OnychomycosisPhase 2NCT00253305
Topical Gel Anti-Fungal Agent for Tinea Unguium
A Phase 2 study testing Organogel of naftifine, 2%, Organogel of terbinafine, 2% and Organogel of naftifine, 6% in people with Onychomycosis, run by MediQuest Therapeutics at 5 sites in United States.
Trial summary
The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Organogel of naftifine, 2%, Organogel of terbinafine, 2% and Organogel of naftifine, 6%
- How many people
- 75 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2005to not given
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of distal subungual tinuea unguium of one great toenail.
- between 20 - 65% infected area for target nail
- 2 mm of clear nail proximally on target nail
- positive dermatophyte culture and positive KOH test
- able to sign informed consent
- understand requirements of study
- females must be post-menopausal or agree to use approved contraceptives throughout the study
Who cannot join
- patients with nails infected with organisms other than dermatophytes
- patients with proximal subungual tinea unguium
- patients with spikes of disease extending to nail matrix
- patients with more than 5 infected nails
- patients with confounding problems/ abnormalities of target nail
- patients with screening lab values more than 20% of normal
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- patients with known hypersensitivity to test material components
- patients requiring systemic medications that may interfere with study
- patients with a poor history of compliance with study requirements
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Greater Miami Skin and Laser Center
Miami Beach, Florida, 33140
Northwest Cutaneous research
Portland, Oregon, 97210
Washington University
St Louis, Missouri, 63110
Genova Clinical Research, Inc.
Tucson, Arizona, 85741
About this study
Official title: Phase IIB Efficacy and Safety Study of Four Topical Gel Formulations of Anti-Fungal Agents, MQX-5858, MQX-5859, MQX-5866, and MQX-5867, Versus Vehicle in the Treatment of Tinea Unguium.
The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis).
The formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety.
Once the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.
- Conditions
- Onychomycosis
- Being tested
- Organogel of naftifine, 2%, Organogel of terbinafine, 2%, Organogel of naftifine, 6%, Organogel of terbinafine, 6%
- Keywords
- tinea unguium, onychomycosis
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organogel of naftifine, 2%Drug
Organogel of terbinafine, 2%Drug
Organogel of naftifine, 6%Drug
Organogel of terbinafine, 6%Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Quanitative improvement in toenail appearance.
Assessment of dermatophyte culture and KOH examination.
Frequency and severity of adverse events.
Secondary outcomes (3)
Time to achieve 90% and 100% clearance of fungus from nail.
Assessment of treatment success.
Assessment of mycological success.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies 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
- Single group
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- MediQuest Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253305
- Sponsor's protocol ID
- MQT-05-001
- Status last verified
- May 2007
- First submitted
- 13 Nov 2005
- Last updated
- 30 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIB Efficacy and Safety Study of Four Topical Gel Formulations of Anti-Fungal Agents, MQX-5858, MQX-5859, MQX-5866, and MQX-5867, Versus Vehicle in the Treatment of Tinea Unguium.
- ClinicalTrials.gov ID
- NCT00253305
- Acronym / sponsor ID
- MQT-05-001
- Conditions
- Onychomycosis
- Keywords
- tinea unguium, onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- MediQuest TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- First posted
- 15 Nov 2005 (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 study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis).
The formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety.
Once the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- clinical diagnosis of distal subungual tinuea unguium of one great toenail.
- between 20 - 65% infected area for target nail
- 2 mm of clear nail proximally on target nail
- positive dermatophyte culture and positive KOH test
- able to sign informed consent
Key exclusion criteria (9 listed)
- patients with nails infected with organisms other than dermatophytes
- patients with proximal subungual tinea unguium
- patients with spikes of disease extending to nail matrix
- patients with more than 5 infected nails
- patients with confounding problems/ abnormalities of target nail
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 |
|---|---|---|
| Organogel of naftifine, 2% | Drug | – |
| Organogel of terbinafine, 2% | Drug | – |
| Organogel of naftifine, 6% | Drug | – |
| Organogel of terbinafine, 6% | Drug | – |
Primary outcome
Quanitative improvement in toenail appearance.
Assessment of dermatophyte culture and KOH examination.
Frequency and severity of adverse events.
3 secondary outcomes
Time to achieve 90% and 100% clearance of fungus from nail.
Assessment of treatment success.
Assessment of mycological success.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 Organogel of naftifine, 2%, Organogel of terbinafine, 2% and Organogel of naftifine, 6% in people with Onychomycosis, run by MediQuest Therapeutics at 5 sites in United States.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 30 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quanitative improvement in toenail appearance.. The study lists 3 primary outcomes in all. 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 30 May 2007.