Onychomycosis/Onycholysis and Tinea PedisPhase 1NCT00691184

Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis

A Phase 1 study testing Terbinafine Hydrochloride and Terbinafine in people with Onychomycosis/Onycholysis and Tinea Pedis, run by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.) 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

In this study, the safety and pharmacokinetics of 10 % terbinafine hydrogen chloride (HCl) nail lacquer wre investigated by comparison with vehicle control and 1% terbinafine cream Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Onychomycosis/Onycholysis and Tinea Pedis
What is being tested?: Terbinafine Hydrochloride and Terbinafine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteUnited States
Study dates: Feb 2005to Dec 2005
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients were required to meet all of the following criteria in order to be eligible for entry in the study:
Were between 18 and 70 years of age, of any race and of either sex;
Were in good general health as confirmed by a medical history and brief physical examination;
Groups 1 and 2, presented with clinically diagnosed stable or exacerbating onychomycosis with more than 25 % involvement of one great toenail;
For Group 3, had mild tinea pedis (mild tinea pedis was defined as mild erythema, mild scaling, cracking or fissuring, and mild burning or pruritus);
For Groups 1 and 2, had at least five toenails with onycholysis;

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For Groups 1 and 2, a positive calcofluor (KOH) exam must have been obtained during Visit 1 from specimens taken from the affected great toenail;
Signed a statement of informed consent;
Were able to understand the requirements of the study, abide by the restrictions, and return for all of the required examinations;
If female, met one of the following criteria: (a) had been post-menopausal for at least one year, or (b) had a hysterectomy or tubal ligation, or (c) was using oral/systemic contraceptives or an intrauterine device at least 28 days prior to study entry and throughout the study, or (d) agreed to use spermicide in combination with barrier methods of contraception throughout the study;
Had 10 toes with nails that could be clipped to provide nail samples.

Who cannot join

Any of the following excluded a patient from participating in the study:
Any missing toes;
Known hypersensitivity to terbinafine or any of the excipients in the nail lacquer;
Vital signs measurement that were clinically significantly outside the normal limits;
Liver function test values more than two times the upper limit of normal or other clinical laboratory values, which were clinically significantly outside normal limits;
Receipt of terbinafine tablets within 12 months or terbinafine cream or solution within six months prior to screening;

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Participation in a clinical trial for the systemic treatment of onychomycosis within the previous two months;
Current treatment with rifampin, phenobarbital, phenytoin, carbamazepine, terfenadine, or digoxin;
Prior treatment with an investigational drug within one month prior to study start;
Diagnosis of psoriasis or history of psoriasis;
Diagnosis of a serious concurrent disease that might prevent completion of the trial;
Pregnancy (confirmed by pregnancy test), or plan to become pregnant within the study period or nursing;
Inability to read, understand, or sign the informed consent form or the patient instructions for applying and removing the study formulations;
Inability to apply the study medication;
Onychomycosis patient unwilling to provide nail clippings;
Inability to provide adequate blood sample;
Use of any nail polish products or other nail cosmetic products within seven days prior to the start of treatment, or unwilling to discontinue use of these products during the course of this study.
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

TKL Research Inc.
Paramus, New Jersey, 07652

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Parallel Design Study To Assess the Safety and Pharmacokinetics of Terbinafine Hydrogen Cloride (HCl) Nail Lacquer Applied for 28 Days in Patients With Onychomycosis

In this study, the safety and pharmacokinetics of 10 % terbinafine hydrogen chloride (HCl) nail lacquer wre investigated by comparison with vehicle control and 1% terbinafine cream

Read the detailed description

This was a double-blind, randomized, parallel-design, placebo-controlled Phase 1 study comparing 10% Terbinafine HCl Nail Lacquer vs. Placebo Nail Lacquer (i.e., vehicle control). For comparative purposes, the study also included a contemporaneous assessment of 1% Lamisil® Cream (1% terbinafine HCl) and Lamisil® Tablets (terbinafine HCl labeled as 250 mg of terbinafine).

Forty (40) onychomycosis (Groups 1 and 2) and 16 tinea pedis (Group 3) patients were enrolled at 3 study centers. In Group 1, 10% Terbinafine HCl Nail Lacquer, and, in Group 2, its vehicle (0% terbinafine HCl), were applied topically by brushing on a dose volume of approximately 10 μL per nail twice daily for 28 days to each toenail and to 5 mm of adjacent skin. The patients visited the study center on Days 3, 7, 14, 21, and 28 for assessments of clinical signs and to obtain blood samples. In addition, a 24-hour urine sample was collected and assessed on Day 28 and Day 35. Fifty six (56) patients (20 in Group 1, 20 in Group 2, and 16 in Group 3) received a single oral dose of a 250 mg Lamisil® Tablet after a 7-day washout period.

For comparative purposes, the study also evaluated the local and systemic safety, and plasma levels of terbinafine, and its 3 major metabolites (i.e., desmethyl terbinafine, carboxybutyl terbinafine, and desmethyl carboxybutyl terbinafine) following administration of 1% Lamisil® Cream in comparison with 10% Terbinafine HCl Nail Lacquer. In Group 3, approximately 0.5 g of 1% Lamisil® Cream was applied twice a day for 7 days to the area of the foot affected with tinea pedis. The patients visited the study center on Day 3 and on Day 7 for assessments of clinical signs and collection of blood samples. A 24-hour urine sample was collected and assessed on Day 7 and Day 14.

Conditions: Onychomycosis/Onycholysis and Tinea Pedis
Being tested: Placebo, Terbinafine Hydrochloride, Terbinafine
Keywords: Onychomycosis, Toenail fungal infection, Terbinafine HCl, Pharmacokinetics
Medical subject headings: Onychomycosis, Onycholysis, Tinea Pedis

What participants receive

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

PlaceboDrug
0% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.
Terbinafine HydrochlorideDrug
10% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.
Terbinafine HydrochlorideDrug
Also called Lamisil® Cream, 1%
1% Terbinafine Hydrochloride Cream, twice a day for 7 days.
TerbinafineDrug
Also called Lamisil, 250mg tablet
Terbinafine tablet, 250mg, single dose in groups 1,2 and 3 at end of study.

Study groups in NCT00691184
Study group	Role	What they receive
Group 1	Experimental	0% Terbinafine HCl Nail Lacquer for 28 days. Receives: Drug: Placebo
Group 2	Experimental	10% Terbinafine HCl Nail Lacquer. Receives: Drug: Terbinafine Hydrochloride
Group 3	Active comparator	1% Lamisil® Cream Receives: Drug: Terbinafine Hydrochloride
Group 4	Active comparator	Dose of 250 mg Lamisil® Tablets (Groups 1,2,3) at end of study. Receives: Drug: Terbinafine

What is being measured

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

The primary safety objective was to determine the safety of 10% Terbinafine HCl Nail Lacquer by assessing local and systemic adverse experiences, changes in vital signs, clinical laboratory test results, physical examinations, and electrocardiogram (ECG)
Measured: 28 Days

Secondary outcomes (1)

To determine plasma levels of terbinafine and its metabolites after administration of 10% Terbinafine HCl Nail Lacquer to toenails, 1% Lamisil® Cream to the infected (i.e., tinea pedis) area of the foot and a single Lamisil® Tablet (250 mg) on Day 35.
Measured: 3, 7, 14, 21 and 28 days and Day 35

Timeline

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

Feb 2005Dec 2005

First posted5 Jun 2008 (estimated)
Study startFeb 2005
Primary completionJun 2005
Study completionDec 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Onychomycosis/Onycholysis and Tinea PedisStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00691184
Sponsor's protocol ID: NM-060-1001
Status last verified: Jun 2008
First submitted: 3 Jun 2008
Last updated: 5 Jun 2008
Results posted: No

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Parallel Design Study To Assess the Safety and Pharmacokinetics of Terbinafine Hydrogen Cloride (HCl) Nail Lacquer Applied for 28 Days in Patients With Onychomycosis
ClinicalTrials.gov ID: NCT00691184
Acronym / sponsor ID: NM-060-1001
Conditions: Onychomycosis/Onycholysis and Tinea Pedis
Keywords: Onychomycosis, Toenail fungal infection, Terbinafine HCl, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)Industry (pharma, biotech, devices)
Study start: Feb 2005
Primary completion: Jun 2005 (actual)
Study completion: Dec 2005 (actual)
First posted: 5 Jun 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.

In this study, the safety and pharmacokinetics of 10 % terbinafine hydrogen chloride (HCl) nail lacquer wre investigated by comparison with vehicle control and 1% terbinafine cream

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group 1	Experimental	Drug: Placebo0% Terbinafine HCl Nail Lacquer for 28 days.
Group 2	Experimental	Drug: Terbinafine Hydrochloride10% Terbinafine HCl Nail Lacquer.
Group 3	Active comparator	Drug: Terbinafine Hydrochloride1% Lamisil® Cream
Group 4	Active comparator	Drug: TerbinafineDose of 250 mg Lamisil® Tablets (Groups 1,2,3) at end of study.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Patients were required to meet all of the following criteria in order to be eligible for entry in the study:
Were between 18 and 70 years of age, of any race and of either sex;
Were in good general health as confirmed by a medical history and brief physical examination;
Groups 1 and 2, presented with clinically diagnosed stable or exacerbating onychomycosis with more than 25 % involvement of one great toenail;
For Group 3, had mild tinea pedis (mild tinea pedis was defined as mild erythema, mild scaling, cracking or fissuring, and mild burning or pruritus);

Key exclusion criteria (18 listed)

Any missing toes;
Known hypersensitivity to terbinafine or any of the excipients in the nail lacquer;
Vital signs measurement that were clinically significantly outside the normal limits;
Liver function test values more than two times the upper limit of normal or other clinical laboratory values, which were clinically significantly outside normal limits;
Receipt of terbinafine tablets within 12 months or terbinafine cream or solution within six months prior to screening;

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
Placebo0% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.	Drug	Group 1
Terbinafine Hydrochloride10% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.	Drug	Group 2
Terbinafine HydrochlorideAlso: Lamisil® Cream, 1%1% Terbinafine Hydrochloride Cream, twice a day for 7 days.	Drug	Group 3
TerbinafineAlso: Lamisil, 250mg tabletTerbinafine tablet, 250mg, single dose in groups 1,2 and 3 at end of study.	Drug	Group 4

Primary outcome

The primary safety objective was to determine the safety of 10% Terbinafine HCl Nail Lacquer by assessing local and systemic adverse experiences, changes in vital signs, clinical laboratory test results, physical examinations, and electrocardiogram (ECG)
Time frame: 28 Days

1 secondary outcome

To determine plasma levels of terbinafine and its metabolites after administration of 10% Terbinafine HCl Nail Lacquer to toenails, 1% Lamisil® Cream to the infected (i.e., tinea pedis) area of the foot and a single Lamisil® Tablet (250 mg) on Day 35.
Time frame: 3, 7, 14, 21 and 28 days and Day 35

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 5 Jun 2008.

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.

Ming Q Lu, MD., Ph.D. study director

NexMed (U.S.A.), Inc.

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

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 18 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 5 Jun 2008. 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?

The primary safety objective was to determine the safety of 10% Terbinafine HCl Nail Lacquer by assessing local and systemic adverse experiences, changes in vital signs, clinical laboratory test results, physical examinations, and electrocardiogram (ECG) (time frame: 28 Days). 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 NCT00691184.

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 5 Jun 2008.