OnychomycosisPhase 3NCT00459537
Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis
A Phase 3 study testing terbinafine hydrogen chloride and amorolfine nail lacquer in people with Onychomycosis, run by Novartis at 10 sites in 10 countries.
Trial summary
This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks. 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 hydrogen chloride and amorolfine nail lacquer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,029 participants
- Where
- 10 sitesin 10 countries
- Study dates
- Mar 2007to Jan 2009
- 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)
- The target toenail area must have at least 25% to no more than 75% disease involvement without spikes.
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 terbinafine 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
- Patients with the target toenail involving the matrix (lunula) or having less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
- Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
Show all 9Show fewer
- 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
10 sites in 10 countries.
10 sites in 10 countries
About this study
Official title: A Randomized, Open-label, Active-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride (HCl) Formulation Versus 5% Amorolfine Nail Lacquer for 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis
This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.
- Conditions
- Onychomycosis
- Being tested
- terbinafine hydrogen chloride, amorolfine nail lacquer
- 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.
terbinafine hydrogen chlorideDrug
Also called Lamisil
10 % terbinafine hydrogen chloride (HCL)
amorolfine nail lacquerDrug
5 % amorolfine nail lacquer
| Study group | Role | What they receive |
|---|---|---|
| Terbinafine | Experimental | 10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry. Receives: Drug: terbinafine hydrogen chloride |
| Amorolfine | Active comparator | 5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails. Receives: Drug: amorolfine nail lacquer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Measured: Week 52
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Measured: Week 52
Secondary outcomes (3)
Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.
Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.
Measured: Week 52
Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks
Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes
Measured: Week 52
Safety and Tolerability Assessed by the Number of Participants With Adverse Events
Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE or SAE and death. Additional details can be found in the Adverse Event Section.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionJan 2009
- Study completionJan 2009
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.
- 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
- None (open label)
- Enrolment
- 1,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459537
- Sponsor's protocol ID
- CSFO327N2303
- Status last verified
- May 2011
- First submitted
- 10 Apr 2007
- Last updated
- 6 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Active-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride (HCl) Formulation Versus 5% Amorolfine Nail Lacquer for 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis
- ClinicalTrials.gov ID
- NCT00459537
- Acronym / sponsor ID
- CSFO327N2303
- 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
- 1,029 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 12 Apr 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 will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terbinafine | Experimental | Drug: terbinafine hydrogen chloride10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry. |
| Amorolfine | Active comparator | Drug: amorolfine nail lacquer5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 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)
- The target toenail area must have at least 25% to no more than 75% disease involvement without spikes.
Key exclusion criteria (9 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 terbinafine 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
- Patients with the target toenail involving the matrix (lunula) or having less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
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 |
|---|---|---|
| terbinafine hydrogen chlorideAlso: Lamisil10 % terbinafine hydrogen chloride (HCL) | Drug | Terbinafine |
| amorolfine nail lacquer5 % amorolfine nail lacquer | Drug | Amorolfine |
Primary outcome
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks
Time frame: Week 52
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.
Time frame: Week 52
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
3 secondary outcomes
Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.
Time frame: Week 52
Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks
Time frame: Week 52
Safety and Tolerability Assessed by the Number of Participants With Adverse Events
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Onychomycosis
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In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
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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.
Novartis study director
Novartis
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing terbinafine hydrogen chloride and amorolfine nail lacquer in people with Onychomycosis, run by Novartis at 10 sites in 10 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 4 inclusion and 9 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 6 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Finland, France, Germany, Hungary, Iceland and 5 more countries. 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 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?
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks (time frame: Week 52). The study lists 2 primary outcomes in all. 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 6 May 2011.