Clinical trial NCT00666354: Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fingernail Psoriasis
Keywords: Nail Psoriasis
Psoriasis
Fingernail Psoriasis
Methotrexate
Lead sponsor: MediQuest Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators.
timeFrame: Monthly
Secondary outcomes:
measure: 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.
timeFrame: Monthly
measure: Information on the relative changes in nail psoriasis severity of the other affected fingernails will be collected.
timeFrame: Monthly
measure: Comparison of nail growth of the target and control fingernails as determined from nail notch movement measured on nail photographs will be performed.
timeFrame: Monthly
measure: 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.
timeFrame: Monthly
Other outcomes:
Locations:
city: Salford
country: United Kingdom
facility: University of Manchester, The Dermatology Centre
state: Manchester
city: Swindon
country: United Kingdom
facility: Great Western Hospital Rheumatology Department
state: Wiltshire
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary Dermatology Outpatients Clinic
city: Bath
country: United Kingdom
facility: Royal National Hospital for Rheumatic Diseases
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales, Welsh Institute of Dermatology
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary Department of Dermatology
city: Nuneaton
country: United Kingdom
facility: George Eliot Hospital, Department of Dermatology
Study officials:
affiliation: Royal National Hospital for Rheumatic Diseases
name: Prof. Neil McHugh
role: PRINCIPAL_INVESTIGATOR
References: