OnychomycosisPhase 3NCT02549001
Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis
A Phase 3 study testing P-3058 10% and amorolfine 5% in people with Onychomycosis, run by Polichem S.A. at 13 sites in 13 countries.
Trial summary
The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Onychomycosis
- What is being tested?
- P-3058 10% and amorolfine 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 953 participants
- Where
- 13 sitesin 13 countries
- Study dates
- 20 Aug 2015to 17 Sep 2018
- 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
- Patients aged 12 years and older of any race.
- Males or females.
- Patients with onychomycosis involving ≥ 20% to ≤ 50% of target big toenail.
- Patients with a positive KOH examination and culture positive for dermatophyte
Who cannot join
- 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
- Patients with severe plantar or moccasin tinea pedis
- Patients with nail abnormalities due to other conditions
Show all 13Show fewer
- 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 with history of allergic reactions to terbinafine or its excipients.
- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
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 purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.
- Conditions
- Onychomycosis
- Being tested
- P-3058 10%, vehicle of P-3058 10%, amorolfine 5%
- Keywords
- Onychomycosis, Nail fungus
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-3058 10%Drug
vehicle of P-3058 10%Drug
amorolfine 5%Drug
Also called Loceryl®
| Study group | Role | What they receive |
|---|---|---|
| P-3058 10% | Experimental | P-3058 10% Receives: Drug: P-3058 10% |
| vehicle of P-3058 10% | Placebo comparator | vehicle of P-3058 10% Receives: Drug: vehicle of P-3058 10% |
| amorolfine 5% | Active comparator | Loceryl® Receives: Drug: amorolfine 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear.
Measured: Week 60
Secondary outcomes (4)
Responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes and ≤10% residual involvement of the target toenail.
Measured: Week 60
Negative culture rate for dermatophytes of the target nail.
Measured: Week 60
Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail.
Measured: Week 60
Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.
Measured: Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study start20 Aug 2015
- Primary completion17 Sep 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 953 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polichem S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurizio Caserini, MD, Study director, Polichem S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549001
- Sponsor's protocol ID
- PM1331
- Other IDs
- 2015-000561-31, 2015
- Status last verified
- Sep 2018
- First submitted
- 8 Sep 2015
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 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
- NCT02549001
- Acronym / sponsor ID
- PM1331
- Conditions
- Onychomycosis
- Keywords
- Onychomycosis, Nail fungus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 953 participants (actual)
- Lead sponsor
- Polichem S.A.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2015 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 14 Sep 2015 (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.
The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P-3058 10% | Experimental | Drug: P-3058 10%P-3058 10% |
| vehicle of P-3058 10% | Placebo comparator | Drug: vehicle of P-3058 10%vehicle of P-3058 10% |
| amorolfine 5% | Active comparator | Drug: amorolfine 5%Loceryl® |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- Patients aged 12 years and older of any race.
- Males or females.
- Patients with onychomycosis involving ≥ 20% to ≤ 50% of target big toenail.
- Patients with a positive KOH examination and culture positive for dermatophyte
Key exclusion criteria (13 listed)
- 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
- Patients with severe plantar or moccasin tinea pedis
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 10% | Drug | P-3058 10% |
| vehicle of P-3058 10% | Drug | vehicle of P-3058 10% |
| amorolfine 5%Also: Loceryl® | Drug | amorolfine 5% |
Primary outcome
Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear.
Time frame: Week 60
4 secondary outcomes
Responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes and ≤10% residual involvement of the target toenail.
Time frame: Week 60
Negative culture rate for dermatophytes of the target nail.
Time frame: Week 60
Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail.
Time frame: Week 60
Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.
Time frame: Week 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
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
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
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.
Maurizio Caserini, MD study director
Polichem S.A.
13 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing P-3058 10% and amorolfine 5% in people with Onychomycosis, run by Polichem S.A. at 13 sites in 13 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 5 inclusion and 13 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 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Belgium, Bulgaria, Czechia, Germany, Greece and 8 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear. (time frame: 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 26 Sep 2018.