Trial · NCT02767947
Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis
NCT02767947, 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. Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis. Trials, record NCT02767947. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02767947
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis
- NCT number
- NCT02767947
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 75 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Tinea Corporis
- Interventions
- Luliconazole Cream 1%, Vehicle Cream
- First posted
- 2016-05-11
- Last updated
- 2019-11-27
- Results first posted
- 2019-11-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose) | Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7 | Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the time of maximum concentration (tmax) (6 hours after the final dose of study drug on Day 7). |
| Primary | Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose) | 6 hours after the final dose of the drug on Day 7 | Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the tmax (6 hours after the final dose of study drug on Day 7). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose) | Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7 | PK population included all randomized participants who received at least 1 application of study drug, and from whom blood samples were obtained for plasma level analysis both prior to (within 15 minutes) and 6 hours after the final dose (on Day 7). | nanograms/milliliter (ng/mL) | MEAN |
| PRIMARY | Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose) | 6 hours after the final dose of the drug on Day 7 | PK population included all randomized participants who received at least 1 application of study drug, and from whom blood samples were obtained for plasma level analysis both prior to (within 15 minutes) and 6 hours after the final dose (on Day 7). | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose) | Luliconazole Cream 1% | 4.63 | Standard Deviation 2.93 | nanograms/milliliter (ng/mL) | |
| Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose) | Vehicle Cream | NA | Standard Deviation NA | nanograms/milliliter (ng/mL) | |
| Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose) | Luliconazole Cream 1% | 4.84 | Standard Deviation 3.33 | ng/mL | |
| Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose) | Vehicle Cream | 0.07 | Standard Deviation 0.12 | ng/mL |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Luliconazole Cream 1% | 60 | |
| Overall Study | STARTED | Vehicle Cream | 15 | |
| Overall Study | Safety Population | Luliconazole Cream 1% | 60 | |
| Overall Study | Safety Population | Vehicle Cream | 15 | |
| Overall Study | Pharmacokinetic (PK) Population | Luliconazole Cream 1% | 12 | |
| Overall Study | Pharmacokinetic (PK) Population | Vehicle Cream | 3 | |
| Overall Study | COMPLETED | Luliconazole Cream 1% | 60 | |
| Overall Study | COMPLETED | Vehicle Cream | 15 | |
| Overall Study | NOT COMPLETED | Luliconazole Cream 1% | 0 | |
| Overall Study | NOT COMPLETED | Vehicle Cream | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Nasopharyngitis | Infections and infestations | Luliconazole Cream 1% | 4 | 60 | |
| other | Nasopharyngitis | Infections and infestations | Vehicle Cream | 2 | 15 | |
| other | Headache | Nervous system disorders | Luliconazole Cream 1% | 3 | 60 | |
| other | Headache | Nervous system disorders | Vehicle Cream | 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 | Luliconazole Cream 1% | ||
| Total, all-cause mortality | Vehicle Cream | ||
| Total, other adverse events | Luliconazole Cream 1% | 7 | 60 |
| Total, other adverse events | Vehicle Cream | 2 | 15 |
| Total, serious adverse events | Luliconazole Cream 1% | 0 | 60 |
| Total, serious adverse events | Vehicle Cream | 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 |
|---|
| Luliconazole Cream 1% vs Vehicle Cream: 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/NCT02767947
GET https://conductscience.org/api/trials/v1/NCT02767947/registered