Trial · NCT02767271
Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris
NCT02767271, Phase 4, Completed, Bausch Health Americas, Inc.; results first posted 2019-11-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris. Trials, record NCT02767271. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02767271
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris
- NCT number
- NCT02767271
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 30 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Tinea Pedis, Tinea Cruris
- Interventions
- Luliconazole Cream 1%
- First posted
- 2016-05-10
- Last updated
- 2019-11-27
- Results first posted
- 2019-11-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 | Plasma concentration of luliconazole was determined using validated liquid chromatography-mass spectrometry (LC/MS) method. |
| Primary | 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 | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 | Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method. |
| Primary | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 | Plasma concentration of luliconazole was determined using validated LC/MS method. |
| Primary | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 | Plasma concentration of luliconazole was determined using validated LC/MS method. |
| Primary | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 | Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method. |
| Primary | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 | Plasma concentration of luliconazole was determined using validated LC/MS method. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 | PKP population included all participants with tinea pedis who were enrolled, received at least 1 application of study drug, and had at least 1 pharmacokinetic (PK) assessment. | nanograms/milliliter (ng/mL) | MEAN |
| PRIMARY | 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 | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 | PKP population included all participants with tinea pedis who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. | nanograms*hour/milliliter (ng*hr/mL) | MEAN |
| PRIMARY | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 | PKP population included all participants with tinea pedis who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. None of the participants in this population was evaluable for this outcome measure at specified timepoint. | ||
| PRIMARY | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 | PKC population included all participants with tinea cruris who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. | ng/mL | MEAN |
| PRIMARY | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 | PKC population included all participants with tinea cruris who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. | ng*hr/mL | MEAN |
| PRIMARY | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 | PKC population included all participants with tinea cruris who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | hours | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole | Tinea Pedis | 3.27 | Standard Deviation 1.71 | nanograms/milliliter (ng/mL) | |
| 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 | Tinea Pedis | 60.38 | Standard Deviation 37.92 | nanograms*hour/milliliter (ng*hr/mL) | |
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole | Tinea Cruris | 15.40 | Standard Deviation 13.62 | ng/mL | |
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole | Tinea Cruris | 266.06 | Standard Deviation 236.07 | ng*hr/mL | |
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole | Tinea Cruris | 49.77 | Standard Deviation 22.74 | hours |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tinea Pedis | 15 | |
| Overall Study | STARTED | Tinea Cruris | 15 | |
| Overall Study | Safety Population | Tinea Pedis | 15 | |
| Overall Study | Safety Population | Tinea Cruris | 15 | |
| Overall Study | Pharmacokinetic Pedis (PKP) Population | Tinea Pedis | 15 | |
| Overall Study | Pharmacokinetic Pedis (PKP) Population | Tinea Cruris | 0 | |
| Overall Study | Pharmacokinetic Cruris (PKC) Population | Tinea Pedis | 0 | |
| Overall Study | Pharmacokinetic Cruris (PKC) Population | Tinea Cruris | 15 | |
| Overall Study | COMPLETED | Tinea Pedis | 15 | |
| Overall Study | COMPLETED | Tinea Cruris | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Tinea Pedis | 1 | 15 | |
| other | Diarrhea | Gastrointestinal disorders | Tinea Cruris | 0 | 15 | |
| other | Nasopharyngitis | Infections and infestations | Tinea Pedis | 0 | 15 | |
| other | Nasopharyngitis | Infections and infestations | Tinea Cruris | 1 | 15 | |
| other | Headache | Nervous system disorders | Tinea Pedis | 1 | 15 | |
| other | Headache | Nervous system disorders | Tinea Cruris | 0 | 15 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tinea Pedis | ||
| Total, all-cause mortality | Tinea Cruris | ||
| Total, other adverse events | Tinea Pedis | 2 | 15 |
| Total, other adverse events | Tinea Cruris | 1 | 15 |
| Total, serious adverse events | Tinea Pedis | 0 | 15 |
| Total, serious adverse events | Tinea Cruris | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tinea Pedis vs Tinea Cruris: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02767271
GET https://conductscience.org/api/trials/v1/NCT02767271/registered