Condition category
Skin and Connective Tissue Diseases
Date applied
11/04/2008
Date assigned
24/04/2008
Last edited
27/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Neil McHugh

ORCID ID

Contact details

Royal National Hospital for Rheumatic Diseases
Upper Borough Walls
Bath
BA1 1RL
United Kingdom

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 measures

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

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

http://www.mqti.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/04/2016: No publications found, verifying study status with principal investigator