A Phase 4 interventional study of Omeprazole 40 mg and Luliconazole Cream 1% in Tinea Pedis and Tinea Cruris, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Phase 4, Interventional, and Treatment
This is an open-label, maximal use study to evaluate whether luliconazole in plasma acts as an inhibitor of cytochrome P2C19 (CYP2C19) as measured by circulating levels of omeprazole before and after treatment with a maximum dose of luliconazole cream 1% in participants with moderate to severe tinea pedis and tinea cruris.
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's enrollment of 20 is below the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.
First submitted after Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 1 oral capsule of omeprazole 40 milligrams (mg) on Day 1 and Day 8. Participants will also receive luliconazole cream 1% to cover the entire affected surface areas and adjacent areas once daily in the morning on Day 2 (24 hours after initial omeprazole dosing) through Day 8.
Drug: Omeprazole 40 mg · Drug: Luliconazole Cream 1%
Oral capsule to be taken as per the instructions regarding proper dosing technique.
Topical cream to be applied as per the instructions regarding proper study drug application technique.
Also known as: LUZU Cream 1%
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1%
Circulating plasma levels of omeprazole were measured using validated liquid chromatography with tandem mass spectrometry detection (LS/MS-MS) methods. The range for omeprazole determination was 4.64-9.27 nanograms/milliliter (ng/mL). Serial blood sampling occurred in each enrolled participant up to 24 hours post treatment (Day 1) with omeprazole (before the start of luliconazole cream 1% treatment on Day 2).
Time frame: 15 minutes predose; 15, 30, 45, and 60 minutes postdose; and 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose of omeprazole on Day 1
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1%
Circulating plasma levels of omeprazole were measured using validated LS/MS-MS methods. The range for omeprazole determination was 4.64-9.27 ng/mL. Serial blood sampling occurred in each enrolled participant up to 24 hours post treatment (Day 8) with omeprazole (after using luliconazole cream 1% treatment for 1 week).
Time frame: 15 minutes predose; 15, 30, 45, and 60 minutes postdose; and 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose of omeprazole on Day 8
| Milestone | Luliconazole Cream 1% |
|---|---|
| Started | 20 |
| Received at least 1 dose of study drug | 20 |
| Completed | 18 |
| Not completed | 2 |
| Withdrew: Failed drug screen test | 1 |
| Withdrew: Adverse event | 1 |
Circulating plasma levels of omeprazole were measured using validated liquid chromatography with tandem mass spectrometry detection (LS/MS-MS) methods. The range for omeprazole determination was 4.64-9.27 nanograms/milliliter (ng/mL). Serial blood sampling occurred in each enrolled participant up to 24 hours post treatment (Day 1) with omeprazole (before the start of luliconazole cream 1% treatment on Day 2).
| ng/mL | Luliconazole Cream 1% |
|---|---|
| Predose | 0 ± 0 |
| 15 minutes postdose | 0 ± 0 |
| 30 minutes postdose | 23.67 ± 89.46 |
| 45 minutes postdose | 196.30 ± 301.31 |
| 1 hour postdose | 463.74 ± 546.51 |
| 1.5 hours postdose | 526.98 ± 499.60 |
| 2 hours postdose | 655.70 ± 520.31 |
| 2.5 hours postdose | 621.08 ± 464.55 |
| 3 hours postdose | 636.60 ± 508.53 |
| 4 hours postdose | 468.79 ± 355.49 |
| 6 hours postdose | 235.20 ± 214.29 |
| 8 hours postdose | 129.70 ± 129.08 |
| 10 hours postdose | 74.24 ± 84.54 |
| 24 hours postdose | 3.32 ± 6.18 |
Circulating plasma levels of omeprazole were measured using validated LS/MS-MS methods. The range for omeprazole determination was 4.64-9.27 ng/mL. Serial blood sampling occurred in each enrolled participant up to 24 hours post treatment (Day 8) with omeprazole (after using luliconazole cream 1% treatment for 1 week).
| ng/mL | Luliconazole Cream 1% |
|---|---|
| Predose | 0 ± 0 |
| 15 minutes postdose | 0 ± 0 |
| 30 minutes postdose | 18.11 ± 68.24 |
| 45 minutes postdose | 142.72 ± 298.29 |
| 1 hour postdose | 317.21 ± 401.97 |
| 1.5 hours postdose | 637.56 ± 509.09 |
| 2 hours postdose | 763.51 ± 607.80 |
| 2.5 hours postdose | 700.91 ± 423.74 |
| 3 hours postdose | 730.56 ± 349.10 |
| 4 hours postdose | 586.83 ± 309.83 |
| 6 hours postdose | 323.40 ± 219.50 |
| 8 hours postdose | 190.15 ± 154.82 |
| 10 hours postdose | 111.51 ± 102.30 |
| 24 hours postdose | 6.84 ± 10.01 |
Collected over Baseline up to Day 9. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Luliconazole Cream 1% | — | 0/20 (0%) | 4/20 (20%) |
| Event | Luliconazole Cream 1% |
|---|---|
| Muscle strainInjury, poisoning and procedural complications | 1/20 |
| Alanine aminotransferase increasedInvestigations | 1/20 |
| Aspartate Aminotransferase increasedInvestigations | 1/20 |
| Hemoglobin decreasedInvestigations | 1/20 |
| Back painMusculoskeletal and connective tissue disorders | 1/20 |
All participants who received at least 1 application of study drug and had at least 1 post-Baseline assessment.
| Age, Continuous(years) | Luliconazole Cream 1% |
|---|---|
| Mean | 45.05 ± 10.47 |
| Sex: Female, Male(Participants) | Luliconazole Cream 1% |
|---|---|
| Female | 1 |
| Male | 19 |
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Luliconazole