Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis
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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: NCT02812771 |
Recruitment Status :
Completed
First Posted : June 24, 2016
Last Update Posted : November 22, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Onychomycosis | Drug: Efinaconazole | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | N/A |
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 : | August 4, 2016 |
Actual Primary Completion Date : | January 14, 2019 |
Actual Study Completion Date : | January 14, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Efinaconazole
Efinaconazole
|
Drug: Efinaconazole
Solution |
- 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 |
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).

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
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 |
Study Director: | Binu Alexander, MD | Valeant Pharmaceuticals |
Responsible Party: | Bausch Health Americas, Inc. |
ClinicalTrials.gov Identifier: | NCT02812771 |
Other Study ID Numbers: |
V01-108A-401 |
First Posted: | June 24, 2016 Key Record Dates |
Last Update Posted: | November 22, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Onychomycosis Tinea Dermatomycoses Skin Diseases, Infectious Infection Mycoses |
Nail Diseases Skin Diseases Efinaconazole Antifungal Agents Anti-Infective Agents |