Deposition of Terbinafine After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail

NCT ID: NCT01484145

Last Updated: 2012-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-04-30

Brief Summary

The purpose of this study is to determine how much terbinafine is delivered to the nail bed after treatment with a number of modifications to a previously studied method for iontophoretic delivery of terbinafine gel. Iontophoretic delivery involves the use of a small electric charge to deliver drug across skin and nails.

Conditions

Onychomycosis

Keywords

Onychomycosis; Nail fungus; Tinea Unguium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6 mA.min, 20 mins

Group Type: ACTIVE_COMPARATOR

Terbinafine HCl

Intervention Type: DRUG

4% w/w terbinafine HCL gel, single dose,

6 mA/min, 20 mins, clamping

Group Type: EXPERIMENTAL

Terbinafine HCl

Intervention Type: DRUG

4% w/w terbinafine HCL gel, single dose,

6 mA/min, 20 mins, debridement, clamping

Group Type: EXPERIMENTAL

Terbinafine HCl

Intervention Type: DRUG

4% w/w terbinafine HCL gel, single dose,

15 mA/min, 30 mins, clamping

Group Type: EXPERIMENTAL

Terbinafine HCl

Intervention Type: DRUG

4% w/w terbinafine HCL gel, single dose,

15 mA/min, 50 mins, debridement, clamping

Group Type: EXPERIMENTAL

Terbinafine HCl

Intervention Type: DRUG

4% w/w terbinafine HCL gel, single dose,

Interventions

Terbinafine HCl

4% w/w terbinafine HCL gel, single dose,

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Positive KOH
• 25-75% involvement of the visible nail.
• Nail plate must be < 3 mm thick.
• Must have signed informed consent.
• Must agree to avoid any type of pedicure or application of any nail polish product or nail cosmetic to the toenails after the screening visit until Day 28.
• Female subjects of childbearing potential must agree to take measures to avoid pregnancy until the day after Day 28
• Must agree to avoid the use of oral antifungals or topical terbinafine anywhere on the body until the day after Day 28. Topical antifungals other than terbinafine can be used on the body other than the feet after Day 0.

Exclusion Criteria

• Presence of proximal subungual onychomycosis or white superficial onychomycosis
• Fungal involvement of a majority of the lunula
• Subjects with psoriasis, eczema, or other abnormalities that could result in a clinically abnormal nail
• Presence of dermatophytoma or onychomycotic spikes or exclusively lateral groove involvement
• Traumatized or dystrophic target great toenail.
• Known diabetics
• Subjects with peripheral vascular disease
• Subjects who are immunosuppressed (chronic corticosteroid therapy, solid organ or bone marrow transplantation, cytotoxic chemotherapy within the previous 12 months (or planned within the next 12 months), or HIV infection.
• Use of systemic corticosteroids within 30 days preceding Day 0
• Use of topical antifungals on the feet in the preceding 30 days of Day 0 through Day 28
• Use of topical terbinafine in the 30 days prior to treatment through Day 28
• Use of systemic antifungals in the preceding 120 days of Day 0 through Day 28
• Use of any investigational drug(s) within 30 days (120 days for systemic antifungals) preceding Day 0 through Day 28
• Has previously participated in this study
• Is pregnant or is a nursing mother
• Women of of child bearing potential who are not using an adequate form of contraception (or abstinence)
• Subjects with pacemakers/automatic implantable cardioverter/defibrillators
• Subjects with an implantable electronic device.
• Subjects with a bleeding disorder or who are using warfarin or any other blood coagulation modulator including aspirin in the 14 days prior to treatment through Day 28

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nitric BioTherapeutics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cetero Research

San Antonio, Texas, United States

Countries

United States

Other Identifiers

CTP-10

Identifier Type: -

Identifier Source: org_study_id