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 (NCT)	NCT00666354
Protocol serial number	06-003
Sponsor	MediQuest Therapeutics, Inc. (USA)
Funder	MediQuest Therapeutics, Inc. (USA)

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

Primary study design	Interventional
Study design	Multi-centre, randomised, double-blind, efficacy and safety study
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase II/III
Drug / device / biological / vaccine name(s)	Topical formulations of methotrexate (MQX-5902, MQX-5904 and MQX-5906)
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
Key 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.
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Royal National Hospital for Rheumatic Diseases

Bath
BA1 1RL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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