Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis - Full Text View

Sponsor:	MediQuest Therapeutics
Information provided by:	MediQuest Therapeutics
ClinicalTrials.gov Identifier:	NCT00666354

Purpose

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.

Condition	Intervention	Phase
Fingernail Psoriasis	Drug: Methotrexate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Methotrexate

U.S. FDA Resources

Further study details as provided by MediQuest Therapeutics:

Primary Outcome Measures:

Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators. [ Time Frame: Monthly ] [ Designated as safety issue: No ]

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. [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Information on the relative changes in nail psoriasis severity of the other affected fingernails will be collected. [ Time Frame: Monthly ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	83
Study Start Date:	October 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Methotrexate 0.01 gram of topical amphimatrix containing 0.05% methotrexate per affected nail and adjacent skin folds applied daily for three months.
2: Active Comparator	Drug: Methotrexate 0.01 gram of topical amphimatrix containing 0.25% methotrexate per affected nail and adjacent skin folds applied daily for three months.
3: Active Comparator	Drug: Methotrexate 0.01 gram of topical amphimatrix containing 1.0% methotrexate per affected nail and adjacent skin folds applied daily for three months.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666354

Locations

United Kingdom
Royal National Hospital for Rheumatic Diseases
Bath, United Kingdom, BA1 1RL
University Hospital of Wales, Welsh Institute of Dermatology
Cardiff, United Kingdom, CF14 4XN
Leeds General Infirmary Department of Dermatology
Leeds, United Kingdom, LS1 3EX
Aberdeen Royal Infirmary Dermatology Outpatients Clinic
Aberdeen, United Kingdom, AB25 2ZR
George Eliot Hospital, Department of Dermatology
Nuneaton, United Kingdom, CV10 7DJ
United Kingdom, Manchester
University of Manchester, The Dermatology Centre
Salford, Manchester, United Kingdom, M6 8HD
United Kingdom, Wiltshire
Great Western Hospital Rheumatology Department
Swindon, Wiltshire, United Kingdom, SN3 6BB

Sponsors and Collaborators

MediQuest Therapeutics

Investigators

Principal Investigator:

Prof. Neil McHugh

Royal National Hospital for Rheumatic Diseases

More Information

No publications provided

Responsible Party:	MediQuest Therapeutics ( Fred Dechow/President and CEO )
Study ID Numbers:	06-003, ISRCTN62739763
Study First Received:	April 22, 2008
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00666354 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by MediQuest Therapeutics:

Nail Psoriasis
Psoriasis
Fingernail Psoriasis
Methotrexate

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal

Immunosuppressive Agents
Pharmacologic Actions
Psoriasis
Therapeutic Uses
Abortifacient Agents
Methotrexate
Antirheumatic Agents
Dermatologic Agents
Skin Diseases, Papulosquamous
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 25, 2009