Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis
This study has been completed.
Sponsor:
LEO Pharma
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00216827
First received: September 15, 2005
Last updated: August 2, 2007
Last verified: August 2007
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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:
MedlinePlus related topics:
Psoriasis
Drug Information available for:
Betamethasone sodium phosphate
Betamethasone
Betamethasone valerate
Betamethasone dipropionate
Calcipotriene
U.S. FDA Resources
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 May 21, 2013