Fingernail PsoriasisPhase 2NCT00666354
Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis
A Phase 2 study testing Methotrexate in people with Fingernail Psoriasis, run by MediQuest Therapeutics at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fingernail Psoriasis
- What is being tested?
- Methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Oct 2007to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Aberdeen Royal Infirmary Dermatology Outpatients Clinic
Aberdeen, AB25 2ZR
Royal National Hospital for Rheumatic Diseases
Bath, BA1 1RL
University Hospital of Wales, Welsh Institute of Dermatology
Cardiff, CF14 4XN
Leeds General Infirmary Department of Dermatology
Leeds, LS1 3EX
George Eliot Hospital, Department of Dermatology
Nuneaton, CV10 7DJ
University of Manchester, The Dermatology Centre
Salford, Manchester, M6 8HD
Great Western Hospital Rheumatology Department
Swindon, Wiltshire, SN3 6BB
About this 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
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.
Read the 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.
- Conditions
- Fingernail Psoriasis
- Being tested
- Methotrexate
- Keywords
- Nail Psoriasis, Psoriasis, Fingernail Psoriasis, Methotrexate
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called MQX-5906
0.01 gram of topical amphimatrix containing 0.05% methotrexate per affected nail and adjacent skin folds applied daily for three months.
MethotrexateDrug
Also called MQX-5902
0.01 gram of topical amphimatrix containing 0.25% methotrexate per affected nail and adjacent skin folds applied daily for three months.
MethotrexateDrug
Also called MQX-5904
0.01 gram of topical amphimatrix containing 1.0% methotrexate per affected nail and adjacent skin folds applied daily for three months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Methotrexate |
| 2 | Active comparator | Not described Receives: Drug: Methotrexate |
| 3 | Active comparator | Not described Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators.
Measured: 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.
Measured: Monthly
Information on the relative changes in nail psoriasis severity of the other affected fingernails will be collected.
Measured: Monthly
Comparison of nail growth of the target and control fingernails as determined from nail notch movement measured on nail photographs will be performed.
Measured: 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.
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startOct 2007
- Primary completionSep 2008 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fingernail PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediQuest Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Prof. Neil McHugh, Principal investigator, Royal National Hospital for Rheumatic Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666354
- Sponsor's protocol ID
- 06-003
- Other IDs
- ISRCTN62739763
- Status last verified
- Feb 2009
- First submitted
- 22 Apr 2008
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00666354
- Acronym / sponsor ID
- 06-003
- Conditions
- Fingernail Psoriasis
- Keywords
- Nail Psoriasis, Psoriasis, Fingernail Psoriasis, Methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- MediQuest TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Methotrexate |
| 2 | Active comparator | Drug: Methotrexate |
| 3 | Active comparator | Drug: Methotrexate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAlso: MQX-59060.01 gram of topical amphimatrix containing 0.05% methotrexate per affected nail and adjacent skin folds applied daily for three months. | Drug | 1 |
| MethotrexateAlso: MQX-59020.01 gram of topical amphimatrix containing 0.25% methotrexate per affected nail and adjacent skin folds applied daily for three months. | Drug | 2 |
| MethotrexateAlso: MQX-59040.01 gram of topical amphimatrix containing 1.0% methotrexate per affected nail and adjacent skin folds applied daily for three months. | Drug | 3 |
Primary outcome
Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators.
Time frame: Monthly
4 secondary outcomes
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
Information on the relative changes in nail psoriasis severity of the other affected fingernails will be collected.
Time frame: Monthly
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Neil McHugh principal investigator
Royal National Hospital for Rheumatic Diseases
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate in people with Fingernail Psoriasis, run by MediQuest Therapeutics at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators. (time frame: Monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2009.