Back to resultsEfficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis
Primary Purpose
Psoriasis of Scalp
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Calcipotriol plus betamethasone dipropionate (LEO80185 gel)
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis of Scalp
Eligibility 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 mild 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 Systematic 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 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
Sites / Locations
- FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain
- Roskilde Hospital, Division of Dermatology
- Hôpital de l'Archet, Service de Dermatologie
- Hudlegekontoret
- Hospitais da Universidade de Coimbra, Servico de dermatologia
- Hospital Virgen de la Macarena, Servicio de Dermatología
- Akademiska Sjukhuset, Hudkliniken
- Western Infirmary, Dermatology Department
Outcomes
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 scaliness, redness and thickness at week 8
Extent of scalp psoriasis at week 8
Overall disease severity according to investigator's assessment at week 2 and 4
Overall disease severity according to patients at week 8
Adverse events
Laboratory data
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00216827
Brief Title
Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis
Official Title
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle, and the Gel Vehicle Alone in Scalp Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
LEO Pharma
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.
The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.
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
1485 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Calcipotriol plus betamethasone dipropionate (LEO80185 gel)
Primary Outcome Measure Information:
Title
Overall disease severity according to investigator's assessment at week 8
Secondary Outcome Measure Information:
Title
Total sign score at week 8
Title
Score for scaliness, redness and thickness at week 8
Title
Extent of scalp psoriasis at week 8
Title
Overall disease severity according to investigator's assessment at week 2 and 4
Title
Overall disease severity according to patients at week 8
Title
Adverse events
Title
Laboratory data
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 mild 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
Systematic 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregor Jemec, MD
Organizational Affiliation
Roskilde Hospital, Division of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Roskilde Hospital, Division of Dermatology
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Hôpital de l'Archet, Service de Dermatologie
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hudlegekontoret
City
Sandvika
ZIP/Postal Code
1338
Country
Norway
Facility Name
Hospitais da Universidade de Coimbra, Servico de dermatologia
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Virgen de la Macarena, Servicio de Dermatología
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Akademiska Sjukhuset, Hudkliniken
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Western Infirmary, Dermatology Department
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis
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