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

Primary Purpose

Psoriasis of Scalp

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Calcipotriol plus betamethasone dipropionate gel (LEO 80185)
Sponsored by
LEO Pharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis of Scalp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique de Dermatologie
  • Hørsholm Hospital, Dermatological Department
  • Hôpital Nord, Service de Dermatologie
  • Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
  • Monklands Hospital, Department of Dermatology

Outcomes

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

Full Information

First Posted
September 15, 2005
Last Updated
March 25, 2015
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00216879
Brief Title
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis
Official Title
Long-term Treatment of Scalp Psoriasis With Calcipotriol Plus Betamethasone Dipropionate Gel
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
LEO Pharma

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis of Scalp

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
800 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Calcipotriol plus betamethasone dipropionate gel (LEO 80185)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Percentage of post-baseline satisfactorily controlled assessments according to the Investigators' Global Assessment of disease severity during the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T A Luger, Dr. med.
Organizational Affiliation
Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique de Dermatologie
City
Moncton
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Hørsholm Hospital, Dermatological Department
City
Hørsholm
ZIP/Postal Code
2970
Country
Denmark
Facility Name
Hôpital Nord, Service de Dermatologie
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
City
Münster
ZIP/Postal Code
48179
Country
Germany
Facility Name
Monklands Hospital, Department of Dermatology
City
Airdrie
ZIP/Postal Code
ML6 6JS
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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