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Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis

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ClinicalTrials.gov Identifier: NCT02812771
Recruitment Status : Active, not recruiting
First Posted : June 24, 2016
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
Safety and Pharmacokinetics (PK) of a once daily topical application of efinaconazole in the treatment of pediatric subjects with mild to severe onychomycosis of the toenails.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: Efinaconazole Phase 4

Detailed Description:
This is an open label, single-arm study designed to evaluate the safety and PK of a once daily topical application of efinaconazole in the treatment of pediatric subjects with mild to severe onychomycosis of the toenails.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Single-arm Study Evaluating the Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis of the Toenails
Actual Study Start Date : June 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Efinaconazole
Efinaconazole
Drug: Efinaconazole
Solution




Primary Outcome Measures :
  1. Adverse Events will be collected as spontaneous reports by the subjects and as observations by the investigators. . [ Time Frame: 48 weeks ]
    Measurements will be taken as; Local Skin Reactions (redness, swelling, burning, itching, and vesiculation) on a 4-point scale from none to severe. Blood and Urine samples will be collected for routine clinical laboratory tests (hematology, serum chemistry, and urinanalysis). And lastly vital sign measurements (blood pressure, respiration, pulse, and temperature.



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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Male or female subjects of any race, 6 to 16 years of age (inclusive). PK Subset: Male or female subjects of any race, 12 to 16 years of age (inclusive).
  • Verbal and written informed consent/assent obtained from the subject and/or their parent or legal guardian.
  • Good general health, as assessed by the investigator, based on the subject's medical history, physical examination, and safety laboratory tests.
  • Target great toenail for all subjects, and both great toenails for subjects in the PK subset, must have evidence of toenail growth, per subject's report that monthly clipping is needed.
  • Subjects and their parents/legal guardians are willing to comply with study instructions and return to the investigational center for all required visits (a visit schedule with the length of each visit will be provided to ensure that the subject can meet the requirements and have adequate transportation).

Key Exclusion Criteria:

  • Females who are pregnant, nursing an infant, or planning a pregnancy during the study period.
  • History of immunosuppression and/or clinical signs indicative of possible immunosuppression, as determined by the investigator, or known human immunodeficiency virus infection.
  • History of diabetes that is uncontrolled as determined by the investigator (diabetes that is controlled by diet or medication does not exclude a subject).
  • Presence of any toenail infection other than or in addition to dermatophytes, such as Scytalidium as determined by the investigator (candidal onychomycosis infection, concurrent with a positive dermatophyte culture, is acceptable).

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): NCT02812771


Locations
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United States, Alabama
Valeant Site 01
Birmingham, Alabama, United States, 35201
United States, California
Valeant Site 04
Fountain Valley, California, United States, 92708
Valeant Site 03
Santa Rosa, California, United States, 95403
United States, Florida
Valeant SIte 05
South Miami, Florida, United States, 33143
United States, Louisiana
Valeant Site 09
New Orleans, Louisiana, United States, 70130
United States, Maryland
Valeant Site 08
Baltimore, Maryland, United States, 21214
United States, New York
Valeant Site 02
Forest Hills, New York, United States, 11375
United States, Pennsylvania
Valeant Site 06
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Valeant Site 07
McAllen, Texas, United States, 78501
Dominican Republic
Valeant Site 10
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Binu Alexander, MD Valeant Pharmaceuticals

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02812771     History of Changes
Other Study ID Numbers: V01-108A-401
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Efinaconazole
Antifungal Agents
Anti-Infective Agents