Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis
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ClinicalTrials.gov Identifier: NCT00666354 |
Recruitment Status : Unknown
Verified February 2009 by MediQuest Therapeutics.
Recruitment status was: Active, not recruiting
First Posted : April 24, 2008
Last Update Posted : February 10, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fingernail Psoriasis | Drug: Methotrexate | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 83 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | October 2007 |
Estimated Primary Completion Date : | September 2008 |
Estimated Study Completion Date : | January 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1 |
Drug: Methotrexate
0.01 gram of topical amphimatrix containing 0.05% methotrexate per affected nail and adjacent skin folds applied daily for three months.
Other Name: MQX-5906 |
Active Comparator: 2 |
Drug: Methotrexate
0.01 gram of topical amphimatrix containing 0.25% methotrexate per affected nail and adjacent skin folds applied daily for three months.
Other Name: MQX-5902 |
Active Comparator: 3 |
Drug: Methotrexate
0.01 gram of topical amphimatrix containing 1.0% methotrexate per affected nail and adjacent skin folds applied daily for three months.
Other Name: MQX-5904 |
- Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators. [ Time Frame: Monthly ]
- 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. [ Time Frame: Monthly ]
- Information on the relative changes in nail psoriasis severity of the other affected fingernails will be collected. [ Time Frame: Monthly ]
- Comparison of nail growth of the target and control fingernails as determined from nail notch movement measured on nail photographs will be performed. [ Time Frame: Monthly ]
- 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. [ Time Frame: Monthly ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666354
United Kingdom | |
University of Manchester, The Dermatology Centre | |
Salford, Manchester, United Kingdom, M6 8HD | |
Great Western Hospital Rheumatology Department | |
Swindon, Wiltshire, United Kingdom, SN3 6BB | |
Aberdeen Royal Infirmary Dermatology Outpatients Clinic | |
Aberdeen, United Kingdom, AB25 2ZR | |
Royal National Hospital for Rheumatic Diseases | |
Bath, United Kingdom, BA1 1RL | |
University Hospital of Wales, Welsh Institute of Dermatology | |
Cardiff, United Kingdom, CF14 4XN | |
Leeds General Infirmary Department of Dermatology | |
Leeds, United Kingdom, LS1 3EX | |
George Eliot Hospital, Department of Dermatology | |
Nuneaton, United Kingdom, CV10 7DJ |
Principal Investigator: | Prof. Neil McHugh | Royal National Hospital for Rheumatic Diseases |
Responsible Party: | Fred Dechow/President and CEO, MediQuest Therapeutics |
ClinicalTrials.gov Identifier: | NCT00666354 |
Other Study ID Numbers: |
06-003 ISRCTN62739763 |
First Posted: | April 24, 2008 Key Record Dates |
Last Update Posted: | February 10, 2009 |
Last Verified: | February 2009 |
Nail Psoriasis Psoriasis Fingernail Psoriasis Methotrexate |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |