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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fingernail Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

0.01 gram of topical amphimatrix containing 0.05% methotrexate per affected nail and adjacent skin folds applied daily for three months.

2

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

0.01 gram of topical amphimatrix containing 0.25% methotrexate per affected nail and adjacent skin folds applied daily for three months.

3

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

0.01 gram of topical amphimatrix containing 1.0% methotrexate per affected nail and adjacent skin folds applied daily for three months.

Interventions

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Methotrexate

0.01 gram of topical amphimatrix containing 0.05% methotrexate per affected nail and adjacent skin folds applied daily for three months.

Intervention Type DRUG

Methotrexate

0.01 gram of topical amphimatrix containing 0.25% methotrexate per affected nail and adjacent skin folds applied daily for three months.

Intervention Type DRUG

Methotrexate

0.01 gram of topical amphimatrix containing 1.0% methotrexate per affected nail and adjacent skin folds applied daily for three months.

Intervention Type DRUG

Other Intervention Names

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MQX-5906 MQX-5902 MQX-5904

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No