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Trial record 49 of 277 for:    Betamethasone

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis

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ClinicalTrials.gov Identifier: NCT00216879
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 trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol alone in the same gel.

The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.


Condition or disease Intervention/treatment Phase
Psoriasis of Scalp Drug: Calcipotriol plus betamethasone dipropionate gel (LEO 80185) Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Long-term Treatment of Scalp Psoriasis With Calcipotriol Plus Betamethasone Dipropionate Gel
Study Start Date : February 2005
Study Completion Date : July 2006





Primary Outcome Measures :
  1. The proportions of patients who experience adverse drug reactions and the proportion of patients who experience adverse events of concern associated with long-term topical corticosteroid use on the scalp during the study

Secondary Outcome Measures :
  1. Percentage of post-baseline satisfactorily controlled assessments according to the Investigators' Global Assessment of disease severity during the study


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 study 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
  • Disease severity on the scalp graded as Moderate, Severe or Very Severe according to the Investigator's Global Assessment of disease severity

Exclusion Criteria:

  • PUVA or Grenz ray therapy anywhere on the patient within 28 days prior to randomisation
  • UVB therapy anywhere on the patient within 14 days prior to randomisation
  • Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on, scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisaiton
  • Systemic treatments with a potential effect on scalp psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 28 days prior to randomisation
  • Any topical treatment for scalp psoriasis or any other skin disease on the scalp (excluding medicated shampoos, emollients and hair conditioners) within 14 days prior to randomisaiton
  • Topical treatment for other skin disorders with very potent WHO group IV corticosteroids within 14 days prior to randomisation
  • Planned initiation of, or changes in dose of concomitant medication that could affect scalp psoriasis (e.g., beta blockers, antimalarial drugs, lithium) during the study
  • Current diagnosis of guttate, pustular, exfoliative or erythrodermic psoriasis
  • Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin
  • Known or suspected severe renal insufficiency or severe hepatic disorders
  • Patiens with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
  • Trial subjects should be using an adequate method of contraception

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): NCT00216879


Locations
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Canada
Clinique de Dermatologie
Moncton, Canada, E1C 8X3
Denmark
Hørsholm Hospital, Dermatological Department
Hørsholm, Denmark, 2970
France
Hôpital Nord, Service de Dermatologie
Saint-Etienne, France, 42055
Germany
Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
Münster, Germany, 48179
United Kingdom
Monklands Hospital, Department of Dermatology
Airdrie, United Kingdom, ML6 6JS
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: T A Luger, Dr. med. Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten

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ClinicalTrials.gov Identifier: NCT00216879     History of Changes
Other Study ID Numbers: MBL 0407 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