Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of HTU-520 in subjects with clinically diagnosed onychomycosis of the great toenail.

Detailed Description
-----------------
A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety & Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

Official Title
-----------------
A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety & Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Drug: HTU-520 Patch
* Other: Placebo Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of DSO for at least one great toenail Direct microscopy of subungual debris positive for hyphal elements (KOH test) Culture confirmation of the growth of a dermatophyte Good general health Willing to refrain from using any lotions, creams, liquids, or polish on treated toenails Willing to refrain from receiving pedicures for the duration of the study If female, using an acceptable form of birth control Exclusion Criteria: Unable to apply test product onto toenails by him/herself Use of topical antifungal agents on the nail within 1 month Uncontrolled diabetes Onychomycosis of the fingernails Confirmed non-dermatophyte infection of the target toenail Structural deformities of the target toenail, open wounds, lesions, sores, surgery on the feet or toenails History of severe or chronic immunosuppression, an immunocompromised condition Any systemic or dermatologic disorder, such as severe eczema, or severe atopic dermatitis Psoriasis of the toenails Hypersensitivity or allergy to topical preparations (including terbinafine) or adhesive dressings

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HTU-520 Patch<br>Subjects will receive HTU-520 patch in a 1:1 ratio for 48 weeks applied to all toenails. | Drug: HTU-520 Patch<br>* Terbinafine hydrochloride patch<br>* Other names: HTU-520;|
| Placebo Comparator: Placebo Patch<br>Subjects will receive placebo patch in a 1:1 ratio for 48 weeks applied to all toenails. | Other: Placebo Patch<br>* Treatment with Placebo Patch<br>* Other names: Sham treatment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail. |  | 48 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Onychomycosis