Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
MediQuest Therapeutics |
---|---|
Information provided by: | MediQuest Therapeutics |
ClinicalTrials.gov Identifier: | NCT00666354 |
The purpose of this clinical study is to compare the efficacy and safety of three concentrations of topical methotrexate for the treatment of fingernail psoriasis.
Condition | Intervention | Phase |
---|---|---|
Fingernail Psoriasis |
Drug: Methotrexate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase IIB Dose Response and Safety Study of Topical Formulations of Methotrexate (MQX-5902, MQX-5904 and MQX-5906) in the Treatment of Fingernail Psoriasis |
Estimated Enrollment: | 83 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Methotrexate
0.01 gram of topical amphimatrix containing 0.05% methotrexate per affected nail and adjacent skin folds applied daily for three months.
|
2: Active Comparator |
Drug: Methotrexate
0.01 gram of topical amphimatrix containing 0.25% methotrexate per affected nail and adjacent skin folds applied daily for three months.
|
3: Active Comparator |
Drug: Methotrexate
0.01 gram of topical amphimatrix containing 1.0% methotrexate per affected nail and adjacent skin folds applied daily for three months.
|
The purpose of this clinical study is to compare, in a controlled fashion, the response to three concentrations of methotrexate in novel topical formulations in the treatment of subjects with psoriasis of the fingernails. Such a determination will be used as the basis for evidence of efficacy and safety of these formulations as a therapeutic treatment for fingernail psoriasis.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Royal National Hospital for Rheumatic Diseases | |
Bath, United Kingdom, BA1 1RL | |
University Hospital of Wales, Welsh Institute of Dermatology | |
Cardiff, United Kingdom, CF14 4XN | |
Leeds General Infirmary Department of Dermatology | |
Leeds, United Kingdom, LS1 3EX | |
Aberdeen Royal Infirmary Dermatology Outpatients Clinic | |
Aberdeen, United Kingdom, AB25 2ZR | |
George Eliot Hospital, Department of Dermatology | |
Nuneaton, United Kingdom, CV10 7DJ | |
United Kingdom, Manchester | |
University of Manchester, The Dermatology Centre | |
Salford, Manchester, United Kingdom, M6 8HD | |
United Kingdom, Wiltshire | |
Great Western Hospital Rheumatology Department | |
Swindon, Wiltshire, United Kingdom, SN3 6BB |
Principal Investigator: | Prof. Neil McHugh | Royal National Hospital for Rheumatic Diseases |
Responsible Party: | MediQuest Therapeutics ( Fred Dechow/President and CEO ) |
Study ID Numbers: | 06-003, ISRCTN62739763 |
Study First Received: | April 22, 2008 |
Last Updated: | February 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00666354 History of Changes |
Health Authority: | United Kingdom: Research Ethics Committee |
Nail Psoriasis Psoriasis Fingernail Psoriasis Methotrexate |
Folic Acid Antimetabolites Immunologic Factors Skin Diseases Psoriasis |
Methotrexate Antirheumatic Agents Folic Acid Antagonists Immunosuppressive Agents Skin Diseases, Papulosquamous |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |
Immunosuppressive Agents Pharmacologic Actions Psoriasis Therapeutic Uses Abortifacient Agents Methotrexate Antirheumatic Agents Dermatologic Agents Skin Diseases, Papulosquamous Nucleic Acid Synthesis Inhibitors |