Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00666354
Protocol/serial number
06-003
Study information
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
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
South West Research Ethics Committee, 17/04/2007, ref: 07/MRE06/25
Study design
Multi-centre, randomised, double-blind, efficacy and safety study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
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 trial start date
01/10/2007
Overall trial end date
01/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
83
Participant 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
Recruitment start date
01/10/2007
Recruitment end date
01/01/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal National Hospital for Rheumatic Diseases
Bath
BA1 1RL
United Kingdom
Sponsor information
Organisation
MediQuest Therapeutics, Inc. (USA)
Sponsor details
22322 20th Ave. S.E.
Suite 100
Bothell
98021
United States of America
+1 425 398 9580
info@mqti.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
MediQuest Therapeutics, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list