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Antifungal

SKX-16 (Luliconazole 10% Solution) for Toenail Fungus

Phase 1
Waitlist Available
Research Sponsored by SATO Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 days
Awards & highlights

Study Summary

This trial is testing a new antifungal medication applied topically to the nails to treat toenail fungus.

Eligible Conditions
  • Toenail Fungus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK parameters for the systemic absorption of luliconazole - AUC0-24h
PK parameters for the systemic absorption of luliconazole - AUC0-∞
PK parameters for the systemic absorption of luliconazole - Cmax
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: SKX-16 (Luliconazole 10% Solution)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

SATO Pharmaceutical Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
134 Total Patients Enrolled
Brent Clary, CCRCStudy ChairClinical Research Coordinator J&S Studies, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies to partake in this trial?

"This trial is recruiting 20 individuals with a particular structure of toe nails aged 18-65. Criteria for enrolment include: persons of any gender, ethnicity and age bracket; visible signs of distal subungual onychomycosis in both great toenails plus at least four additional toes; evidence of fungal hyphae through KOH wet mount testing and positive fungi culture from one or more great toenails; serum creatinine levels lower than the upper limit of normal (ULN); AST/SGOT, ALT/SGPT, total bilirubin readings below ULN; female participants must"

Answered by AI

What is the capacity of this medical research project?

"This research initiative has concluded its patient recruitment and the trial was originally posted on September 13th 2021, with a final edit made on June 13th 2022. There are 9 studies that remain active for "structure of nail of toe" and 1 study where SKX-16 (Luliconazole 10% Solution) is being utilized."

Answered by AI

Are there any prior investigations associated with SKX-16 (Luliconazole 10% Solution)?

"Currently, there is just one active clinical trial focusing on SKX-16 (Luliconazole 10% Solution) and it has not yet entered Phase 3. Primarily located in College Station, Texas, the research for this drug is being conducted at a single location."

Answered by AI

Could you provide an assessment of the security profile associated with SKX-16 (Luliconazole 10% Solution)?

"This Phase 1 trial has limited evidence of both efficacy and safety, so our team assigned SKX-16 (Luliconazole 10% Solution) a rating of 1."

Answered by AI

Are candidates of a certain age excluded from this research endeavor?

"This clinical trial requires that participants be at least 18 years old and not exceed the age of 65."

Answered by AI

Are there opportunities for individuals to be involved in this experiment currently?

"According to clinicaltrials.gov, this experiment is no longer recruiting patients; the original post was published in September 2021 and then last updated in June 2022. Even though there are no active recruitment efforts at this time, 10 other trials have open slots for participants."

Answered by AI

Is this clinical trial a pioneering endeavor?

"Presently, there is only one active clinical trial for SKX-16 (Luliconazole 10% Solution) occuring in a single city and country. Initially conducted in 2021 by SATO Pharmaceutical Co., Ltd., the Phase 1 drug approval stage concluded with 20 participants. Since then, 6 more trials have been successfully completed."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
J&S Studies, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
~6 spots leftby Apr 2025