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Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis
This study is ongoing, but not recruiting participants.
Study NCT00666354   Information provided by MediQuest Therapeutics
First Received: April 22, 2008   Last Updated: February 9, 2009   History of Changes

April 22, 2008
February 9, 2009
October 2007
September 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00666354 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis
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

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.

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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Fingernail Psoriasis
Drug: Methotrexate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
83
January 2009
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00666354
Fred Dechow/President and CEO, MediQuest Therapeutics
06-003, ISRCTN62739763
MediQuest Therapeutics
 
Principal Investigator: Prof. Neil McHugh Royal National Hospital for Rheumatic Diseases
MediQuest Therapeutics
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP