OnychomycosisPhase 1NCT00768768

Iontophoretic Application of Terbinafine Gel to the Large Toe Nail

A Phase 1 study testing Electrokinetic Transungual System (ETS) - Terbinafine Gel and ETS-Terbinafine Gel in people with Onychomycosis, run by Transport Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Terbinafine is recognized as one of the most effective drugs for the treatment of toe nail fungus (onychomycosis). This trial will be the first test of a new device to improve the delivery of terbinafine directly to the toe nail. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Onychomycosis
What is being tested?: Electrokinetic Transungual System (ETS) - Terbinafine Gel and ETS-Terbinafine Gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Oct 2008to Mar 2009
Phase: Phase 1
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female volunteers between 18 and 75 years of age, inclusive.

Who cannot join

Subjects with pacemakers or automatic implantable cardioverter/defibrillator
Subjects with an implantable electronic device.
Subjects with a history of diabetes.
Subjects with a history of onychomycosis or an abnormal appearing nail on the great toe
Subject using systemic antifungal medications within 6 months prior to study enrollment.
Subject using prescription topical antifungal medications for toenail fungus within 3 months or other commercially available medications for toenail fungus applied directly to the toenail within 1 week prior to study enrollment.

Show all 12Show fewer

Subject with a history of allergic or adverse response to terbinafine or any related anti-fungal drug
Participation in a previous clinical trial involving an investigational drug or device within 30 days prior to study enrollment.
Subject requires chronic use of analgesics, pain medication, or non-steroidal anti-inflammatory agents (NSAIDS).
In females of childbearing potential, a positive urine pregnancy test at screening and just prior to dosing.
Nursing mothers.
Subject with a history of alcoholism or drug abuse within the preceding 12 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cetero Research
Fargo, North Dakota, 58104

Other trials in United States

About this study

Official title: A Study of Skin/Nail Sensation and the Pharmacokinetics of the Uptake of Terbinafine in the Great Toe Nail and Systemically Following Treatment With the Electrokinetic Transungual System (ETS)-Terbinafine Gel in Healthy Normal Voluneteers

The study will involve a single application of terbinafine, in a gel form, with the iontophoretic device. The treatment will be applied to the surface of both large toenails of healthy subjects. Subjects will be asked to report any sensations in the nail or surrounding skin experienced during or after treatment. Samples from the edge of the treated toe nail will be taken at 2-4 week intervals to measure how much terbinafine was delivered to the nails, and blood samples will be taken for the first 24 hours after treatment to determine how much, if any, terbinafine was absorbed into the subjects's body. Observations will also be made of the treated toes to look for any irritation of the surrounding skin due to the treatment.

Conditions: Onychomycosis
Being tested: Electrokinetic Transungual System (ETS) - Terbinafine Gel, ETS-Terbinafine Gel
Keywords: iontophoresis, terbinafine, onychomycosis
Medical subject headings: Onychomycosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electrokinetic Transungual System (ETS) - Terbinafine GelOther
Iontophoresis in conjunction with a terbinafine gel
Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated.
Two different drug applicators to be tested on each subject
Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design
Iontophoretic Dose: 3 mA-min as 0.3 mA for 10 min
ETS-Terbinafine GelOther
Iontophoresis in conjunction with a terbinafine gel
Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated.
Two different drug applicators to be tested on each subject
Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design
Iontophoretic Dose: 6 mA-min as 0.5 mA for 12 min
ETS-Terbinafine GelOther
Iontophoresis in conjunction with a terbinafine gel
Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated.
Two different drug applicators to be tested on each subject
Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design
Iontophoretic Dose: 6 mA-min as 0.3 mA for 20 min
ETS-Terbinafine GelOther
Iontophoresis in conjunction with a terbinafine gel
Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated.
Two different drug applicators to be tested on each subject
Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design
Iontophoretic Dose: 10 mA-min as 0.5 mA for 20 min
ETS-Terbinafine GelOther
Iontophoresis in conjunction with a terbinafine gel
Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated.
Two different drug applicators to be tested on each subject
Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design
Iontophoretic Dose: 15 mA-min as 0.5 mA for 30 min

Study groups in NCT00768768
Study group	Role	What they receive
1	Active comparator	Iontophoretic Dose Level 1 Receives: Other: Electrokinetic Transungual System (ETS) - Terbinafine Gel
2	Active comparator	Iontophoretic Dose Level 2 Receives: Other: ETS-Terbinafine Gel
3	Active comparator	Iontophoretic Dose Level 3 Receives: Other: ETS-Terbinafine Gel
4	Active comparator	Iontophoretic Dose Level 4 Receives: Other: ETS-Terbinafine Gel
5	Active comparator	Iontophoretic Dose Level 5 Receives: Other: ETS-Terbinafine Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the skin/nail sensation noted by subjects during and following iontophoretic application of terbinafine gel to the great toenail
Measured: 12 weeks

Secondary outcomes (1)

Evaluate the uptake into the nail of the great toe and the systemic uptake and pharmacokinetics of terbinafine following a single iontophoretic application of terbinafine gel
Measured: 12 weeks and 24 hours, respectively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Mar 2009

First posted8 Oct 2008 (estimated)
Study startOct 2008
Primary completionJan 2009
Study completionMar 2009

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00768768
Sponsor's protocol ID: TPI-N-111
Status last verified: Mar 2009
First submitted: 6 Oct 2008
Last updated: 12 Mar 2009
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail

All Onychomycosis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Skin/Nail Sensation and the Pharmacokinetics of the Uptake of Terbinafine in the Great Toe Nail and Systemically Following Treatment With the Electrokinetic Transungual System (ETS)-Terbinafine Gel in Healthy Normal Voluneteers
ClinicalTrials.gov ID: NCT00768768
Acronym / sponsor ID: TPI-N-111
Conditions: Onychomycosis
Keywords: iontophoresis, terbinafine, onychomycosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (estimated)
Lead sponsor: Transport PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Jan 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 8 Oct 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
1	Active comparator	Other: Electrokinetic Transungual System (ETS) - Terbinafine GelIontophoretic Dose Level 1
2	Active comparator	Other: ETS-Terbinafine GelIontophoretic Dose Level 2
3	Active comparator	Other: ETS-Terbinafine GelIontophoretic Dose Level 3
4	Active comparator	Other: ETS-Terbinafine GelIontophoretic Dose Level 4
5	Active comparator	Other: ETS-Terbinafine GelIontophoretic Dose Level 5

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Male and female volunteers between 18 and 75 years of age, inclusive.

Key exclusion criteria (12 listed)

Subjects with pacemakers or automatic implantable cardioverter/defibrillator
Subjects with an implantable electronic device.
Subjects with a history of diabetes.
Subjects with a history of onychomycosis or an abnormal appearing nail on the great toe
Subject using systemic antifungal medications within 6 months prior to study enrollment.

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
Electrokinetic Transungual System (ETS) - Terbinafine GelIontophoresis in conjunction with a terbinafine gel Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated. Two different drug applicators to be tested on each subject Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design Iontophoretic Dose: 3 mA-min as 0.3 mA for 10 min	Other	1
ETS-Terbinafine GelIontophoresis in conjunction with a terbinafine gel Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated. Two different drug applicators to be tested on each subject Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design Iontophoretic Dose: 6 mA-min as 0.5 mA for 12 min	Other	2
ETS-Terbinafine GelIontophoresis in conjunction with a terbinafine gel Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated. Two different drug applicators to be tested on each subject Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design Iontophoretic Dose: 6 mA-min as 0.3 mA for 20 min	Other	3
ETS-Terbinafine GelIontophoresis in conjunction with a terbinafine gel Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated. Two different drug applicators to be tested on each subject Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design Iontophoretic Dose: 10 mA-min as 0.5 mA for 20 min	Other	4
ETS-Terbinafine GelIontophoresis in conjunction with a terbinafine gel Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated. Two different drug applicators to be tested on each subject Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design Iontophoretic Dose: 15 mA-min as 0.5 mA for 30 min	Other	5

Primary outcome

Evaluate the skin/nail sensation noted by subjects during and following iontophoretic application of terbinafine gel to the great toenail
Time frame: 12 weeks

1 secondary outcome

Evaluate the uptake into the nail of the great toe and the systemic uptake and pharmacokinetics of terbinafine following a single iontophoretic application of terbinafine gel
Time frame: 12 weeks and 24 hours, respectively

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 12 Mar 2009.

Related trials for Onychomycosis

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail

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.

Craig Sprenger, MD principal investigator

Cetero Research, San Antonio

Eric M Morrel, PhD study director

Transport Pharmaceuticals, Inc.

Philip M Friden, PhD study director

Transport Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Electrokinetic Transungual System (ETS) - Terbinafine Gel and ETS-Terbinafine Gel in people with Onychomycosis, run by Transport Pharmaceuticals 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 1 inclusion and 12 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 12 Mar 2009. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Evaluate the skin/nail sensation noted by subjects during and following iontophoretic application of terbinafine gel to the great toenail (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00768768.

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 12 Mar 2009.