Dose response and safety study of topical methotrexate for the treatment of fingernail psoriasis
ISRCTN | ISRCTN62739763 |
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DOI | https://doi.org/10.1186/ISRCTN62739763 |
ClinicalTrials.gov number | NCT00666354 |
Secondary identifying numbers | 06-003 |
- Submission date
- 11/04/2008
- Registration date
- 24/04/2008
- Last edited
- 26/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Neil McHugh
Scientific
Scientific
Royal National Hospital for Rheumatic Diseases
Upper Borough Walls
Bath
BA1 1RL
United Kingdom
Study information
Study design | Multi-centre, randomised, double-blind, efficacy and safety study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 |
Study objectives | 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(s) | South West Research Ethics Committee, 17/04/2007, ref: 07/MRE06/25 |
Health condition(s) or problem(s) studied | Psoriasis of the fingernail |
Intervention | 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. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase II/III |
Drug / device / biological / vaccine name(s) | Topical formulations of methotrexate (MQX-5902, MQX-5904 and MQX-5906) |
Primary outcome measure | 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 measures | 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. |
Overall study start date | 01/10/2007 |
Completion date | 01/01/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 75 Years |
Sex | Both |
Target number of participants | 83 |
Key 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 |
Key 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 |
Date of first enrolment | 01/10/2007 |
Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal National Hospital for Rheumatic Diseases
Bath
BA1 1RL
United Kingdom
BA1 1RL
United Kingdom
Sponsor information
MediQuest Therapeutics, Inc. (USA)
Industry
Industry
22322 20th Ave. S.E.
Suite 100
Bothell
98021
United States of America
Phone | +1 425 398 9580 |
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info@mqti.com | |
Website | http://www.mqti.com |
Funders
Funder type
Industry
MediQuest Therapeutics, Inc. (USA)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
26/02/2019: No publications found, verifying study status with principal investigator
27/04/2016: No publications found, verifying study status with principal investigator