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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN62739763 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
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| 3 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | 0.01 gram of topical amphimatrix containing 0.05% methotrexate per affected nail and adjacent skin folds applied daily for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators. | Monthly |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Information on the relative changes in nail psoriasis severity of the other affected fingernails will be collected. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Neil McHugh | Royal National Hospital for Rheumatic Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manchester, The Dermatology Centre | Salford | Manchester | M6 8HD | United Kingdom | ||
| Great Western Hospital Rheumatology Department |
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| Methotrexate | Drug | 0.01 gram of topical amphimatrix containing 0.25% methotrexate per affected nail and adjacent skin folds applied daily for three months. |
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| Methotrexate | Drug | 0.01 gram of topical amphimatrix containing 1.0% methotrexate per affected nail and adjacent skin folds applied daily for three months. |
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| Monthly |
| Comparison of nail growth of the target and control fingernails as determined from nail notch movement measured on nail photographs will be performed. | 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. | Monthly |
| Swindon |
| Wiltshire |
| SN3 6BB |
| United Kingdom |
| Aberdeen Royal Infirmary Dermatology Outpatients Clinic | Aberdeen | AB25 2ZR | United Kingdom |
| Royal National Hospital for Rheumatic Diseases | Bath | BA1 1RL | United Kingdom |
| University Hospital of Wales, Welsh Institute of Dermatology | Cardiff | CF14 4XN | United Kingdom |
| Leeds General Infirmary Department of Dermatology | Leeds | LS1 3EX | United Kingdom |
| George Eliot Hospital, Department of Dermatology | Nuneaton | CV10 7DJ | United Kingdom |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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