OnycomycosisNCT01929187
A Randomized Study to Evaluate the Efficacy of Herbal Ingredients Combined With a Carrier System (Phytonail) Compared With Amorolfine 5% Nail Lacquer (Loceryl) in the Treatment of Toenail Onychomycosis
A study testing Phytonail and Loceryl in people with Onycomycosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background: Onychomycosis, the most common nail disorder, is a superficial fungal infection affecting toenails more than fingernails. Onychomycosis can cause pain and discomfort and has the potential to be a source of morbidity. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Onycomycosis
- What is being tested?
- Phytonail and Loceryl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2013to Jul 2014
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must meet ALL the criteria listed below both at Screening and Baseline (Day 1)
- Subjects must be aged 20 to 65 years at Screening, and can be either sex.
- Subjects must have onychomycosis, that (a) involves at least one great toenail (if two great toenails are infected, the one with greater involvement will be selected as target nail), and (b) has been mycologically confirmed at Screening Phase (positive potassium hydroxide (KOH) preparation and culture positive for dermatophytes, Candida spp., or molds).
- Subjects must have the target great toenail capable of growing.
- Subjects must be able to apply the study drugs to their toenails.
- Subjects must be willing to sign the informed consent form and be able to adhere to dose and visit schedules during the study
- Subjects must agree to use no other products including nail polish applied to the toenails during the study.
Who cannot join
- The subject will not be selected for the study if ANY of the criteria listed below are met at Screening and/or Baseline (Day 1)
- Subjects with a structural deformity of the target great toenail, including but not limited to genetic nail disorders, onychogryphosis, traumatic nail dystrophy, and/or any other abnormalities that in the investigator's judgment may interfere with efficacy assessments.
- Subjects with a current or past history of psoriasis and /or lichen planus.
- Subjects with a history of treatment failure (defined as no recognized increase in clean nail growth) after completion of ≧3 months of any oral antifungals.
- Subjects have controlled diabetes with HbA1C≧8%.
- Subjects with significant peripheral vascular disease or peripheral circulatory impairment, as evidenced by absence of dorsalis pedis or posterior tibial pulses.
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- Subject with a history of immunosuppression or presence of a serious concurrent medical condition that might adversely affect the evaluation of treatment response.
- Subjects with chronic tinea pedis (eg, moccasin type) that in the investigator's judgment would require systemic treatment.
- Subjects who have received any treatment listed below more recently than the indicated washout period or who must continue to receive such treatments Systemic antifungal treatments (24 weeks prior to Screening) Topical antifungal agents applied to the toenails, excluding antifungal agents for the treatment of tinea pedis (4 weeks prior to Screening) Investigational drugs (4 weeks prior to Screening) Oral or intramuscular corticosteroid or immunosuppressive agents (2 weeks prior to Day 1) Topical antifungal agents for the treatment of tinea pedis (prior to Day 1) Topical anti-inflammatory, topical corticosteroids, and topical immunosuppressive agents applied to the feet (2 weeks prior to Day 1)
- Subject with a history of hypersensitivity to morpholine antifungal agents or essential herbal oil;
- Women who are breast-feeding, pregnant, or intended to become pregnant; and
- Subjects who are unable to comply with the treatment regimen.
- Subjects who are participating in any other clinical study.
- Subjects who are part of the staff personnel directly involved with the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chiu-Nun Chen, +886+2-23562141, derm@ntuh.gov.tw
Jin-Bon Hong, MD
About this study
Background: Onychomycosis, the most common nail disorder, is a superficial fungal infection affecting toenails more than fingernails. Onychomycosis can cause pain and discomfort and has the potential to be a source of morbidity. Although oral antifungal agents achieve a better complete cure rate for onychomycosis, many patients are worried about the side effects and unwilling to take oral medications. Phytonail is a mixture of herbal active ingredients including tea tree oil, lavender oil and Australian blue cypress oil with BioEqual carrier system. A preliminary trial has shown a 100% KOH negative rate in 32 nails after 12 weeks of Phytonail therapy. Amorolfine 5% nail lacquer (Loceryl) is a broad-spectrum morpholine antifungal demonstrated 60-75% mycological cure rate in several randomized controlled trials for the treatment of toenail onychomycosis.
Objective: To evaluate the efficacy and safety of Phytonail relative to amorolfine 5% nail lacquer in the treatment of toenail onychomycosis.
Methods: This is a randomized, parallel-group, open-labeled study in adult subjects with toenail onychomycosis. In this study, 60 eligible patients will be randomized in a 1: 1 ratio to one of the two treatment groups: Phytonail or amorolfine 5% nail lacquer. Before randomization, patients are to have onychomycosis in at least one great toenail with positive KOH examination and positive fungal culture. During the treatment phase, Phytonail will be applied twice daily and amorolfine 5% nail lacquer once weekly for 16 weeks to all affected toenails. Physician's assessments and photographic analyses will be carried out at baseline, Week 4, 8, 16, and 24. Mycological evaluation including KOH examination will be performed at baseline, Week 4, 8, and 16. Fungal culture will be performed at baseline and for KOH negative patients.
Read the detailed description
Subjects aged 20-65 years with toenail onychomychosis involved at least one great toenail will be recruited in the study. Approximately 200 subjects will be screened, in order to randomize 72 eligible subjects. Allowing for approximately 20% drop-outs, it is estimated that for completing 60 eligible subjects, approximately 72 subjects would be enrolled. Subjects must meet all the inclusion criteria and none of the exclusion criteria to receive treatment assignment.
Procedures:
Explain study and obtain written informed consent: Screening Review inclusion/exclusion criteria including prior and concomitant medications: Screening and Baseline (Day 1) Demographics: Screening Medical history (including prior onychomycosis): Screening Personal and family history as well as history of any prior treatment for onychomycosis and any symptoms attributed to onychomycosis Physical examination: Screening Selection of target great toenail: Screening Proper nail trimming of target great toenail (as needed): all visits The subject's target great toenail will be properly trimmed as needed by the investigator or a qualified designee. Proper nail trimming is defined as cutting the nail plate to within 1 mm of the hyponychium or distal groove. In case of onycholysis the nail is to be trimmed not to the proximal limit of the onycholysis.
Percentage of nail involvement of the target great toenail based on signs of onychomycosis: all visits The percentage of involvement of the target great toenail will be determined by the investigator's visual estimate of the extent of the total nail area that shows signs of onychomycosis after proper trimming the nail.
Assessment of other toenails: all visits (except screening) At baseline (Day 1) and all subsequent visits, the investigator will identify all other toenails (excluding the target great toenail) with signs of onychomycosis and determine the total number of toenails that are completely clear (0% involvement) or almost clear (<10% involvement).
Marking the target great toenail: all visits The investigator will ink the distal groove, the 2-mm notch (except at Screening, when the notch will not have been made yet), and the healthy/involved limit of the target toenail with a supplied indelible marking pen. These markings on the target great toenail will be used to determine the CN, and will be used for the calculation of CNG and LNG. The initial photo of the unmarked nail must be taken before any marking is made.
Two-millimeter notch for the target great toenail: Baseline (Day 1) At the Baseline (Day 1) visit, the investigator will make a superficial notch in the nail plate, approximately 2 mm distal from the proximal nail fold. The investigator will ink the notch with a marking pen at this and each subsequent visit. If, as the nail grows, the investigator feels that the original notch may be clipped off at the next visit, a new nail notch approximately 2 mm from the proximal nail fold will be made.
KOH examination of the target great toenail: Screening, Week 4, 8, and 16. Fungal culture of the target great toenail: Screening, at Week 4, 8, and 16 only for KOH negative patients Digital photography: Baseline (Day 1); Week 4, 8, 16, and 24; early termination (if applicable)
Digital photographs will be analyzed for the following measurements:
Clear nail (CN) of the target great toenail: CN is defined as the distance (mm) between the PNF and the most proximal limit of the disease (as marked by the investigator).
Clear nail growth (CNG) of the target great toenail: The CNG is a calculation and is defined as the difference (mm) between the CN at a given visit and the CN at Baseline (Day 1). For example, if the baseline CN is 2 mm and the Week 12 CN is 5 mm, the nail will have 3 mm of new clear nail growth.
Linear nail growth (LNG) of the target great toenail: The LNG represents the growth of nail plate (normal and mycotic) over a period of time. LNG is defined as the distance at any given time point from the PNF to the nail notch, minus the distance of the notch from the PNF at Baseline (2 mm). For example, if at a post-Baseline visit the length from the proximal nail fold to the inked notch becomes 6 mm, then the nail will have growth 4 mm (6 mm- 2 mm= 4 mm).
Randomization: Baseline (Day 1) Subject dosing diary dispensing: Baseline (Day 1) through Week 8 Subject dosing diary collection: Week 4 through Week 16, and early termination Study drug dispensing: Baseline (Day 1) through Week 8 Study drug self-administration: Baseline (Day 1) through Week 16 Study drug collection: Week 4 through Week 16, and early termination Prior and concomitant drugs: All visits Record adverse events: All visits (except screening)
- Conditions
- Onycomycosis
- Being tested
- Phytonail, Loceryl
- Keywords
- Onychomycosis, BioEqual carrier system, amorolfine.
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhytonailDrug
Also called herbal ingredients combined with a carrier system (Phytonail)
LocerylDrug
Also called amorolfine 5% nail lacquer (Loceryl)
| Study group | Role | What they receive |
|---|---|---|
| Phytonail | Active comparator | Phytonail is a mixture of herbal active ingredients including tea tree oil, lavender oil and Australian blue cypress (ABC) oil with BioEqual carrier system. Receives: Drug: Phytonail |
| amorolfine 5% nail lacquer | Active comparator | 5% amorolfine Receives: Drug: Loceryl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycological cure
The primary efficacy endpoint of the study is the mycological cure rate of the target great toenail at Week 16. Mycological cure is defined as both negative KOH and negative fungal culture.
Measured: At week 16
Secondary outcomes (3)
The treatment success rate of the target toenail
Treatment success is defined as both almost clear nail (<10% nail involvement) after proper trimming, as determined by the investigator, and negative KOH and negative fungal culture.
Measured: At Week16 and Week 24.
The complete cure rate of the target toenail
Complete cure is defined as both completely clear nail (0% nail involvement) after proper trimming, as determined by the investigator, and negative KOH and negative fungal culture.
Measured: At Week 16 and Week 24
The CNG (clear nail growth) of the target great toenail
For other toenail excluding the target toenail, the proportion of nails that are completely clear (0% nail involvement) or almost clear (<10% nail involvement) at Baseline, Week 16 and Week 24.
Measured: Week 16 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnycomycosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Bon Hong, MD, Principal investigator, Department of Dermatology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929187
- Sponsor's protocol ID
- 201207030MSA
- Status last verified
- Jul 2013
- First submitted
- 22 Aug 2013
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Efficacy of Herbal Ingredients Combined With a Carrier System (Phytonail) Compared With Amorolfine 5% Nail Lacquer (Loceryl) in the Treatment of Toenail Onychomycosis
- ClinicalTrials.gov ID
- NCT01929187
- Acronym / sponsor ID
- 201207030MSA
- Conditions
- Onycomycosis
- Keywords
- Onychomycosis, BioEqual carrier system, amorolfine.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 27 Aug 2013 (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.
Background: Onychomycosis, the most common nail disorder, is a superficial fungal infection affecting toenails more than fingernails. Onychomycosis can cause pain and discomfort and has the potential to be a source of morbidity. Although oral antifungal agents achieve a better complete cure rate for onychomycosis, many patients are worried about the side effects and unwilling to take oral medications. Phytonail is a mixture of herbal active ingredients including tea tree oil, lavender oil and Australian blue cypress oil with BioEqual carrier system. A preliminary trial has shown a 100% KOH negative rate in 32 nails after 12 weeks of Phytonail therapy. Amorolfine 5% nail lacquer (Loceryl) is a broad-spectrum morpholine antifungal demonstrated 60-75% mycological cure rate in several randomized controlled trials for the treatment of toenail onychomycosis.
Objective: To evaluate the efficacy and safety of Phytonail relative to amorolfine 5% nail lacquer in the treatment of toenail onychomycosis.
Methods: This is a randomized, parallel-group, open-labeled study in adult subjects with toenail onychomycosis. In this study, 60 eligible patients will be randomized in a 1: 1 ratio to one of the two treatment groups: Phytonail or amorolfine 5% nail lacquer. Before randomization, patients are to have onychomycosis in at least one great toenail with positive KOH examination and positive fungal culture. During the treatment phase, Phytonail will be applied twice daily and amorolfine 5% nail lacquer once weekly for 16 weeks to all affected toenails. Physician's assessments and photographic analyses will be carried out at baseline, Week 4, 8, 16, and 24. Mycological evaluation including KOH examination will be performed at baseline, Week 4, 8, and 16. Fungal culture will be performed at baseline and for KOH negative patients.
Detailed description
Subjects aged 20-65 years with toenail onychomychosis involved at least one great toenail will be recruited in the study. Approximately 200 subjects will be screened, in order to randomize 72 eligible subjects. Allowing for approximately 20% drop-outs, it is estimated that for completing 60 eligible subjects, approximately 72 subjects would be enrolled. Subjects must meet all the inclusion criteria and none of the exclusion criteria to receive treatment assignment.
Procedures:
Explain study and obtain written informed consent: Screening Review inclusion/exclusion criteria including prior and concomitant medications: Screening and Baseline (Day 1) Demographics: Screening Medical history (including prior onychomycosis): Screening Personal and family history as well as history of any prior treatment for onychomycosis and any symptoms attributed to onychomycosis Physical examination: Screening Selection of target great toenail: Screening Proper nail trimming of target great toenail (as needed): all visits The subject's target great toenail will be properly trimmed as needed by the investigator or a qualified designee. Proper nail trimming is defined as cutting the nail plate to within 1 mm of the hyponychium or distal groove. In case of onycholysis the nail is to be trimmed not to the proximal limit of the onycholysis.
Percentage of nail involvement of the target great toenail based on signs of onychomycosis: all visits The percentage of involvement of the target great toenail will be determined by the investigator's visual estimate of the extent of the total nail area that shows signs of onychomycosis after proper trimming the nail.
Assessment of other toenails: all visits (except screening) At baseline (Day 1) and all subsequent visits, the investigator will identify all other toenails (excluding the target great toenail) with signs of onychomycosis and determine the total number of toenails that are completely clear (0% involvement) or almost clear (<10% involvement).
Marking the target great toenail: all visits The investigator will ink the distal groove, the 2-mm notch (except at Screening, when the notch will not have been made yet), and the healthy/involved limit of the target toenail with a supplied indelible marking pen. These markings on the target great toenail will be used to determine the CN, and will be used for the calculation of CNG and LNG. The initial photo of the unmarked nail must be taken before any marking is made.
Two-millimeter notch for the target great toenail: Baseline (Day 1) At the Baseline (Day 1) visit, the investigator will make a superficial notch in the nail plate, approximately 2 mm distal from the proximal nail fold. The investigator will ink the notch with a marking pen at this and each subsequent visit. If, as the nail grows, the investigator feels that the original notch may be clipped off at the next visit, a new nail notch approximately 2 mm from the proximal nail fold will be made.
KOH examination of the target great toenail: Screening, Week 4, 8, and 16. Fungal culture of the target great toenail: Screening, at Week 4, 8, and 16 only for KOH negative patients Digital photography: Baseline (Day 1); Week 4, 8, 16, and 24; early termination (if applicable)
Digital photographs will be analyzed for the following measurements:
Clear nail (CN) of the target great toenail: CN is defined as the distance (mm) between the PNF and the most proximal limit of the disease (as marked by the investigator).
Clear nail growth (CNG) of the target great toenail: The CNG is a calculation and is defined as the difference (mm) between the CN at a given visit and the CN at Baseline (Day 1). For example, if the baseline CN is 2 mm and the Week 12 CN is 5 mm, the nail will have 3 mm of new clear nail growth.
Linear nail growth (LNG) of the target great toenail: The LNG represents the growth of nail plate (normal and mycotic) over a period of time. LNG is defined as the distance at any given time point from the PNF to the nail notch, minus the distance of the notch from the PNF at Baseline (2 mm). For example, if at a post-Baseline visit the length from the proximal nail fold to the inked notch becomes 6 mm, then the nail will have growth 4 mm (6 mm- 2 mm= 4 mm).
Randomization: Baseline (Day 1) Subject dosing diary dispensing: Baseline (Day 1) through Week 8 Subject dosing diary collection: Week 4 through Week 16, and early termination Study drug dispensing: Baseline (Day 1) through Week 8 Study drug self-administration: Baseline (Day 1) through Week 16 Study drug collection: Week 4 through Week 16, and early termination Prior and concomitant drugs: All visits Record adverse events: All visits (except screening)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phytonail | Active comparator | Drug: PhytonailPhytonail is a mixture of herbal active ingredients including tea tree oil, lavender oil and Australian blue cypress (ABC) oil with BioEqual carrier system. |
| amorolfine 5% nail lacquer | Active comparator | Drug: Loceryl5% amorolfine |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject must meet ALL the criteria listed below both at Screening and Baseline (Day 1)
- Subjects must be aged 20 to 65 years at Screening, and can be either sex.
- Subjects must have onychomycosis, that (a) involves at least one great toenail (if two great toenails are infected, the one with greater involvement will be selected as target nail), and (b) has been mycologically confirmed at Screening Phase (positive potassium hydroxide (KOH) preparation and culture positive for dermatophytes, Candida spp., or molds).
- Subjects must have the target great toenail capable of growing.
- Subjects must be able to apply the study drugs to their toenails.
Key exclusion criteria (14 listed)
- The subject will not be selected for the study if ANY of the criteria listed below are met at Screening and/or Baseline (Day 1)
- Subjects with a structural deformity of the target great toenail, including but not limited to genetic nail disorders, onychogryphosis, traumatic nail dystrophy, and/or any other abnormalities that in the investigator's judgment may interfere with efficacy assessments.
- Subjects with a current or past history of psoriasis and /or lichen planus.
- Subjects with a history of treatment failure (defined as no recognized increase in clean nail growth) after completion of ≧3 months of any oral antifungals.
- Subjects have controlled diabetes with HbA1C≧8%.
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 |
|---|---|---|
| PhytonailAlso: herbal ingredients combined with a carrier system (Phytonail) | Drug | Phytonail |
| LocerylAlso: amorolfine 5% nail lacquer (Loceryl) | Drug | amorolfine 5% nail lacquer |
Primary outcome
Mycological cure
Time frame: At week 16
The primary efficacy endpoint of the study is the mycological cure rate of the target great toenail at Week 16. Mycological cure is defined as both negative KOH and negative fungal culture.
3 secondary outcomes
The treatment success rate of the target toenail
Time frame: At Week16 and Week 24.
The complete cure rate of the target toenail
Time frame: At Week 16 and Week 24
The CNG (clear nail growth) of the target great toenail
Time frame: Week 16 and Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
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.
Jin-Bon Hong, MD principal investigator
Department of Dermatology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phytonail and Loceryl in people with Onycomycosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 27 Aug 2013. 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shiu-lan Wang, Master (+886+975212275, belle896106@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mycological cure (time frame: At week 16). 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 27 Aug 2013.