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:
Nitric BioTherapeutics, Inc
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
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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 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 May 19, 2013