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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01484145
First received: November 28, 2011
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Onychomycosis
Drug: Terbinafine HCl
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Unblinded Clinical Trial to Evaluate the Deposition of Terbinafine in the Nail Bed After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail

Resource links provided by NLM:


Further study details as provided by Nitric BioTherapeutics, Inc:

Primary Outcome Measures:
  • Level of terbinafine in the nail bed (ng/mg) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Plasma terbinafine levels (ng/ml) [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of treatment emergent adverse events (AEs)& Serious Adverse Events (SAEs) [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: December 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 6 mA.min, 20 mins Drug: Terbinafine HCl
4% w/w terbinafine HCL gel, single dose,
Experimental: 6 mA/min, 20 mins, clamping Drug: Terbinafine HCl
4% w/w terbinafine HCL gel, single dose,
Experimental: 6 mA/min, 20 mins, debridement, clamping Drug: Terbinafine HCl
4% w/w terbinafine HCL gel, single dose,
Experimental: 15 mA/min, 30 mins, clamping Drug: Terbinafine HCl
4% w/w terbinafine HCL gel, single dose,
Experimental: 15 mA/min, 50 mins, debridement, clamping Drug: Terbinafine HCl
4% w/w terbinafine HCL gel, single dose,

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484145

Locations
United States, Texas
Cetero Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Nitric BioTherapeutics, Inc
  More Information

No publications provided

Responsible Party: Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier: NCT01484145     History of Changes
Other Study ID Numbers: CTP-10
Study First Received: November 28, 2011
Last Updated: October 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nitric BioTherapeutics, Inc:
Onychomycosis
Nail fungus
Tinea Unguium

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Terbinafine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014