Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris

NCT02767271 | Completed Phase 4 Results

• 1 other identifier: V01-LUZA-401
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

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.

Conditions

Tinea Pedis; Tinea Cruris

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Tinea Pedis

EXPERIMENTAL

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%

Tinea Cruris

EXPERIMENTAL

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%

Interventions

Luliconazole Cream 1% DRUG

Luliconazole cream will be applied topically per schedule specified in the arms.

Tinea Cruris; Tinea Pedis

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (2)

Valeant Site 01

Santo Domingo, 10700, Dominican Republic

Location

Valeant Site 02

San Pedro Sula, CT1100, Honduras

Location

MeSH Terms

Conditions

Tinea Pedis; Tinea Cruris

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intertrigo; Dermatitis; Skin Diseases, Eczematous

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc

aloncaric@bauschhealth.com

Study Officials

• Anya Loncaric

  Valeant Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 10, 2016
• Study Start: December 2, 2015
• Primary Completion: April 27, 2016
• Study Completion: April 27, 2016
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1); DO (1)