A Phase 4 interventional study of Luliconazole Cream 1% in Tinea Pedis and Tinea Cruris, sponsored by Bausch Health Americas, Inc.. Completed at 2 sites in 2 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Bausch Health Americas, Inc. (part of Bausch Health Companies Inc.) · Phase 4, Interventional, and Treatment
The objective of this study is to evaluate the pharmacokinetics of luliconazole cream 1%, as measured by circulating plasma levels of luliconazole, when maximal quantity of luliconazole cream 1% is applied to participants of 12 years to less than (\<) 18 years of age with moderate to severe inter-digital tinea pedis or tinea cruris.
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's enrollment of 30 is below the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →Bausch Health Americas, Inc. is the lead sponsor of 213 studies on the registry; 7 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
First submitted after Bausch Health Americas, Inc. became part of Bausch Health Companies Inc..
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas, including up to the ankles.
Drug: Luliconazole Cream 1%
Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas, including up to the groin, thighs, and abdomen.
Drug: Luliconazole Cream 1%
Luliconazole cream will be applied topically per schedule specified in the arms.
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole
Plasma concentration of luliconazole was determined using validated liquid chromatography-mass spectrometry (LC/MS) method.
Time frame: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Luliconazole
Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method.
Time frame: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole
Plasma concentration of luliconazole was determined using validated LC/MS method.
Time frame: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole
Plasma concentration of luliconazole was determined using validated LC/MS method.
Time frame: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole
Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method.
Time frame: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole
Plasma concentration of luliconazole was determined using validated LC/MS method.
Time frame: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
| Milestone | Tinea Pedis | Tinea Cruris |
|---|---|---|
| Started | 15 | 15 |
| Safety population | 15 | 15 |
| Pharmacokinetic pedis (pkp) population | 15 | 0 |
| Pharmacokinetic cruris (pkc) population | 0 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
Plasma concentration of luliconazole was determined using validated liquid chromatography-mass spectrometry (LC/MS) method.
| nanograms/milliliter (ng/mL) | Tinea Pedis |
|---|---|
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole | 3.27 ± 1.71 |
Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method.
| nanograms*hour/milliliter (ng*hr/mL) | Tinea Pedis |
|---|---|
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Luliconazole | 60.38 ± 37.92 |
Plasma concentration of luliconazole was determined using validated LC/MS method.
No measurements were reported for this outcome.
Plasma concentration of luliconazole was determined using validated LC/MS method.
| ng/mL | Tinea Cruris |
|---|---|
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole | 15.40 ± 13.62 |
Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method.
| ng*hr/mL | Tinea Cruris |
|---|---|
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole | 266.06 ± 236.07 |
Plasma concentration of luliconazole was determined using validated LC/MS method.
| hours | Tinea Cruris |
|---|---|
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole | 49.77 ± 22.74 |
Collected over Baseline (Day 1) up to Day 16. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tinea Pedis | — | 0/15 (0%) | 2/15 (13.3%) |
| Tinea Cruris | — | 0/15 (0%) | 1/15 (6.7%) |
| Event | Tinea Pedis | Tinea Cruris |
|---|---|---|
| DiarrheaGastrointestinal disorders | 1/15 | 0/15 |
| NasopharyngitisInfections and infestations | 0/15 | 1/15 |
| HeadacheNervous system disorders | 1/15 | 0/15 |
Safety population included all participants who were enrolled and received at least 1 application of study drug.
| Age, Continuous(years) | Tinea Pedis | Tinea Cruris | Total |
|---|---|---|---|
| Mean | 14.13 ± 2.17 | 15.27 ± 1.49 | 14.70 ± 1.91 |
| Sex: Female, Male(Participants) | Tinea Pedis | Tinea Cruris | Total |
|---|---|---|---|
| Female | 2 | 5 | 7 |
| Male | 13 | 10 | 23 |
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2015 to primary completion in Apr 2016, 4 months.
Results were first posted in Nov 2019, 3 years 7 months after primary completion. A results delay was requested in Dec 2017.
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Studies of the drug tested here: Luliconazole
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