NCT01484145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 19, 2012

Status Verified

October 1, 2012

Enrollment Period

3 months

First QC Date

November 28, 2011

Last Update Submit

October 18, 2012

Conditions

Onychomycosis

Keywords

OnychomycosisNail fungusTinea Unguium

Outcome Measures

Primary Outcomes (2)

  • Level of terbinafine in the nail bed (ng/mg)

    Day 28

  • Plasma terbinafine levels (ng/ml)

    Day 28

Secondary Outcomes (1)

  • Number of treatment emergent adverse events (AEs)& Serious Adverse Events (SAEs)

    60 days

Study Arms (5)

6 mA.min, 20 mins

ACTIVE COMPARATOR
Drug: Terbinafine HCl

6 mA/min, 20 mins, clamping

EXPERIMENTAL
Drug: Terbinafine HCl

6 mA/min, 20 mins, debridement, clamping

EXPERIMENTAL
Drug: Terbinafine HCl

15 mA/min, 30 mins, clamping

EXPERIMENTAL
Drug: Terbinafine HCl

15 mA/min, 50 mins, debridement, clamping

EXPERIMENTAL
Drug: Terbinafine HCl

Interventions

Terbinafine HClDRUG

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

15 mA/min, 30 mins, clamping15 mA/min, 50 mins, debridement, clamping6 mA.min, 20 mins6 mA/min, 20 mins, clamping6 mA/min, 20 mins, debridement, clamping

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive KOH
  • % 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cetero Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2011

First Posted

December 2, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

October 19, 2012

Record last verified: 2012-10

Locations

US(1)