OnychomycosisPhase 3NCT02547701
Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population
A Phase 3 study testing P-3058 in people with Onychomycosis, run by Polichem S.A. at 5 sites in 5 countries.
Trial summary
Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the appropriate treatment schedule. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- P-3058
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Aug 2014to Sep 2017
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 2 to 17 years
- Males and females
- Clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis.
- Positive mycroscopy examination from the target nail at screening.
- Positive culture for dermatophyte from the target nail at screening.
Who cannot join
- Patients with onychomycosis caused by yeasts or non-dermatophytes mould.
- Patients with nail psoriasis.
- Patients with nail changes due to eczema, lichen planus or alopecia areata.
- Patients with one-hand two-foot syndrome.
- Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it.
- Use of systemic antifungal drugs in the 6 months prior to screening visit.
- Use of topical nail antifungal drugs in the four weeks prior to screening visit.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Multicentre, Open Label Study to Assess the Tolerability of P-3058 Nail Solution in Paediatric Patients Affected by Mild-to-moderate Onychomycosis
Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the appropriate treatment schedule.
- Conditions
- Onychomycosis
- Being tested
- P-3058
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-3058Drug
| Study group | Role | What they receive |
|---|---|---|
| P-3058 | Experimental | Not described Receives: Drug: P-3058 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tolerability
Local tolerability at all treated nails by means of the Severity Score for Skin Irritation
Measured: from week 4 up to maximum week 48 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startAug 2014
- Primary completionSep 2017
- Study completionSep 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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 SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547701
- Sponsor's protocol ID
- PM Ped-004
- Other IDs
- 2013-005595-17
- Status last verified
- Mar 2018
- First submitted
- 8 Sep 2015
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Open Label Study to Assess the Tolerability of P-3058 Nail Solution in Paediatric Patients Affected by Mild-to-moderate Onychomycosis
- ClinicalTrials.gov ID
- NCT02547701
- Acronym / sponsor ID
- PM Ped-004
- Conditions
- Onychomycosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Polichem S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 11 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.
Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the appropriate treatment schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P-3058 | Experimental | Drug: P-3058 |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age between 2 to 17 years
- Males and females
- Clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis.
- Positive mycroscopy examination from the target nail at screening.
- Positive culture for dermatophyte from the target nail at screening.
Key exclusion criteria (7 listed)
- Patients with onychomycosis caused by yeasts or non-dermatophytes mould.
- Patients with nail psoriasis.
- Patients with nail changes due to eczema, lichen planus or alopecia areata.
- Patients with one-hand two-foot syndrome.
- Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it.
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 | Drug | P-3058 |
Primary outcome
Local tolerability
Time frame: from week 4 up to maximum week 48 of treatment
Local tolerability at all treated nails by means of the Severity Score for Skin Irritation
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 8 Mar 2018.
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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
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing P-3058 in people with Onychomycosis, run by Polichem S.A. at 5 sites in 5 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 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 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Germany, Italy, Latvia, Spain. 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?
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?
Local tolerability (time frame: from week 4 up to maximum week 48 of treatment). 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 8 Mar 2018.