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

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ClinicalTrials.gov Identifier: NCT00216827
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 26, 2015
Sponsor:
Information provided by:
LEO Pharma

Study Description
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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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 1485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : November 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Overall disease severity according to investigator's assessment at week 8

Secondary Outcome Measures :
  1. Total sign score at week 8
  2. Score for scaliness, redness and thickness at week 8
  3. Extent of scalp psoriasis at week 8
  4. Overall disease severity according to investigator's assessment at week 2 and 4
  5. Overall disease severity according to patients at week 8
  6. Adverse events
  7. Laboratory data

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216827


Locations
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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
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Principal Investigator: Gregor Jemec, MD Roskilde Hospital, Division of Dermatology
More Information
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ClinicalTrials.gov Identifier: NCT00216827     History of Changes
Other Study ID Numbers: MBL 0405 INT
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcipotriene
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents