OnychomycosisPhase 2NCT02644551
The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis
A Phase 2 study testing CELEXT07 and Penlac in people with Onychomycosis, run by 9305-9954 Quebec Inc at 1 site in Canada.
Trial summary
This will be an interventional safety and efficacy study of CELENT07 when used as a topical treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis
- What is being tested?
- CELEXT07 and Penlac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Sep 2018
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible to be included in the study only if they meet all of the following criteria:
- Age > 18.
- Clinically diagnosed onychomycosis of the target nail.
- Presence of mild to moderate onychomycosis, defined as 20-50% of the area of the target nail being clinically affected.
- Has a positive KOH examination from the target nail.
- Has a positive dermatophyte culture from the target nail.
- Written informed consent obtained.
- Subject agreed to follow the protocol.
Who cannot join
- Subjects will be excluded from the study if they meet any of the following criteria:
- Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug.
- Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis.
- Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit.
- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Inability to understand and comply with the instructions of the study
- Patients less than age 18
- Individuals with known allergy/hypersensitivity to Thuja occidentalis, Chelidonium majus, Eucalyptus citriodora, Tea tree or Thymus vulgaris.
Trial locations and contacts
1 site in 1 country.
Liza Lymberopoulos contact
Canada1 site, 1 recruiting
- Recruiting
Clinique podiatrique de Montréal
Montreal, Quebec, H1X 2B3
William Lee, 514 254-5000, drwlee@hotmail.com
About this study
Official title: The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis: a Phase 2, Randomized, Double-blind Study
This will be an interventional safety and efficacy study of CELENT07 when used as a topical treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. This is randomized, double-blind, parallel design, placebo and active controlled study in patients with mild to moderate toenail distal lateral subungual onychomycosis (DLSO) (n=120). Subjects will be randomized (1:1:1) to receive CELENXT07, placebo of CELENXT07 or PENLAC®, daily for 52 weeks. Efficacy assessments will include complete cure, mycologic cure and clinical efficacy and safety and tolerability.
- Conditions
- Onychomycosis
- Being tested
- CELEXT07, Penlac, vehicle solution
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELEXT07Drug
PenlacDrug
Also called topical Penlac nail lacquer
vehicle solutionOther
Also called placebo
| Study group | Role | What they receive |
|---|---|---|
| CELEXT07 | Experimental | suspension that is applied topically to the infected nail(s) daily. Receives: Drug: CELEXT07 |
| placebo | Placebo comparator | placebo is a suspension that simulates the physical properties of the experimental agent CELEXT07. It is applied topically to the infected nail(s) daily. Receives: Other: vehicle solution |
| Penlac | Active comparator | Is a standard of care for the condition and is applied topically to the infected nail(s) daily. Receives: Drug: Penlac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks
Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes.
and no residual involvement of the target toenail. The complete cure is a composite binary variable defined as "Yes" if:
- Mycological cure (negative KOH and negative culture for dermatophytes) and
- No residual involvement of the target toenail "No" if otherwise
Measured: week 52
Secondary outcomes (3)
Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 52 Weeks.
Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.Clinical effectiveness is a composite binary variable defined as "Yes" if
- Mycological cure (negative KOH and negative culture for dermatophytes) and ◦= 10% residual involvement of the target toenail "No" if otherwise
Measured: week 52
Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 52 Weeks.
Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.
Mycological cure is a composite binary variable defined as "Yes"if :
- Negative microscopy and
- Negative culture for dermatophytes "No" if otherwise.
Measured: week 52
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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 posted1 Jan 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2018 (estimated)
- Study completionSep 2018 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 9305-9954 Quebec Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Céline Devaux, MD, FRCPC, Principal investigator, 9305-9954 Quebec IncGuy Chamberland, M.Sc., Ph.D., Study director, 9305-9954 Quebec Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644551
- Sponsor's protocol ID
- CELEXT07-01
- Status last verified
- Apr 2017
- First submitted
- 29 Dec 2015
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis: a Phase 2, Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT02644551
- Acronym / sponsor ID
- CELEXT07-01
- Conditions
- Onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- 9305-9954 Quebec IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 1 Jan 2016 (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.
This will be an interventional safety and efficacy study of CELENT07 when used as a topical treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. This is randomized, double-blind, parallel design, placebo and active controlled study in patients with mild to moderate toenail distal lateral subungual onychomycosis (DLSO) (n=120). Subjects will be randomized (1:1:1) to receive CELENXT07, placebo of CELENXT07 or PENLAC®, daily for 52 weeks. Efficacy assessments will include complete cure, mycologic cure and clinical efficacy and safety and tolerability.
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 |
|---|---|---|
| CELEXT07 | Experimental | Drug: CELEXT07suspension that is applied topically to the infected nail(s) daily. |
| placebo | Placebo comparator | Other: vehicle solutionplacebo is a suspension that simulates the physical properties of the experimental agent CELEXT07. It is applied topically to the infected nail(s) daily. |
| Penlac | Active comparator | Drug: PenlacIs a standard of care for the condition and is applied topically to the infected nail(s) daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects are eligible to be included in the study only if they meet all of the following criteria:
- Age > 18.
- Clinically diagnosed onychomycosis of the target nail.
- Presence of mild to moderate onychomycosis, defined as 20-50% of the area of the target nail being clinically affected.
- Has a positive KOH examination from the target nail.
Key exclusion criteria (8 listed)
- Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug.
- Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis.
- Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit.
- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Inability to understand and comply with the instructions of the study
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 |
|---|---|---|
| CELEXT07 | Drug | CELEXT07 |
| PenlacAlso: topical Penlac nail lacquer | Drug | Penlac |
| vehicle solutionAlso: placebo | Other | placebo |
Primary outcome
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks
Time frame: week 52
Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes. and no residual involvement of the target toenail. The complete cure is a composite binary variable defined as "Yes" if: * Mycological cure (negative KOH and negative culture for dermatophytes) and * No residual involvement of the target toenail "No" if otherwise
3 secondary outcomes
Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 52 Weeks.
Time frame: week 52
Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 52 Weeks.
Time frame: week 52
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- 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.
Liza Lymberopoulos contact
Céline Devaux, MD, FRCPC principal investigator
9305-9954 Quebec Inc
Guy Chamberland, M.Sc., Ph.D. study director
9305-9954 Quebec Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CELEXT07 and Penlac in people with Onychomycosis, run by 9305-9954 Quebec Inc at 1 site in Canada.
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 8 inclusion and 8 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 26 Apr 2017. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Wil Lee, DPM, AACFAS (514-254-5000, drwlee@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks (time frame: week 52). 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 Apr 2017.