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

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ClinicalTrials.gov Identifier: NCT02767271
Recruitment Status : Completed
First Posted : May 10, 2016
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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
Tinea Pedis Tinea Cruris Drug: Luliconazole Cream 1% Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : December 2, 2015
Actual Primary Completion Date : April 27, 2016
Actual Study Completion Date : April 27, 2016

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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.




Primary Outcome Measures :
  1. Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole [ Time Frame: 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.

  2. 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 [ Time Frame: 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.

  3. Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole [ Time Frame: 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.

  4. Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole [ Time Frame: 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.

  5. Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole [ Time Frame: 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.

  6. Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole [ Time Frame: 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.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767271


Locations
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Dominican Republic
Valeant Site 01
Santo Domingo, Dominican Republic, 10700
Honduras
Valeant Site 02
San Pedro Sula, Honduras, CT1100
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Anya Loncaric Valeant Pharmaceuticals
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02767271    
Other Study ID Numbers: V01-LUZA-401
First Posted: May 10, 2016    Key Record Dates
Results First Posted: November 27, 2019
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tinea
Tinea Pedis
Tinea cruris
Dermatomycoses
Mycoses
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Intertrigo
Dermatitis
Skin Diseases, Eczematous
Luliconazole
Antifungal Agents
Anti-Infective Agents