Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis
This study has been completed.
Sponsor:
LEO Pharma
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00243464
First received: October 21, 2005
Last updated: August 7, 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 plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment.
Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.
| 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: Single Blind Primary Purpose: Treatment |
| Official Title: | Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With 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 redness, thickness and scaliness at week 8
- Overall disease severity according to the investigator's assessment at week 2 and 4
- Overall disease severity according to patients at week 8
- Relapse and rebound during the study
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | May 2006 |
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 moderate 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
- 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 non steroid 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: NCT00243464
Locations
| Belgium | |
| Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie | |
| Leuven, Belgium, 3000 | |
| Canada, Ontario | |
| Windsor Clinical Research Inc. | |
| Windsor, Ontario, Canada, N8W5L7 | |
| Denmark | |
| Department of Dermatology, Marselisborg Centres | |
| Aarhus, Denmark, 8000 | |
| France | |
| Hôpital de L'Archet, Service de Dermatologie | |
| Nice, France, 06202 | |
| Sweden | |
| Läkarhuset | |
| Göteborg, Sweden, 41135 | |
Sponsors and Collaborators
LEO Pharma
Investigators
| Principal Investigator: | Knud Kragballe, MD | Department of Dermatology, Marselisborg Centres |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00243464 History of Changes |
| Other Study ID Numbers: | MBL 0503 INT |
| Study First Received: | October 21, 2005 |
| Last Updated: | August 7, 2007 |
| Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines Canada: Health Canada Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Sweden: Medical Products Agency |
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 19, 2013