Onychomycosis of ToenailPhase 3NCT03094468
Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis
A Phase 3 study testing P-3058 (terbinafine hydrochloride 10%) in people with Onychomycosis of Toenail, run by Polichem S.A. at 26 sites in 2 countries.
Trial summary
The aim of this phase III study is to establish the efficacy and safety of P-3058 (terbinafine 10% nail solution) topically administered once weekly in patients with onychomycosis in comparison to the Vehicle in a double-blind fashion. The overall treatment period will be of 48 weeks. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- P-3058 (terbinafine hydrochloride 10%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 26 sitesin 2 countries
- Study dates
- May 2017to Dec 2019
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent before starting any study related procedures.
- Patients aged 12 and older of any race.
- Males or females.
- Outpatients.
- Clinically diagnosed mild-to-moderate distal lateral subungual onychomycosis (DLSO) of at least one great toenail (the "target nail") at the Screening visit (V1).
- Patients with onychomycosis involving ≥ 20% to ≤ 50% of the area of the target great toenail.
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- Patients with a positive KOH examination.
- Patients with positive culture for dermatophyte(s).
- Evidence of target great toenail growth reported by the patient defined as at least monthly nail clipping.
Who cannot join
- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Patients with history of allergic reactions to terbinafine or its excipients.
- Use of any investigational drug/device or participation in a previous clinical trial within four weeks prior to Screening visit (V1).
- Patients using nail polish or other nail cosmetic product on the concerned nails from at least 24 hours prior to Screening visit (V1) until the end of the study.
- Use of systemic antifungal drugs in the 24 weeks prior to Screening visit (V1) or non-responsive to systemic antifungal therapy for onychomycosis.
- Nail application of topical antifungal drugs or device in the 4 weeks prior to Screening visit (V1).
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- Presence of any nail infections other than dermatophyte.
- Presence of onychodystrophy that could interfere with clinical assessments.
- Presence of "yellow spikes" on the target nail.
- Presence of dermatophytoma on the target nail.
- Presence of nail thickness exceeding 2 mm.
- Patients with proximal subungual involvement (marker of immunosuppressed patient).
- Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate).
- Patients with nail abnormalities due to conditions like psoriasis, lichen planus, immune dysfunction, collagen-vascular diseases, peripheral vascular disease.
- Patients with life expectancy less than 2 years.
- Chemotherapy, immunosuppressive therapy in the 12 weeks prior to Screening visit (V1).
- Systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to Screening visit (V1).
- HIV infection or any other immunodeficiency.
- Alcohol or substance abuse.
- Patients/parents (or legal guardian) unable to understand the procedures and purposes of the study.
- Any other condition that, in the opinion of the Investigator, would prevent the subject from effectively participating in the study, place the subject at risk or effect the assessment of efficacy and safety of the study medication.
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States21 sites
Polichem Investigation Site no 10
Austin, Texas, 78731
Polichem Investigation Site no 44
Cincinnati, Ohio, 45249
Polichem Investigation Site no 11
Dallas, Texas, 75234
Polichem Investigation Site no 43
Dallas, Texas, 75246
Polichem Investigation Site no 6
Fort Worth, Texas, 76107
Polichem Investigation Site no 2
Hialeah, Florida, 33012
Polichem Investigation Site no 12
Houston, Texas, 77055
Polichem Investigation Site no 4
Houston, Texas, 77081
Polichem Investigation Site no 23
Jacksonville, Florida, 32204
Polichem Investigation Site no 52
Louisville, Kentucky, 40202
Polichem Investigation Site no 22
Miami, Florida, 33176
Polichem Investigation site no 1
New York, New York, 10025
Polichem Investigation Site no 40
Norman, Oklahoma, 71071
Polichem Investigation Site no 45
North Hollywood, California, 91606
Polichem Investigation Site no 5
Oceanside, California, 92056
Polichem Investigation Site no 14
Oklahoma City, Oklahoma, 73103
Polichem Investigation Site no 42
Pflugerville, Texas, 78660
Polichem Investigation Site no 41
Portsmouth, New Hampshire, 03801
Polichem Investigation Site no 53
San Antonio, Texas, 78229
Polichem Investigation Site no 54
San Antonio, Texas, 78249
Polichem Investigation Site no 39
San Diego, California, 92123
Canada5 sites
Polichem Investigation site no 3
Calgary, Alberta, T2G 1B1
Polichem Investigation Site no 8
Edmonton, Alberta, T5K 1X3
Polichem Investigation Site no 13
Mississauga, Ontario, L5H 1G9
Polichem Investigation Site no 9
Richmond Hill, Ontario, L4C 9M7
Polichem Investigation Site no 7
Toronto, Ontario, M9W 4L6
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel, Vehicle-controlled Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Onychomycosis
The aim of this phase III study is to establish the efficacy and safety of P-3058 (terbinafine 10% nail solution) topically administered once weekly in patients with onychomycosis in comparison to the Vehicle in a double-blind fashion. The overall treatment period will be of 48 weeks.
Read the detailed description
The study will consist of a screening phase, a treatment phase of 48 weeks and a 12-week follow-up. Patients affected by mild to-moderate distal lateral subungual onychomycosis (DLSO) on a target great toenail will be included in the study. Clinical as well as mycology assessments will be performed throughout the whole study. Safety will be monitored by recording any adverse event and evaluating local tolerability.
- Conditions
- Onychomycosis of Toenail
- Being tested
- P-3058 (terbinafine hydrochloride 10%), Vehicle of P-3058
- Keywords
- terbinafine nail solution, nail fungal infection, topical antifungal drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-3058 (terbinafine hydrochloride 10%)Drug
Patients will apply the P-3058 nail solution once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.
Vehicle of P-3058Drug
Patients will apply the Vehicle of P-3058 once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| P-3058 | Experimental | Not described Receives: Drug: P-3058 (terbinafine hydrochloride 10%) |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle of P-3058 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete cure at Week 60
Defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement (nail totally clear) of the target nail.
Measured: Baseline - Week 60
Secondary outcomes (2)
Responder rate at Week 60
Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes and ≤ 10% residual involvement of the target toenail)
Measured: Baseline - Week 60
Mycological cure rate at Week 60
Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes of the target nail.
Measured: Baseline - Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study startMay 2017 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Project development priorities changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onychomycosis of ToenailStudies 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
- Model description
- Vehicle-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polichem S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Almirall, S.A.
- Responsible party
- Sponsor
- Investigators
- Maurizio Caserini, MD, Study director, Polichem SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094468
- Sponsor's protocol ID
- PM1328
- Status last verified
- Jan 2018
- First submitted
- 21 Mar 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel, Vehicle-controlled Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Onychomycosis
- ClinicalTrials.gov ID
- NCT03094468
- Acronym / sponsor ID
- PM1328
- Conditions
- Onychomycosis of Toenail
- Keywords
- terbinafine nail solution, nail fungal infection, topical antifungal drug
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project development priorities changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Polichem S.A.Industry (pharma, biotech, devices)
- Collaborators
- Almirall, S.A.
- Study start
- May 2017 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Mar 2017 (actual)
- 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.
The aim of this phase III study is to establish the efficacy and safety of P-3058 (terbinafine 10% nail solution) topically administered once weekly in patients with onychomycosis in comparison to the Vehicle in a double-blind fashion. The overall treatment period will be of 48 weeks.
Detailed description
The study will consist of a screening phase, a treatment phase of 48 weeks and a 12-week follow-up. Patients affected by mild to-moderate distal lateral subungual onychomycosis (DLSO) on a target great toenail will be included in the study. Clinical as well as mycology assessments will be performed throughout the whole study. Safety will be monitored by recording any adverse event and evaluating local tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Vehicle-controlled
| Arm | Type | Receives |
|---|---|---|
| P-3058 | Experimental | Drug: P-3058 (terbinafine hydrochloride 10%) |
| Vehicle | Placebo comparator | Drug: Vehicle of P-3058 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent before starting any study related procedures.
- Patients aged 12 and older of any race.
- Males or females.
- Outpatients.
- Clinically diagnosed mild-to-moderate distal lateral subungual onychomycosis (DLSO) of at least one great toenail (the "target nail") at the Screening visit (V1).
Key exclusion criteria (21 listed)
- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Patients with history of allergic reactions to terbinafine or its excipients.
- Use of any investigational drug/device or participation in a previous clinical trial within four weeks prior to Screening visit (V1).
- Patients using nail polish or other nail cosmetic product on the concerned nails from at least 24 hours prior to Screening visit (V1) until the end of the study.
- Use of systemic antifungal drugs in the 24 weeks prior to Screening visit (V1) or non-responsive to systemic antifungal therapy for onychomycosis.
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 |
|---|---|---|
| P-3058 (terbinafine hydrochloride 10%)Patients will apply the P-3058 nail solution once weekly in a double blind fashion. The overall treatment phase is of 48 weeks. | Drug | P-3058 |
| Vehicle of P-3058Patients will apply the Vehicle of P-3058 once weekly in a double blind fashion. The overall treatment phase is of 48 weeks. | Drug | Vehicle |
Primary outcome
Rate of complete cure at Week 60
Time frame: Baseline - Week 60
Defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement (nail totally clear) of the target nail.
2 secondary outcomes
Responder rate at Week 60
Time frame: Baseline - Week 60
Mycological cure rate at Week 60
Time frame: Baseline - Week 60
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Maurizio Caserini, MD study director
Polichem SA
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing P-3058 (terbinafine hydrochloride 10%) in people with Onychomycosis of Toenail, run by Polichem S.A. at 26 sites in 2 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 9 inclusion and 21 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: withdrawn, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of complete cure at Week 60 (time frame: Baseline - Week 60). 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 10 Jan 2018.