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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02767271
Other study ID # V01-LUZA-401
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2, 2015
Est. completion date April 27, 2016

Study information

Verified date November 2019
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 27, 2016
Est. primary completion date April 27, 2016
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Luliconazole Cream 1%
Luliconazole cream will be applied topically per schedule specified in the arms.

Locations

Country Name City State
Dominican Republic Valeant Site 01 Santo Domingo
Honduras Valeant Site 02 San Pedro Sula

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

Dominican Republic,  Honduras, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
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 Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method. Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Primary 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. Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Primary 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. Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Primary 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. Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Primary 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. Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
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