OnychomycosisPhase 3NCT01145807
TDT 067 Onychomycosis Study
A Phase 3 study testing TDT067 and Transfersome in people with Onychomycosis, run by Celtic Pharma Development Services at 1 site in United States.
Trial summary
The aim of this study is to establish the efficacy, clinical benefits, and safety of treatment with TDT 067 for clinically diagnosed distal subungual onychomycosis of the toenails caused by dermatophytes confirmed by positive mycology. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- TDT067 and Transfersome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 738 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Aug 2012
- Phase
- Phase 3
- 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
- Patients must be between 18 and 75 years of age inclusive, of any race, and of either sex.
- Female patients must be either surgically sterile, postmenopausal (no menses for the previous 12 months), or must be practicing an effective method of birth control as determined by the Investigator.
- Patients must have at least 1 great toenail (target toenail) with clinically diagnosed distal subungual onychomycosis involving between 25% and 65%, inclusive, of the nail and confirmed by KOH visualization and fungal culture positive for dermatophytes. (Patients with culture positive for dermatophytes alone or dermatophytes and non dermatophytes are eligible to participate.) If both great toenails meet inclusion criteria, the one with the greater involvement will be designated the target nail.
- Patients must be able to understand the requirements of the study, abide by the restrictions, and return for all of the required examinations.
- Patients must be willing to sign a statement of informed consent.
- Patients must have a target great toenail with the capability to grow as determined by history of nail cutting.
- Patients must be willing to refrain from using any nail polish products and other nail cosmetic products on any of the toenails and must be willing to refrain from professional pedicures for the duration of this study.
Who cannot join
- Patients who have been treated with an investigational drug within 1 month prior to study start.
- Patients who are pregnant or planning to become pregnant or who are lactating.
- Patients with hypersensitivity to terbinafine or to any other ingredients of the formulation.
- Patients who are unable to spray their toenails and the surrounding tissues on the affected foot without assistance.
- Patients with symptomatic tinea pedis requiring treatment.
- Patients using oral terbinafine within 6 months prior to the start of study; patients who have received other oral antifungals within 3 months.
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- Patients using topical antifungal treatments for onychomycosis within 1 month prior to the start of study; patients using topical antifungal treatments for the feet within 1 month prior to the start of the study.
- Patients with any nail dystrophy that will interfere with the assessment of a clear nail. Patients who have toenail abnormalities or dystrophies that could prevent the restoration of a normal appearing nail in spite of a mycological cure for dermatophytes, including patients with psoriasis, lichen planus, malignancy or pigmentation disorders involving the nail unit, chemical damage, or onychodystrophy due to trauma or other structural deformities.
- Patients with superficial white or proximal subungual onychomycosis.
- Patients with a toenail infection involving a non dermatophyte alone.
- Patients with involvement of the matrix (lunula) or the proximal 2 mm of nail as measured from the proximal nail fold.
- Patients who have a nail plate with thickness greater than 2 mm or total thickness of the nail plus subungual debris measuring greater than 3 mm.
- Patients with yellow streaks or dermatophytoma of the target toenail.
- Patients with a history of peripheral arterial disease or diabetes mellitus.
- Patients with any condition that in the opinion of the Investigator renders the patient unsuitable for participation in this study.
- Patients with alanine aminotransferase (ALT) or aspartate (AST) levels greater than 2 times the upper limit of normal without clinical reason, unless, in the opinion of the Investigator, participation in this study would not place the patient at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
Academic Dermatology Associates
Albequerque, New Mexico, 87106
About this study
Official title: A Randomized, Double-blind, Vehicle- and Placebo-Controlled, Multicenter Trial in Patients With Mild to Moderate Distal Subungual Toenail Onychomycosis to Investigate the Efficacy, Tolerability, and Safety of Twice Daily Application of TDT 067 for 48 Weeks
The aim of this study is to establish the efficacy, clinical benefits, and safety of treatment with TDT 067 for clinically diagnosed distal subungual onychomycosis of the toenails caused by dermatophytes confirmed by positive mycology.
- Conditions
- Onychomycosis
- Being tested
- TDT067, Placebo, Transfersome
- Keywords
- Distal Subungual Toenail Onychomycosis
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDT067Drug
Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application.
PlaceboDrug
Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application.
TransfersomeDrug
Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | non Transfersome® placebo Receives: Drug: Placebo |
| Transfersome® vehicle | Sham comparator | Transfersome® vehicle Receives: Drug: Transfersome |
| TDT 067 | Experimental | TDT 067 Receives: Drug: TDT067 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rate
To compare complete cure rates for onychomycosis at Week 52 for TDT 067 versus non-Transfersome placebo.
If the comparison between TDT 067 and non-Transfersome placebo is statistically significant in favor of TDT 067, the following additional primary efficacy objective:
To compare onychomycosis cure rates at Week 52 for TDT 067 versus Transfersome vehicle
Measured: 52 Weeks
Secondary outcomes (3)
Cure Rate 48
Compare onychomycosis complete cure rates at Wk 48 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare effective treatment rates at Wk 48 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare mycological cure rates at Wk 48 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare complete cure rates at Wk 48 effective treatment rates at Wks 48, and mycological cure rates at Wks 48 for Transfersome® vehicle versus non Transfersome® placebo
Measured: 48 Weeks
Cure Rate 52
Compare onychomycosis complete cure rates at Wk 52 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare effective treatment rates at Wk 52 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare mycological cure rates at Wk 52 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare complete cure rates at Wk 52 effective treatment rates at Wk 52 and mycological cure rates at Wk 52 for Transfersome® vehicle versus non Transfersome® placebo
Measured: 52 Weeks
Cure Rate 60
Compare onychomycosis complete cure rates at Wk 60 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare effective treatment rates at Wk 60 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare mycological cure rates at Wk 60 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare complete cure rates at Wk 60, effective treatment rates at Wk 60, and mycological cure rates at Wk 60 for Transfersome® vehicle versus non Transfersome® placebo
Measured: 60 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2012
- Study completionAug 2012 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 738 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celtic Pharma Development Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Eduardo Tschen, MD, Principal investigator, Academic Dermatology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145807
- Sponsor's protocol ID
- CL-067-III-01
- Status last verified
- Jul 2012
- First submitted
- 19 Mar 2010
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle- and Placebo-Controlled, Multicenter Trial in Patients With Mild to Moderate Distal Subungual Toenail Onychomycosis to Investigate the Efficacy, Tolerability, and Safety of Twice Daily Application of TDT 067 for 48 Weeks
- ClinicalTrials.gov ID
- NCT01145807
- Acronym / sponsor ID
- CL-067-III-01
- Conditions
- Onychomycosis
- Keywords
- Distal Subungual Toenail Onychomycosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 738 participants (estimated)
- Lead sponsor
- Celtic Pharma Development ServicesIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Apr 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (estimated)
- First posted
- 17 Jun 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 aim of this study is to establish the efficacy, clinical benefits, and safety of treatment with TDT 067 for clinically diagnosed distal subungual onychomycosis of the toenails caused by dermatophytes confirmed by positive mycology.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebonon Transfersome® placebo |
| Transfersome® vehicle | Sham comparator | Drug: TransfersomeTransfersome® vehicle |
| TDT 067 | Experimental | Drug: TDT067TDT 067 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must be between 18 and 75 years of age inclusive, of any race, and of either sex.
- Female patients must be either surgically sterile, postmenopausal (no menses for the previous 12 months), or must be practicing an effective method of birth control as determined by the Investigator.
- Patients must have at least 1 great toenail (target toenail) with clinically diagnosed distal subungual onychomycosis involving between 25% and 65%, inclusive, of the nail and confirmed by KOH visualization and fungal culture positive for dermatophytes. (Patients with culture positive for dermatophytes alone or dermatophytes and non dermatophytes are eligible to participate.) If both great toenails meet inclusion criteria, the one with the greater involvement will be designated the target nail.
- Patients must be able to understand the requirements of the study, abide by the restrictions, and return for all of the required examinations.
- Patients must be willing to sign a statement of informed consent.
Key exclusion criteria (16 listed)
- Patients who have been treated with an investigational drug within 1 month prior to study start.
- Patients who are pregnant or planning to become pregnant or who are lactating.
- Patients with hypersensitivity to terbinafine or to any other ingredients of the formulation.
- Patients who are unable to spray their toenails and the surrounding tissues on the affected foot without assistance.
- Patients with symptomatic tinea pedis requiring 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 |
|---|---|---|
| TDT067Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application. | Drug | TDT 067 |
| PlaceboStudy treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application. | Drug | Placebo |
| TransfersomeStudy treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application. | Drug | Transfersome® vehicle |
Primary outcome
Cure Rate
Time frame: 52 Weeks
To compare complete cure rates for onychomycosis at Week 52 for TDT 067 versus non-Transfersome placebo. If the comparison between TDT 067 and non-Transfersome placebo is statistically significant in favor of TDT 067, the following additional primary efficacy objective: To compare onychomycosis cure rates at Week 52 for TDT 067 versus Transfersome vehicle
3 secondary outcomes
Cure Rate 48
Time frame: 48 Weeks
Cure Rate 52
Time frame: 52 Weeks
Cure Rate 60
Time frame: 60 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
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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.
Eduardo Tschen, MD principal investigator
Academic Dermatology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TDT067 and Transfersome in people with Onychomycosis, run by Celtic Pharma Development Services at 1 site 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 16 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 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Cure Rate (time frame: 52 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 1 Aug 2012.