Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris
Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02767271
Collaborator
(none)
30
2
2
4.8
15
3.1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Study to Assess the Pharmacokinetics With Maximal Use of Luliconazole Cream 1% in Pediatric Patients With Moderate to Severe Tinea Pedis or Tinea Cruris
Actual Study Start Date
:
Dec 2, 2015
Actual Primary Completion Date
:
Apr 27, 2016
Actual Study Completion Date
:
Apr 27, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tinea Pedis 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%
Luliconazole cream will be applied topically per schedule specified in the arms.
|
| Experimental: Tinea Cruris 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.
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Participants (or legal guardian) with the ability and willingness to sign a written informed consent.
-
Participants of either gender at least 12 years to <18 years old (12 to 17 years, inclusive).
-
Participants with a mycological diagnosis of tinea pedis or tinea cruris confirmed by the detection of fungal hyphae on a microscopic potassium hydroxide (KOH) wet mount.
-
Participants with the ability and willingness to follow all study procedures, attend all scheduled visits, have all blood draws, and successfully complete the study.
-
Participants must be in good general health and free of any disease that in the Investigator's opinion might interfere with the study evaluations.
-
Participants must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.
Key Exclusion Criteria:
-
Participants with both tinea pedis and tinea cruris.
-
Participants with active atopic or contact dermatitis in the treatment area.
-
Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial. Participants who test positive for pregnancy after start of test treatment will be discontinued from test treatment but will be followed for safety purposes.
-
Participants who are immunocompromised (due to disease, for example; human immunodeficiency virus [HIV] or medications).
-
Participants who have a recent history of or current drug or alcohol abuse.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Valeant Site 01 | Santo Domingo | Dominican Republic | 10700 | |
| 2 | Valeant Site 02 | San Pedro Sula | Honduras | CT1100 |
Sponsors and Collaborators
- Bausch Health Americas, Inc.
Investigators
- Study Director: Anya Loncaric, Valeant Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT02767271
Other Study ID Numbers:
- V01-LUZA-401
First Posted:
May 10, 2016
Last Update Posted:
Nov 27, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Tinea Pedis | Tinea Cruris |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| 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 |
Baseline Characteristics
| Arm/Group Title | Tinea Pedis | Tinea Cruris | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 15 | 15 | 30 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
14.13
(2.17)
|
15.27
(1.49)
|
14.70
(1.91)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2
13.3%
|
5
33.3%
|
7
23.3%
|
| Male |
13
86.7%
|
10
66.7%
|
23
76.7%
|
Outcome Measures
| Title | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Tinea Pedis |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 15 |
| Mean (Standard Deviation) [nanograms/milliliter (ng/mL)] |
3.27
(1.71)
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Tinea Pedis |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 15 |
| Mean (Standard Deviation) [nanograms*hour/milliliter (ng*hr/mL)] |
60.38
(37.92)
|
| Title | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Tinea Pedis |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 0 |
| Title | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Tinea Cruris |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 15 |
| Mean (Standard Deviation) [ng/mL] |
15.40
(13.62)
|
| Title | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Tinea Cruris |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 15 |
| Mean (Standard Deviation) [ng*hr/mL] |
266.06
(236.07)
|
| Title | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Tinea Cruris |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 3 |
| Mean (Standard Deviation) [hours] |
49.77
(22.74)
|
Adverse Events
| Time Frame | Baseline (Day 1) up to Day 16 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population included all participants who were enrolled and received at least 1 application of study drug. | |||
| Arm/Group Title | Tinea Pedis | Tinea Cruris | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Tinea Pedis | Tinea Cruris | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Tinea Pedis | Tinea Cruris | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 0/15 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Tinea Pedis | Tinea Cruris | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/15 (13.3%) | 1/15 (6.7%) | ||
| Gastrointestinal disorders | ||||
| Diarrhea | 1/15 (6.7%) | 0/15 (0%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 0/15 (0%) | 1/15 (6.7%) | ||
| Nervous system disorders | ||||
| Headache | 1/15 (6.7%) | 0/15 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Please contact Sponsor directly for additional information.
Results Point of Contact
| Name/Title | Director of Clinical Operations |
|---|---|
| Organization | Bausch Health Americas, Inc |
| Phone | |
| aloncaric@bauschhealth.com |
Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT02767271
Other Study ID Numbers:
- V01-LUZA-401
First Posted:
May 10, 2016
Last Update Posted:
Nov 27, 2019
Last Verified:
Nov 1, 2019