- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00216827
Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Quebec, Canada, G1V 4X7
- FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain
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Roskilde, Denmark, 4000
- Roskilde Hospital, Division of Dermatology
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Nice, France, 06202
- Hôpital de L'Archet, Service de Dermatologie
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Sandvika, Norway, 1338
- Hudlegekontoret
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Coimbra, Portugal, 3000-075
- Hospitais da Universidade de Coimbra, Servico de dermatologia
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Sevilla, Spain, 41009
- Hospital Virgen de la Macarena, Servicio de Dermatología
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Uppsala, Sweden, 751 85
- Akademiska Sjukhuset, Hudkliniken
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Glasgow, United Kingdom, G11 6NT
- Western Infirmary, Dermatology Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Overall disease severity according to investigator's assessment at week 8
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Secondary Outcome Measures
Outcome Measure |
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Adverse events
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Laboratory data
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Total sign score at week 8
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Score for scaliness, redness and thickness at week 8
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Extent of scalp psoriasis at week 8
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Overall disease severity according to investigator's assessment at week 2 and 4
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Overall disease severity according to patients at week 8
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gregor Jemec, MD, Roskilde Hospital, Division of Dermatology
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Betamethasone
- Betamethasone Valerate
- Betamethasone-17,21-dipropionate
- Betamethasone benzoate
- Calcipotriene
- Betamethasone sodium phosphate
Other Study ID Numbers
- MBL 0405 INT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Calcipotriol plus betamethasone dipropionate (LEO80185 gel)
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LEO PharmaCompletedPsoriasis of ScalpCanada, Belgium, Finland, France, Germany, Netherlands, United Kingdom
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LEO PharmaCompletedPsoriasis of ScalpFrance, Canada, Belgium, Denmark, Sweden
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LEO PharmaCompletedPsoriasis VulgarisIreland, Germany, United Kingdom, Canada, Sweden
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LEO PharmaCompletedPsoriasis of ScalpCanada, Denmark, France, Germany, United Kingdom
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Jooheung LeeCompletedPsoriasis VulgarisKorea, Republic of
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LEO PharmaCompleted
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LEO PharmaCompleted
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LEO PharmaCompleted
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LEO PharmaCompletedPsoriasis VulgarisRussian Federation
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Garlapati KomaliUnknown