Back to resultsEfficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in 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 moderate 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 Systemic 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 non steroid 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
- Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie
- Windsor Clinical Research Inc.
- Department of Dermatology, Marselisborg Centres
- Hôpital de L'Archet, Service de Dermatologie
- Läkarhuset
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 redness, thickness and scaliness at week 8
Overall disease severity according to the investigator's assessment at week 2 and 4
Overall disease severity according to patients at week 8
Relapse and rebound during the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00243464
Brief Title
Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis
Official Title
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (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 plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment.
Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.
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
Single
Allocation
Randomized
Enrollment
300 (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 redness, thickness and scaliness at week 8
Title
Overall disease severity according to the investigator's assessment at week 2 and 4
Title
Overall disease severity according to patients at week 8
Title
Relapse and rebound during the study
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 moderate 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
Systemic 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 non steroid 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
Knud Kragballe, MD
Organizational Affiliation
Department of Dermatology, Marselisborg Centres
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Windsor Clinical Research Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W5L7
Country
Canada
Facility Name
Department of Dermatology, Marselisborg Centres
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Hôpital de L'Archet, Service de Dermatologie
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Läkarhuset
City
Göteborg
ZIP/Postal Code
41135
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis
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