NCT00666354

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
83

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 10, 2009

Status Verified

February 1, 2009

Enrollment Period

11 months

First QC Date

April 22, 2008

Last Update Submit

February 9, 2009

Conditions

Fingernail Psoriasis

Keywords

Nail PsoriasisPsoriasisFingernail PsoriasisMethotrexate

Outcome Measures

Primary Outcomes (1)

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

    Monthly

Secondary Outcomes (4)

  • 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.

    Monthly

  • Information on the relative changes in nail psoriasis severity of the other affected fingernails will be collected.

    Monthly

  • Comparison of nail growth of the target and control fingernails as determined from nail notch movement measured on nail photographs will be performed.

    Monthly

  • 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.

    Monthly

Study Arms (3)

1

ACTIVE COMPARATOR
Drug: Methotrexate

2

ACTIVE COMPARATOR
Drug: Methotrexate

3

ACTIVE COMPARATOR
Drug: Methotrexate

Interventions

MethotrexateDRUG

0.01 gram of topical amphimatrix containing 0.05% methotrexate per affected nail and adjacent skin folds applied daily for three months.

Also known as: MQX-5906
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Manchester, The Dermatology Centre

Salford, Manchester, M6 8HD, United Kingdom

Location

Great Western Hospital Rheumatology Department

Swindon, Wiltshire, SN3 6BB, United Kingdom

Location

Aberdeen Royal Infirmary Dermatology Outpatients Clinic

Aberdeen, AB25 2ZR, United Kingdom

Location

Royal National Hospital for Rheumatic Diseases

Bath, BA1 1RL, United Kingdom

Location

University Hospital of Wales, Welsh Institute of Dermatology

Cardiff, CF14 4XN, United Kingdom

Location

Leeds General Infirmary Department of Dermatology

Leeds, LS1 3EX, United Kingdom

Location

George Eliot Hospital, Department of Dermatology

Nuneaton, CV10 7DJ, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Prof. Neil McHugh

    Royal National Hospital for Rheumatic Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

October 1, 2007

Primary Completion

September 1, 2008

Study Completion

January 1, 2009

Last Updated

February 10, 2009

Record last verified: 2009-02

Locations

GB(7)