: Drug: Calcipotriol plus betamethasone dipropionate gel (LEO 80185)

• Study Type: Interventional
• Enrollment: 800
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: T A Luger, Dr. med., Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten

Publications and helpful links

Helpful Links

• Clinical Trials at LEO Pharma

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion: December 7, 2022
• Study Completion: July 1, 2006

Study Registration Dates

• First Submitted: September 15, 2005
• First Submitted That Met QC Criteria: September 15, 2005
• First Posted (Estimated): September 22, 2005

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate; Calcipotriene
• Other Study ID Numbers: MBL 0407 INT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No