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Trial record 46 of 272 for:    Betamethasone

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

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ClinicalTrials.gov Identifier: NCT00216840
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 26, 2015
Sponsor:
Information provided by:
LEO Pharma

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.


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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1350 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 and Calcipotriol in the Gel Vehicle in Scalp Psoriasis
Study Start Date : December 2004
Study Completion Date : September 2005





Primary Outcome Measures :
  1. - 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 :
  1. - Total sign score at week 8
  2. - Score for scaliness, redness and thickness at week 8
  3. - 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
  4. - Patients with "Treatment success" ("Almost clear" or "Cleared") according to patient's overall assessment of disease severity at week 8
  5. - Evaluation of Adverse Events
  6. - Evaluation of Laboratory Data


Information from the National Library of Medicine

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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

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

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): NCT00216840


Locations
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Belgium
Universitair Ziekenhuis Sint Rafaël, Dienst Dermatologie
Leuven, Belgium, BE-3000
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Finland
Policlinic of Dermatology, Medical Reception Centre
Turku, Finland, SF-20100
France
Hôpital Trousseau, Service de Dermatologie CHU Tours
Tours, France, F-37044
Germany
Georg-August-Universität Göttingen, Abteilung Dermatologie und Venerologie
Göttingen, Germany, D-37075
Netherlands
Universitair Medisch, Centrum St. Radboud, Afdeling Dermatologie
Nijmegen, Netherlands, NL-6525
United Kingdom
Royal Gwent Hospital, Department of Dermatology
Newport, United Kingdom, NP20 2UB
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Peter van de Kerkhof, MD Universitair Medisch, Afdeling Dermatologie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00216840     History of Changes
Other Study ID Numbers: MBL 0406 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