OnychomycosisPhase 1/2NCT01044381
Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis
A Phase 1/2 study testing Luliconazole Solution, 10% in people with Onychomycosis, run by Topica Pharmaceuticals at 1 site in United States.
Trial summary
To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting in adults with distal subungual onychomycosis of the toenails. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Luliconazole Solution, 10%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to May 2011
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years
- Distal Subungual Onychomycosis(DSO)on both great toenails with >=50%involvement of at least 1 great toenail
- At least 4 additional toenails with DSO
- Positive KOH and culture
- Normal renal and hepatic function
Who cannot join
- Subjects with hypersensitivity to imidazole compounds or any other ingredient
- Subjects unwilling to refrain from use of nail cosmetics until end of study
- Subjects with symptomatic tinea pedis
- Subjects with any history of cardiac disease of cardiac rhythm abnormalities
- Female subjects who are pregnant, nursing, or planning a pregnancy
- Subjects who have not undergone the specified washout period(s) for the following or requiring the concurrent use of: topical antifungal within 4 weeks; topical anti-inflammatory, corticosteroids, topical immunomodulators within 2 weeks; systemic corticosteroids within 2 weeks; systemic immunomodulators within 4 weeks.
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- Subjects receiving systemic antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophytes within the previous 12 weeks or 5 half-lives of the drug, whichever is longer
- Subjects receiving any other treatment/therapy for the onychomycosis not previously mentioned (e.g., laser treatment) within 4 weeks
- Subjects with a history of significant internal disease or with a life threatening condition within the last 6 months
- Subjects with anatomic abnormalities of the toe(s) and or toenails
- Subject who have donated or lost a large volume of blood (~500 mL or more, during the previous 6 weeks
- Subjects with a recent history of or currently known to abuse drugs or alcohol
- Subjects currently participating in another investigational medication or device study or have participated in a clinical trial within 30 days or five half-lives of the test medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2a, Open-Label Study Evaluating the Pharmacokinetics, Safety and Tolerability of Luliconazole Solution, 10% in Subjects With Moderate to Severe Distal Subungual Onychomycosis
To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting in adults with distal subungual onychomycosis of the toenails.
- Conditions
- Onychomycosis
- Being tested
- Luliconazole Solution, 10%
- Keywords
- Toenail, Fungal Infections, DSO
- Medical subject headings
- Onychomycosis, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luliconazole Solution, 10%Drug
28 days of daily application
| Study group | Role | What they receive |
|---|---|---|
| Luliconazole Solution, 10% | Experimental | Not described Receives: Drug: Luliconazole Solution, 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters (AUC, Cmax, Tmax, t1/2) will be measured at days 1 (Baseline), 9, 15 and 29. Safety assessments include monitoring of adverse events, local site tolerability, ECG monitoring, and changes in laboratory values and vital signs.
Measured: March 2011
Secondary outcomes (1)
Evaluation of linear toenail growth.
Measured: March 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2011
- Study completionMay 2011
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topica Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terry M Jones, M.D., Principal investigator, J&S Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044381
- Sponsor's protocol ID
- TP-0901-S
- Status last verified
- Nov 2014
- First submitted
- 4 Jan 2010
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Open-Label Study Evaluating the Pharmacokinetics, Safety and Tolerability of Luliconazole Solution, 10% in Subjects With Moderate to Severe Distal Subungual Onychomycosis
- ClinicalTrials.gov ID
- NCT01044381
- Acronym / sponsor ID
- TP-0901-S
- Conditions
- Onychomycosis
- Keywords
- Toenail, Fungal Infections, DSO
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Topica PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Jan 2010 (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.
To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting in adults with distal subungual onychomycosis of the toenails.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luliconazole Solution, 10% | Experimental | Drug: Luliconazole Solution, 10% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years
- Distal Subungual Onychomycosis(DSO)on both great toenails with >=50%involvement of at least 1 great toenail
- At least 4 additional toenails with DSO
- Positive KOH and culture
- Normal renal and hepatic function
Key exclusion criteria (13 listed)
- Subjects with hypersensitivity to imidazole compounds or any other ingredient
- Subjects unwilling to refrain from use of nail cosmetics until end of study
- Subjects with symptomatic tinea pedis
- Subjects with any history of cardiac disease of cardiac rhythm abnormalities
- Female subjects who are pregnant, nursing, or planning a pregnancy
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 |
|---|---|---|
| Luliconazole Solution, 10%28 days of daily application | Drug | Luliconazole Solution, 10% |
Primary outcome
PK parameters (AUC, Cmax, Tmax, t1/2) will be measured at days 1 (Baseline), 9, 15 and 29. Safety assessments include monitoring of adverse events, local site tolerability, ECG monitoring, and changes in laboratory values and vital signs.
Time frame: March 2011
1 secondary outcome
Evaluation of linear toenail growth.
Time frame: March 2011
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 Nov 2014.
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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.
Terry M Jones, M.D. principal investigator
J&S Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Luliconazole Solution, 10% in people with Onychomycosis, run by Topica Pharmaceuticals at 1 site in United States.
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 Nov 2014. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
PK parameters (AUC, Cmax, Tmax, t1/2) will be measured at days 1 (Baseline), 9, 15 and 29. Safety assessments include monitoring of adverse events, local site tolerability, ECG monitoring, and changes in laboratory values and vital signs. (time frame: March 2011). 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 Nov 2014.