Distal Subungual OnychomycosisPhase 2NCT01093118
A Study to Evaluate TMI-358 in the Treatment of Distal Subungual Onychomycosis
A Phase 2 study testing TMI-358 and MMI-467 in people with Distal Subungual Onychomycosis, run by Talima Therapeutics, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to determine if a local treatment is effective for the treatment of toenail fungus (distal subungual onychomycosis). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Distal Subungual Onychomycosis
- What is being tested?
- TMI-358 and MMI-467
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2009to Apr 2011
- 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
- Male or female, 18 to 75 years of age, inclusive
- Diagnosed with distal subungual onychomycosis (DSO) of the toenails
- Great toe(s) with intact skin and intact neurologic functions
- Great toenail(s) free of nail polish
- At least one target great toe which has:
- 25 to 75% involvement of the area of the nail unit (including destroyed or missing parts of the nail plate)
Show all 9Show fewer
- at least 2 mm of uninvolved nail growth as measured from the proximal nail fold to the most proximal point to the disease process and with no lunular involvement
- nail unit hyperkeratosis at the most distal edge which measures no greater than 3 mm
- a positive KOH and culture
Who cannot join
- Any significant disease of the hepatic, renal, endocrine (including diabetes mellitus), immune systems, or other health conditions which could interfere with or confound the results of study assessments
- Pre-existing chronic foot pain, neurologic deficit or skin disease/injury in treated foot
- In the case of female subjects, are pregnant, nursing, or planning to become pregnant within the study period
- History of clinically significant abnormal laboratory values, including liver function test results equal to or greater than 2 x the upper limit of normal
- Disease-like psoriatic toenails, significant toenail abnormalities/dystrophies, toenail injuries or any other condition in the toenail which could interfere with study evaluations (e.g., prevent obtaining normal appearing nail, after clearing of onychomycosis, due to chemical damage, genetic or pigmentary disorders, etc.)
- Have white superficial onychomycosis, proximal subungual onychomycosis, yellow spikes, or dermatophytoma
- Have paronychia
- Have a history of chronic alcohol or drug abuse
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Radiant Research, Inc.
Cincinnati, Ohio, 45249
J&S Studies, Inc.
College Station, Texas, 77845
International Dermatology Research Center
Miami, Florida, 33144
Oregon Medical Research Center
Portland, Oregon, 97223
Dermatology Research Center
Salt Lake City, Utah, 84124
Therapeutics Clinical Research
San Diego, California, 92123
Radiant Research, Inc.
Tucson, Arizona, 85710
About this study
Official title: A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TMI-358 in the Treatment of Distal Subungual Onychomycosis of the Toenail
The purpose of this study is to determine if a local treatment is effective for the treatment of toenail fungus (distal subungual onychomycosis).
- Conditions
- Distal Subungual Onychomycosis
- Being tested
- TMI-358, MMI-467
- Keywords
- Distal subungual onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMI-358Drug
Micro implant monthly x 3
MMI-467Drug
Micro implant monthly x 3
| Study group | Role | What they receive |
|---|---|---|
| TMI-358 | Experimental | Active treatment Receives: Drug: TMI-358 |
| MMI-467 | Placebo comparator | Not described Receives: Drug: MMI-467 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rates
Based on clinical evaluations (nail measurements, KOH, and mycological culture for dermatophytes), cure categories will be defined as either mycological cure, clinical cure, complete cure, or effective treatment.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionApr 2011 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Subungual 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Talima Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Terry Jones, MD, Principal investigator, J&S Studies, Inc.Michael Noss, MD, Principal investigator, Radiant Research, Inc.Robert Matheson, MD, Principal investigator, Oregon Medical Research CenterLeonard Swinyer, MD, Principal investigator, Dermatology Research CenterStacy Smith, MD, Principal investigator, Therapeutics Clinical ResearchNorman Bystol, MD, Principal investigator, Radiant Research, Inc.Jose Mendez, DO, Principal investigator, International Dermatology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093118
- Sponsor's protocol ID
- TCP-TMI-7007
- Status last verified
- Jan 2011
- First submitted
- 23 Mar 2010
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TMI-358 in the Treatment of Distal Subungual Onychomycosis of the Toenail
- ClinicalTrials.gov ID
- NCT01093118
- Acronym / sponsor ID
- TCP-TMI-7007
- Conditions
- Distal Subungual Onychomycosis
- Keywords
- Distal subungual onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Talima Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (estimated)
- First posted
- 25 Mar 2010 (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 determine if a local treatment is effective for the treatment of toenail fungus (distal subungual onychomycosis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMI-358 | Experimental | Drug: TMI-358Active treatment |
| MMI-467 | Placebo comparator | Drug: MMI-467 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, 18 to 75 years of age, inclusive
- Diagnosed with distal subungual onychomycosis (DSO) of the toenails
- Great toe(s) with intact skin and intact neurologic functions
- Great toenail(s) free of nail polish
- At least one target great toe which has:
Key exclusion criteria (8 listed)
- Any significant disease of the hepatic, renal, endocrine (including diabetes mellitus), immune systems, or other health conditions which could interfere with or confound the results of study assessments
- Pre-existing chronic foot pain, neurologic deficit or skin disease/injury in treated foot
- In the case of female subjects, are pregnant, nursing, or planning to become pregnant within the study period
- History of clinically significant abnormal laboratory values, including liver function test results equal to or greater than 2 x the upper limit of normal
- Disease-like psoriatic toenails, significant toenail abnormalities/dystrophies, toenail injuries or any other condition in the toenail which could interfere with study evaluations (e.g., prevent obtaining normal appearing nail, after clearing of onychomycosis, due to chemical damage, genetic or pigmentary disorders, etc.)
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 |
|---|---|---|
| TMI-358Micro implant monthly x 3 | Drug | TMI-358 |
| MMI-467Micro implant monthly x 3 | Drug | MMI-467 |
Primary outcome
Cure rates
Time frame: 48 weeks
Based on clinical evaluations (nail measurements, KOH, and mycological culture for dermatophytes), cure categories will be defined as either mycological cure, clinical cure, complete cure, or effective treatment.
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2011.
Related trials for Distal Subungual Onychomycosis
Recruiting
Safety and Efficacy of Next Science Gel on Toenail Fungus
Onychomycosis of Toenail
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.
Terry Jones, MD principal investigator
J&S Studies, Inc.
Michael Noss, MD principal investigator
Radiant Research, Inc.
Robert Matheson, MD principal investigator
Oregon Medical Research Center
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 TMI-358 and MMI-467 in people with Distal Subungual Onychomycosis, run by Talima Therapeutics, Inc. at 7 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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 Jan 2011. 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 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Business decision). 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?
Cure rates (time frame: 48 weeks). 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 17 Jan 2011.