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Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02767947
Recruitment Status : Completed
First Posted : May 11, 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 was to evaluate the safety, efficacy, and pharmacokinetics of luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to 17 years of age (inclusive) with tinea corporis.

Condition or disease Intervention/treatment Phase
Tinea Corporis Drug: Luliconazole Cream 1% Drug: Vehicle Cream Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Product 33525 in Pediatric Subjects With Tinea Corporis
Actual Study Start Date : February 8, 2016
Actual Primary Completion Date : June 29, 2016
Actual Study Completion Date : September 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections

Arm Intervention/treatment
Experimental: Luliconazole Cream 1%
Luliconazole cream 1% will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
Drug: Luliconazole Cream 1%
Luliconazole cream will be applied per schedule specified in the arm.
Other Name: Product 33525

Placebo Comparator: Vehicle Cream
Vehicle cream (containing no active ingredient) will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
Drug: Vehicle Cream
Vehicle cream will be applied per schedule specified in the arm.




Primary Outcome Measures :
  1. Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose) [ Time Frame: 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).

  2. Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose) [ Time Frame: 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).



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Participants (or legal guardian/caregiver) with the ability and willingness to sign a written informed consent and/or assent (age appropriate).
  • Participants of either gender must be at least 2 years to less than (<) 18 years of age (2 to 17 years, inclusive).
  • Participants with a clinical diagnosis of tinea corporis characterized by clinical evidence of a tinea infection (at least moderate erythema, mild scaling, and moderate pruritus).
  • 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/caregiver 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 active atopic or contact dermatitis in the area to be treated.
  • Participants with severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.
  • 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 study drug will be discontinued from study drug 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): NCT02767947


Locations
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Dominican Republic
Valeant Site 03
San Cristobal, Dominican Republic, 91000
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: NCT02767947    
Obsolete Identifiers: NCT02491112
Other Study ID Numbers: V01-LUZB-401
First Posted: May 11, 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
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Luliconazole
Antifungal Agents
Anti-Infective Agents