Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris
This study has been completed.
Sponsor:
LEO Pharma
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00263718
First received: December 8, 2005
Last updated: February 20, 2008
Last verified: February 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk and/or limbs. Patients will be treated once daily for up to 8 weeks.
The primary response criterion is the number of patients with controlled disease at week 8.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis Vulgaris |
Drug: Calcipotriol plus betamethasone dipropionate (LEO 80185) gel |
Phase 2 |
| 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 Psoriasis Vulgaris |
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:
- Patients with "controlled disease" (minimal or clear and at least two steps change from baseline) according to the investigators' global assessment of disease severity at week 4 and week 8.
Secondary Outcome Measures:
- The absolute and percentage change in PASI from baseline to week 1, 2, 4, 6, and 8.
- Patients with "controlled disease" according to the investigators' global assessment of disease severity at week 1, 2, and 6.
- Patients with "clear" or "very mild" disease by the patient's global assessment of disease severity at week 1, 2, 4, 6, and 8.
| Estimated Enrollment: | 360 |
| Study Start Date: | December 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
Inclusion Criteria:
- Psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of topical medication per week
- An investigators' global assessment of disease severity of at least mild
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 psoriasis vulgaris within 6 months prior to randomisation
- Systemic treatment with all other therapies than biologicals, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
- Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation
- Topical treatment for other relevant skin disorders (except WHO group I-II corticosteroids, tar, retinoid and dithranol on face, scalp, or flexures) within 2 weeks prior to randomisation
- Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium) during the study
- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263718
Locations
| Canada, Ontario | |
| The Guenther Dermatology Research Centre | |
| London, Ontario, Canada, N6A3H7 | |
| Germany | |
| Universitätsklinikum Leipzig | |
| Leipzig, Germany, 04103 | |
| Ireland | |
| Waterford Regional Hospital | |
| Waterford, Ireland | |
| Sweden | |
| Läkarhuset Vällingby | |
| Vällingby, Sweden, 16268 | |
| United Kingdom | |
| Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
Sponsors and Collaborators
LEO Pharma
Investigators
| Principal Investigator: | Colin Fleming, MD | Ninewells Hospital and Medical School, Ninewells, Dundee, UK |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00263718 History of Changes |
| Other Study ID Numbers: | MBL 0202 INT |
| Study First Received: | December 8, 2005 |
| Last Updated: | February 20, 2008 |
| Health Authority: | Canada: Health Canada Ireland: Irish Medicines Board Sweden: Medical Products Agency Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory 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 23, 2013