Status:
UNKNOWN
Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis
Lead Sponsor:
MediQuest Therapeutics
Conditions:
Fingernail Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 psoriasi...
Eligibility Criteria
Inclusion
- Diagnosed moderate fingernail psoriasis of at least two fingernails.
- Stable and unchanged psoriasis therapies for 2 months and must not have received methotrexate for 3 months prior to screening.
- Female patients who are not 5 years post menopausal or surgically sterile must use appropriate birth control for specified time periods and have negative pregnancy tests.
Exclusion
- Target or control fingernails that are thicker than 2mm, abnormal or infected (bacterial or fungal).
- Patients with immunosuppression, HIV, or neuropathies of the hand.
- Use of any methotrexate preparation, any topical anti-psoriatic medications or ultraviolet treatment within 2 months of study visit 1.
- Use of more that one 2-week course of oral corticosteroid therapy or one injection during 3 months prior to the screening visit.
- Use of manicures or cosmetic nail products during and within 7 days of the start of treatment.
- Use of any drug known to have potential for toxicity to a major organ during and within 90 days prior to the start of treatment.
- Patients who are nursing, pregnant or plan to become pregnant or father a child within the study time frame including within three months of the last dose of study medication.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00666354
Start Date
October 1 2007
End Date
January 1 2009
Last Update
February 10 2009
Active Locations (7)
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1
University of Manchester, The Dermatology Centre
Salford, Manchester, United Kingdom, M6 8HD
2
Great Western Hospital Rheumatology Department
Swindon, Wiltshire, United Kingdom, SN3 6BB
3
Aberdeen Royal Infirmary Dermatology Outpatients Clinic
Aberdeen, United Kingdom, AB25 2ZR
4
Royal National Hospital for Rheumatic Diseases
Bath, United Kingdom, BA1 1RL