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Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel 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
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 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 Investigator's assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, erythema, thickness and scaliness, and at least 1 in each of the other two clinical signs Disease severity on the scalp graded as Mild, Moderate, Severe or Very severe according to the investigator's global assessment of disease severity 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 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 Rafaël, Dienst Dermatologie
  • Innovaderm Research Inc.
  • Policlinic of Dermatology, Medical Reception Centre
  • Hôpital Trousseau, Service de Dermatologie CHU Tours
  • Georg-August-Universität Göttingen, Abteilung Dermatologie und Venerologie
  • Universitair Medisch, Centrum St. Radboud, Afdeling Dermatologie
  • Royal Gwent Hospital, Department of Dermatology

Outcomes

Primary Outcome Measures

- Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.

Secondary Outcome Measures

- Total sign score at week 8
- Score for scaliness, redness and thickness at week 8
- Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 2 and 4
- Patients with "Treatment success" ("Almost clear" or "Cleared") according to patient's overall assessment of disease severity at week 8
- Evaluation of Adverse Events
- Evaluation of Laboratory Data

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
NCT00216840
Brief Title
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis
Official Title
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle and Calcipotriol in the Gel Vehicle in Scalp Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 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 the study is to evaluate whether once daily topical 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 and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis. The primary response criterion is the number of patients with absence of disease and 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
1350 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Calcipotriol plus betamethasone dipropionate (LEO80185 gel)
Primary Outcome Measure Information:
Title
- Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity 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
- Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 2 and 4
Title
- Patients with "Treatment success" ("Almost clear" or "Cleared") according to patient's overall assessment of disease severity at week 8
Title
- Evaluation of Adverse Events
Title
- Evaluation of Laboratory Data

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 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 Investigator's assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, erythema, thickness and scaliness, and at least 1 in each of the other two clinical signs Disease severity on the scalp graded as Mild, Moderate, Severe or Very severe according to the investigator's global assessment of disease severity 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 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
Peter van de Kerkhof, MD
Organizational Affiliation
Universitair Medisch, Afdeling Dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Sint Rafaël, Dienst Dermatologie
City
Leuven
ZIP/Postal Code
BE-3000
Country
Belgium
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Policlinic of Dermatology, Medical Reception Centre
City
Turku
ZIP/Postal Code
SF-20100
Country
Finland
Facility Name
Hôpital Trousseau, Service de Dermatologie CHU Tours
City
Tours
ZIP/Postal Code
F-37044
Country
France
Facility Name
Georg-August-Universität Göttingen, Abteilung Dermatologie und Venerologie
City
Göttingen
ZIP/Postal Code
D-37075
Country
Germany
Facility Name
Universitair Medisch, Centrum St. Radboud, Afdeling Dermatologie
City
Nijmegen
ZIP/Postal Code
NL-6525
Country
Netherlands
Facility Name
Royal Gwent Hospital, Department of Dermatology
City
Newport
ZIP/Postal Code
NP20 2UB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19067709
Citation
van de Kerkhof PC, Hoffmann V, Anstey A, Barnes L, Bolduc C, Reich K, Saari S, Segaert S, Vaillant L. A new scalp formulation of calcipotriol plus betamethasone dipropionate compared with each of its active ingredients in the same vehicle for the treatment of scalp psoriasis: a randomized, double-blind, controlled trial. Br J Dermatol. 2009 Jan;160(1):170-6. doi: 10.1111/j.1365-2133.2008.08927.x. Epub 2008 Nov 25.
Results Reference
derived

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Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis

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