Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis
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
1 other identifier
interventional
56
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 3, 2008
CompletedFirst Posted
Study publicly available on registry
June 5, 2008
CompletedJune 5, 2008
June 1, 2008
4 months
June 3, 2008
June 3, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
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.
3, 7, 14, 21 and 28 days and Day 35
Study Arms (4)
Group 1
EXPERIMENTAL0% Terbinafine HCl Nail Lacquer for 28 days.
Group 2
EXPERIMENTAL10% Terbinafine HCl Nail Lacquer.
Group 3
ACTIVE COMPARATOR1% Lamisil® Cream
Group 4
ACTIVE COMPARATORDose of 250 mg Lamisil® Tablets (Groups 1,2,3) at end of study.
Interventions
10% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.
Terbinafine tablet, 250mg, single dose in groups 1,2 and 3 at end of study.
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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;
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TKL Research Inc.
Paramus, New Jersey, 07652, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ming Q Lu, MD., Ph.D.
NexMed (U.S.A.), Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 3, 2008
First Posted
June 5, 2008
Study Start
February 1, 2005
Primary Completion
June 1, 2005
Study Completion
December 1, 2005
Last Updated
June 5, 2008
Record last verified: 2008-06