Dose response and safety study of topical methotrexate for the treatment of fingernail psoriasis

ISRCTN ISRCTN62739763
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

Royal National Hospital for Rheumatic Diseases
Upper Borough Walls
Bath
BA1 1RL
United Kingdom

Study information

Study designMulti-centre, randomised, double-blind, efficacy and safety study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePhase 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 objectivesThe 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) studiedPsoriasis of the fingernail
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II/III
Drug / device / biological / vaccine name(s)Topical formulations of methotrexate (MQX-5902, MQX-5904 and MQX-5906)
Primary outcome measure1. 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 measuresSecondary 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 date01/10/2007
Completion date01/01/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participants83
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2007
Date of final enrolment01/01/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal National Hospital for Rheumatic Diseases
Bath
BA1 1RL
United Kingdom

Sponsor information

MediQuest Therapeutics, Inc. (USA)
Industry

22322 20th Ave. S.E.
Suite 100
Bothell
98021
United States of America

Phone +1 425 398 9580
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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