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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01400594

Enrollment

182

Registered

2011-07-22

Start date

2011-07-31

Completion date

2013-01-31

Last updated

2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis

Keywords

Onychomycosis

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

Interventions

DRUGHTU-520 Patch

Terbinafine hydrochloride patch

OTHERPlacebo Patch

Treatment with Placebo Patch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Clinical diagnosis of DSO for at least one great toenail 2. Direct microscopy of subungual debris positive for hyphal elements (KOH test) 3. Culture confirmation of the growth of a dermatophyte 4. Good general health 5. Willing to refrain from using any lotions, creams, liquids, or polish on treated toenails 6. Willing to refrain from receiving pedicures for the duration of the study 7. If female, using an acceptable form of birth control

Exclusion criteria

1. Unable to apply test product onto toenails by him/herself 2. Use of topical antifungal agents on the nail within 1 month 3. Uncontrolled diabetes 4. Onychomycosis of the fingernails 5. Confirmed non-dermatophyte infection of the target toenail 6. Structural deformities of the target toenail, open wounds, lesions, sores, surgery on the feet or toenails 7. History of severe or chronic immunosuppression, an immunocompromised condition 8. Any systemic or dermatologic disorder, such as severe eczema, or severe atopic dermatitis 9. Psoriasis of the toenails 10. Hypersensitivity or allergy to topical preparations (including terbinafine) or adhesive dressings

Design outcomes

Primary

Measure	Time frame
Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.	48 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026