Fingernail Psoriasis Clinical Trial
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
| Verified date | February 2009 |
| Source | MediQuest Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: Research Ethics Committee |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 83 |
| Est. completion date | January 2009 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Aberdeen Royal Infirmary Dermatology Outpatients Clinic | Aberdeen | |
| United Kingdom | Royal National Hospital for Rheumatic Diseases | Bath | |
| United Kingdom | University Hospital of Wales, Welsh Institute of Dermatology | Cardiff | |
| United Kingdom | Leeds General Infirmary Department of Dermatology | Leeds | |
| United Kingdom | George Eliot Hospital, Department of Dermatology | Nuneaton | |
| United Kingdom | University of Manchester, The Dermatology Centre | Salford | Manchester |
| United Kingdom | Great Western Hospital Rheumatology Department | Swindon | Wiltshire |
| Lead Sponsor | Collaborator |
|---|---|
| MediQuest Therapeutics |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators. | Monthly | No | |
| Secondary | Improvement in appearance of the control fingernail, improvement of the target fingernail using mNAPSI (a modification of the Nail Psoriasis Severity Index), and comparison of improvement of mNAPSI of the target and control fingernails. | Monthly | No | |
| Secondary | Information on the relative changes in nail psoriasis severity of the other affected fingernails will be collected. | Monthly | No | |
| Secondary | Comparison of nail growth of the target and control fingernails as determined from nail notch movement measured on nail photographs will be performed. | Monthly | No | |
| Secondary | Assess safety, i.e., the frequency and severity of adverse events associated with MQX-5902, MQX-5904 and MQX-5906 in the treatment of patients with fingernail psoriasis. | Monthly | Yes |