Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis

• Status: Unknown status
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MediQuest Therapeutics
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.