search
Back to results

Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis

Primary Purpose

Fingernail Psoriasis

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Methotrexate
Methotrexate
Methotrexate
Sponsored by
MediQuest Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fingernail Psoriasis focused on measuring Nail Psoriasis, Psoriasis, Fingernail Psoriasis, Methotrexate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed moderate fingernail psoriasis of at least two fingernails.
  • Stable and unchanged psoriasis therapies for 2 months and must not have received methotrexate for 3 months prior to screening.
  • Female patients who are not 5 years post menopausal or surgically sterile must use appropriate birth control for specified time periods and have negative pregnancy tests.

Exclusion Criteria:

  • Target or control fingernails that are thicker than 2mm, abnormal or infected (bacterial or fungal).
  • Patients with immunosuppression, HIV, or neuropathies of the hand.
  • Use of any methotrexate preparation, any topical anti-psoriatic medications or ultraviolet treatment within 2 months of study visit 1.
  • Use of more that one 2-week course of oral corticosteroid therapy or one injection during 3 months prior to the screening visit.
  • Use of manicures or cosmetic nail products during and within 7 days of the start of treatment.
  • 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.
  • 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.

Sites / Locations

  • University of Manchester, The Dermatology Centre
  • Great Western Hospital Rheumatology Department
  • Aberdeen Royal Infirmary Dermatology Outpatients Clinic
  • Royal National Hospital for Rheumatic Diseases
  • University Hospital of Wales, Welsh Institute of Dermatology
  • Leeds General Infirmary Department of Dermatology
  • George Eliot Hospital, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators.

Secondary Outcome Measures

Improvement in appearance of the control fingernail, improvement of the target fingernail using mNAPSI (a modification of the Nail Psoriasis Severity Index), and comparison of improvement of mNAPSI of the target and control fingernails.
Information on the relative changes in nail psoriasis severity of the other affected fingernails will be collected.
Comparison of nail growth of the target and control fingernails as determined from nail notch movement measured on nail photographs will be performed.
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.

Full Information

First Posted
April 22, 2008
Last Updated
February 9, 2009
Sponsor
MediQuest Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT00666354
Brief Title
Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis
Official 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 Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2008 (Anticipated)
Study Completion Date
January 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
MediQuest Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this clinical study is to compare the efficacy and safety of three concentrations of topical methotrexate for the treatment of fingernail psoriasis.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fingernail Psoriasis
Keywords
Nail Psoriasis, Psoriasis, Fingernail Psoriasis, Methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
MQX-5906
Intervention Description
0.01 gram of topical amphimatrix containing 0.05% methotrexate per affected nail and adjacent skin folds applied daily for three months.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
MQX-5902
Intervention Description
0.01 gram of topical amphimatrix containing 0.25% methotrexate per affected nail and adjacent skin folds applied daily for three months.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
MQX-5904
Intervention Description
0.01 gram of topical amphimatrix containing 1.0% methotrexate per affected nail and adjacent skin folds applied daily for three months.
Primary Outcome Measure Information:
Title
Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators.
Time Frame
Monthly
Secondary Outcome Measure Information:
Title
Improvement in appearance of the control fingernail, improvement of the target fingernail using mNAPSI (a modification of the Nail Psoriasis Severity Index), and comparison of improvement of mNAPSI of the target and control fingernails.
Time Frame
Monthly
Title
Information on the relative changes in nail psoriasis severity of the other affected fingernails will be collected.
Time Frame
Monthly
Title
Comparison of nail growth of the target and control fingernails as determined from nail notch movement measured on nail photographs will be performed.
Time Frame
Monthly
Title
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.
Time Frame
Monthly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed moderate fingernail psoriasis of at least two fingernails. Stable and unchanged psoriasis therapies for 2 months and must not have received methotrexate for 3 months prior to screening. Female patients who are not 5 years post menopausal or surgically sterile must use appropriate birth control for specified time periods and have negative pregnancy tests. Exclusion Criteria: Target or control fingernails that are thicker than 2mm, abnormal or infected (bacterial or fungal). Patients with immunosuppression, HIV, or neuropathies of the hand. Use of any methotrexate preparation, any topical anti-psoriatic medications or ultraviolet treatment within 2 months of study visit 1. Use of more that one 2-week course of oral corticosteroid therapy or one injection during 3 months prior to the screening visit. Use of manicures or cosmetic nail products during and within 7 days of the start of treatment. 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Neil McHugh
Organizational Affiliation
Royal National Hospital for Rheumatic Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manchester, The Dermatology Centre
City
Salford
State/Province
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Great Western Hospital Rheumatology Department
City
Swindon
State/Province
Wiltshire
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary Dermatology Outpatients Clinic
City
Aberdeen
ZIP/Postal Code
AB25 2ZR
Country
United Kingdom
Facility Name
Royal National Hospital for Rheumatic Diseases
City
Bath
ZIP/Postal Code
BA1 1RL
Country
United Kingdom
Facility Name
University Hospital of Wales, Welsh Institute of Dermatology
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Leeds General Infirmary Department of Dermatology
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
George Eliot Hospital, Department of Dermatology
City
Nuneaton
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis

We'll reach out to this number within 24 hrs