Study Evaluating the Effect of Jublia on Dermatophytomas

NCT03098615 | Completed Phase 4 Results FDA Drug

• 1 other identifier: F150408010
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine how Jublia affects dermatophytomas, which are difficult to treat with other therapeutic options.

Conditions

Onychomycosis; Dermatophytosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO)

  Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.

  week 48

Secondary Outcomes (1)

• Clinical or Mycological Cure of Nail

  week 48

Study Arms (1)

Jublia (Efinaconazole 10% Topical Solution) + nail polish

OTHER

Subjects with distal lateral subungual onychomycosis (DLSO) with dermatophytoma.

Drug: Jublia (Efinaconazole 10% Topical Solution)

Interventions

Jublia (Efinaconazole 10% Topical Solution) DRUG

Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.

Also known as: Jublia

Jublia (Efinaconazole 10% Topical Solution) + nail polish

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has the informed consent been signed and patient's questions answered.
• Age \>= 18
• Patient willing and able to participate for the full duration of the study
• No onychomycosis
• Greater than 4 weeks from prior major surgery for any indication
• Willing to abstain from:
• The application of other topical medications or cosmetic products to the toenail Professional pedicures for the duration of the study. - Females of childbearing potential must: Have been using adequate contraception (abstinence, intrauterine device (IUD), birth control pills or spermicidal gel with diaphragm or condom) since their last menses Agree to continue using adequate means of contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) for the duration of study participation
• Females are not considered to be of childbearing potential if they are at least 1 year postmenopausal or have had a tubal ligation, bilateral oophorectomy or hysterectomy.

You may not qualify if:

• Active onychomycosis of the toenails or fingernails
• Any of the following in the 4 weeks (or as indicated) prior to randomization:
• Major surgery for any indication
• \- Any personal history of: Invasive cancer diagnosed or treated within the past 5 years. Participants who have been in remission for 5 years or more and have not required treatment in the past 5 years may be eligible if the principal investigator believes there is little to no risk of recurrence.
• Concurrent use of the following medications or treatments Other topical antifungals for any concomitant infection
• Females who are pregnant or lactating. Should a woman become pregnant or suspect she is pregnant while she is participating in this study she should notify the study physician immediately.
• Uncontrolled concurrent illness including ongoing or active infection, psychiatric illness/social situations that would limit compliance with study requirements or other underlying serious medical condition which, in the investigator's opinion, might preclude study participation.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The Kirklin Clinic

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Onychomycosis; Tinea

Interventions

efinaconazole; Solutions

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Leslie Roop
• Organization: UAB

lmroop@uabmc.edu

2059754917

Study Officials

• Boni E Elewski, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Topical application of Jublia (Efinaconazole 10% Topical Solution) to patients with distal lateral subungual onychomycosis with dermatophytoma.

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: April 4, 2017
• Study Start: September 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2018
• Last Updated: December 10, 2019
• Results First Posted: March 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)