Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis

This study has been completed.
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00216827
First received: September 15, 2005
Last updated: August 2, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Psoriasis of Scalp
Drug: Calcipotriol plus betamethasone dipropionate (LEO80185 gel)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

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

Estimated Enrollment: 1485
Study Start Date: November 2004
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216827

Locations
Canada
FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain
Quebec, Canada, G1V 4X7
Denmark
Roskilde Hospital, Division of Dermatology
Roskilde, Denmark, 4000
France
Hôpital de l'Archet, Service de Dermatologie
Nice, France, 06202
Norway
Hudlegekontoret
Sandvika, Norway, 1338
Portugal
Hospitais da Universidade de Coimbra, Servico de dermatologia
Coimbra, Portugal, 3000-075
Spain
Hospital Virgen de la Macarena, Servicio de Dermatología
Sevilla, Spain, 41009
Sweden
Akademiska Sjukhuset, Hudkliniken
Uppsala, Sweden, 751 85
United Kingdom
Western Infirmary, Dermatology Department
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Gregor Jemec, MD Roskilde Hospital, Division of Dermatology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00216827     History of Changes
Other Study ID Numbers: MBL 0405 INT
Study First Received: September 15, 2005
Last Updated: August 2, 2007
Health Authority: Canada: Health Canada
Denmark: Danish Medicines Agency
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Portugal: National Pharmacy and Medicines Institute
United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014