OnychomycosisPhase 3NCT00443898
Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
A Phase 3 study testing terbinafine in people with Onychomycosis, run by Novartis Pharmaceuticals at 22 sites in 3 countries.
Trial summary
This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- terbinafine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 518 participants
- Where
- 22 sitesin 3 countries
- Study dates
- Dec 2006to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and females 12 - 75 years of age
- Fungal toenail infection of one or both of the large (great) toenails
- The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and non-dermatophyte] are not allowed)
Who cannot join
- Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinifine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
- Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
- No administration of systemic antifungal medications within 6 months prior to screening visit
- No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
- No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
- Known pregnancy or lactation at time of enrollment
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United States20 sites
Dr. Harry Penny
Altoona, Pennsylvania, 16602
Dr. Teresa Coats
Austin, Texas, 78705
Dr. Boni Elewski
Birmingham, Alabama, 35233
Dr. John Fenyk
Chaska, Minnesota, 55318
Dr. Scott J. Ashton
Dallas, Texas, 75243
Dr. Amit Pandya
Dallas, Texas, 75390-8802
Dr. James Swinehart
Denver, Colorado, 80210
Dr. Robert Shouey
Harrisonburg, Virginia, 22801
Dr. Diane Baker
Lake Oswego, Oregon, 97035
Dr. Kevin Terry
Lutherville, Maryland, 21093
Dr. Anthony Puopolo
Milford, Massachusetts, 01757
Dr. Cynthia Strout
Mt. Pleasant, South Carolina, 29464
Dr. AnneMarie Uliasz
New York, New York, 10029
Dr. David G. Armstrong
North Chicago, Illinois, 60064
Dr. Joel Schlessinger
Omaha, Nebraska, 68144
Dr. Lawrence Parish
Philadelphia, Pennsylvania, 19103
Dr. John Barnes
Portland, Oregon, 97205
Dr. Willard Niemi
Raleigh, North Carolina, 27615
Dr. Lawrence Harkless
San Antonio, Texas, 78207
Dr. Stacy Smith
San Diego, California, 92123
About this study
Official title: A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Topical Terbinafine Hydrogen Chloride (HCl) Formulation for 24 or 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis
This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.
- Conditions
- Onychomycosis
- Being tested
- terbinafine, Placebo
- Keywords
- Toenail fungus, Onychomycosis, Nail fungus, Toenail fungal infection, Tinea unguium, Dermatophytes, Foot dermatoses
- Medical subject headings
- Onychomycosis, Foot Dermatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terbinafineDrug
Also called Lamisil
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
PlaceboDrug
vehicle (placebo) applied once daily for 48 weeks
terbinafineDrug
Also called Lamisil
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
PlaceboDrug
vehicle (placebo) applied once daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks Receives: Drug: terbinafine |
| 2 | Placebo comparator | vehicle (placebo) applied once daily for 48 weeks Receives: Drug: Placebo |
| 3 | Experimental | Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks Receives: Drug: terbinafine |
| 4 | Placebo comparator | vehicle (placebo) applied once daily for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.
Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes.
and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as "Yes" if:
- Mycological cure (negative KOH and negative culture for dermatophytes) and
- No residual involvement of the target toenail "No" if otherwise
Measured: 52 weeks
Secondary outcomes (3)
Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.
Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.
Mycological cure was a composite binary variable defined as "Yes"if :
- Negative microscopy and
- Negative culture for dermatophytes "No" if otherwise.
Measured: 52 weeks
Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.
Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.
Clinical effectiveness was a composite binary variable defined as "Yes" if
- Mycological cure (negative KOH and negative culture for dermatophytes) and
- = 10% residual involvement of the target toenail "No" if otherwise
Measured: 52 weeks
Number of Participants Assessed With Adverse Events and Serious Adverse Events
An adverse event (AE) is any adverse change in health or side effect that occurs while the participant is receiving the treatment or within a previously specified period of time after the treatment has been completed.
A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening requires, inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startDec 2006
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443898
- Sponsor's protocol ID
- CSFO327N2301
- Status last verified
- May 2012
- First submitted
- 5 Mar 2007
- Last updated
- 3 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Topical Terbinafine Hydrogen Chloride (HCl) Formulation for 24 or 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis
- ClinicalTrials.gov ID
- NCT00443898
- Acronym / sponsor ID
- CSFO327N2301
- Conditions
- Onychomycosis
- Keywords
- Toenail fungus, Onychomycosis, Nail fungus, Toenail fungal infection, Tinea unguium, Dermatophytes, Foot dermatoses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jun 2008 (actual)
- First posted
- 7 Mar 2007 (estimated)
- Results
- Posted 20 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: terbinafineActive terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks |
| 2 | Placebo comparator | Drug: Placebovehicle (placebo) applied once daily for 48 weeks |
| 3 | Experimental | Drug: terbinafineActive terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks |
| 4 | Placebo comparator | Drug: Placebovehicle (placebo) applied once daily for 24 weeks |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male and females 12 - 75 years of age
- Fungal toenail infection of one or both of the large (great) toenails
- The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and non-dermatophyte] are not allowed)
Key exclusion criteria (7 listed)
- Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinifine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
- Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
- No administration of systemic antifungal medications within 6 months prior to screening visit
- No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
- No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
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 |
|---|---|---|
| terbinafineAlso: LamisilActive terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks | Drug | 1 |
| Placebovehicle (placebo) applied once daily for 48 weeks | Drug | 2 |
| terbinafineAlso: LamisilActive terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks | Drug | 3 |
| Placebovehicle (placebo) applied once daily for 24 weeks | Drug | 4 |
Primary outcome
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.
Time frame: 52 weeks
Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes. and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as "Yes" if: * Mycological cure (negative KOH and negative culture for dermatophytes) and * No residual involvement of the target toenail "No" if otherwise
3 secondary outcomes
Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.
Time frame: 52 weeks
Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.
Time frame: 52 weeks
Number of Participants Assessed With Adverse Events and Serious Adverse Events
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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
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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing terbinafine in people with Onychomycosis, run by Novartis Pharmaceuticals at 22 sites in 3 countries.
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 3 inclusion and 7 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 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada, Iceland. 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?
Yes. Results are posted in the registry (first posted 20 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. (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 3 May 2012.