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| [ Print-friendly version ] |
| Dose response and safety study of topical methotrexate for the treatment of fingernail psoriasis |
| ISRCTN | ISRCTN62739763 |
| ClinicalTrials.gov identifier | NCT00666354 |
| Public title | Dose response and safety study of topical methotrexate for the treatment of fingernail psoriasis |
| Scientific 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 |
| Acronym | N/A |
| Serial number at source | 06-003 |
| Study hypothesis | 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. |
| Ethics approval | Ethics approval received from the South West Research Ethics Committee on the 17th April 2007 (ref: 07/MRE06/25). |
| Study design | Multi-centre, randomised, double-blind, efficacy and safety study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Psoriasis of the fingernail |
| Participants - inclusion criteria |
1. Diagnosed moderate fingernail psoriasis of at least two fingernails
2. Stable and unchanged psoriasis therapies for two months and must not have received methotrexate for three months prior to screening 3. Female patients who are not five years post menopausal or surgically sterile must use appropriate birth control for specified time periods and have negative pregnancy tests 4. 18 - 75 years of age and either sex |
| Participants - exclusion criteria |
1. Target or control fingernails that are thicker than 2 mm, abnormal or infected (bacterial or fungal)
2. Patients with immunosuppression, human immunodeficiency virus (HIV), or neuropathies of the hand 3. Use of any methotrexate preparation, any topical anti-psoriatic medications or ultraviolet treatment within two months of study visit one 4. Use of more that one two-week course of oral corticosteroid therapy or one injection during three months prior to the screening visit 5. Use of manicures or cosmetic nail products during and within seven days of the start of treatment 6. 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 7. 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 |
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 01/01/2009 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 83 |
| Interventions |
1. Active comparator one:
Drug: methotrexate (other names: MQX-5906) Dosing: 0.01 g of topical amphimatrix containing 0.05% methotrexate per affected nail and adjacent skin folds applied daily for three months 2. Active comparator two: Drug: methotrexate (other names: MQX-5902) Dosing: 0.01 g of topical amphimatrix containing 0.25% methotrexate per affected nail and adjacent skin folds applied daily for three months 3. Active comparator three: Drug: methotrexate (other names: MQX-5904) Dosing: 0.01 g of topical amphimatrix containing 1.0% methotrexate per affected nail and adjacent skin folds applied daily for three months Total duration of follow-up is 1 month. |
| Primary outcome measure(s) |
1. Evaluate improvements in the appearance of the target fingernail, utilising photography for imaging and independent photograph evaluators, measured monthly for 4 months
2. 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, measured monthly for 5 months |
| Secondary outcome measure(s) |
Secondary endpoints will include:
1. The improvement in the appearance of the control fingernail as determined by independent evaluators 2. The improvement of the target fingernail as measured by the investigator using the mNAPSI (a modification of the Nail Psoriasis Severity Index) 3. A comparison of the improvement of the mNAPSI of the target and control fingernails 4. Information on the relative changes in nail psoriasis severity of the other affected fingernails 5. A comparison of nail growth of the target and control fingernails as determined from nail notch movement measured on nail photographs Secondary outcomes measured monthly for 4 months. |
| Sources of funding | MediQuest Therapeutics, Inc. (USA) |
| Trial website | |
| Publications | |
| Contact name | Prof Neil McHugh |
| Address |
Royal National Hospital for Rheumatic Diseases
Upper Borough Walls |
| City/town | Bath |
| Zip/Postcode | BA1 1RL |
| Country | United Kingdom |
| Sponsor | MediQuest Therapeutics, Inc. (USA) |
| Address |
22322 20th Ave. S.E.
Suite 100 |
| City/town | Bothell |
| Zip/Postcode | 98021 |
| Country | United States of America |
| Tel | +1 425 398 9580 |
| Fax | +1 425 398 9590 |
| info@mqti.com | |
| Sponsor website: | http://www.mqti.com |
| Date applied | 11/04/2008 |
| Last edited | 25/04/2008 |
| Date ISRCTN assigned | 24/04/2008 |
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