TDT 067 Onychomycosis Study
Primary Purpose
Onychomycosis
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TDT067
Placebo
Transfersome
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis focused on measuring Distal Subungual Toenail Onychomycosis
Eligibility Criteria
Inclusion Criteria:
Patients must be between 18 and 75 years of age inclusive, of any race, and of either sex.
Female patients must be either surgically sterile, postmenopausal (no menses for the previous 12 months), or must be practicing an effective method of birth control as determined by the Investigator.
- Patients must have at least 1 great toenail (target toenail) with clinically diagnosed distal subungual onychomycosis involving between 25% and 65%, inclusive, of the nail and confirmed by KOH visualization and fungal culture positive for dermatophytes. (Patients with culture positive for dermatophytes alone or dermatophytes and non dermatophytes are eligible to participate.) If both great toenails meet inclusion criteria, the one with the greater involvement will be designated the target nail.
- Patients must be able to understand the requirements of the study, abide by the restrictions, and return for all of the required examinations.
- Patients must be willing to sign a statement of informed consent.
- Patients must have a target great toenail with the capability to grow as determined by history of nail cutting.
- Patients must be willing to refrain from using any nail polish products and other nail cosmetic products on any of the toenails and must be willing to refrain from professional pedicures for the duration of this study.
Exclusion Criteria:
- Patients who have been treated with an investigational drug within 1 month prior to study start.
- Patients who are pregnant or planning to become pregnant or who are lactating.
- Patients with hypersensitivity to terbinafine or to any other ingredients of the formulation.
- Patients who are unable to spray their toenails and the surrounding tissues on the affected foot without assistance.
- Patients with symptomatic tinea pedis requiring treatment.
- Patients using oral terbinafine within 6 months prior to the start of study; patients who have received other oral antifungals within 3 months.
- Patients using topical antifungal treatments for onychomycosis within 1 month prior to the start of study; patients using topical antifungal treatments for the feet within 1 month prior to the start of the study.
- Patients with any nail dystrophy that will interfere with the assessment of a clear nail. Patients who have toenail abnormalities or dystrophies that could prevent the restoration of a normal appearing nail in spite of a mycological cure for dermatophytes, including patients with psoriasis, lichen planus, malignancy or pigmentation disorders involving the nail unit, chemical damage, or onychodystrophy due to trauma or other structural deformities.
- Patients with superficial white or proximal subungual onychomycosis.
- Patients with a toenail infection involving a non dermatophyte alone.
- Patients with involvement of the matrix (lunula) or the proximal 2 mm of nail as measured from the proximal nail fold.
- Patients who have a nail plate with thickness greater than 2 mm or total thickness of the nail plus subungual debris measuring greater than 3 mm.
- Patients with yellow streaks or dermatophytoma of the target toenail.
- Patients with a history of peripheral arterial disease or diabetes mellitus.
- Patients with any condition that in the opinion of the Investigator renders the patient unsuitable for participation in this study.
- Patients with alanine aminotransferase (ALT) or aspartate (AST) levels greater than 2 times the upper limit of normal without clinical reason, unless, in the opinion of the Investigator, participation in this study would not place the patient at undue risk.
Sites / Locations
- Academic Dermatology Associates
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Sham Comparator
Experimental
Arm Label
Placebo
Transfersome® vehicle
TDT 067
Arm Description
non Transfersome® placebo
Transfersome® vehicle
TDT 067
Outcomes
Primary Outcome Measures
Cure Rate
To compare complete cure rates for onychomycosis at Week 52 for TDT 067 versus non-Transfersome placebo.
If the comparison between TDT 067 and non-Transfersome placebo is statistically significant in favor of TDT 067, the following additional primary efficacy objective:
To compare onychomycosis cure rates at Week 52 for TDT 067 versus Transfersome vehicle
Secondary Outcome Measures
Cure Rate 48
Compare onychomycosis complete cure rates at Wk 48 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare effective treatment rates at Wk 48 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare mycological cure rates at Wk 48 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare complete cure rates at Wk 48 effective treatment rates at Wks 48, and mycological cure rates at Wks 48 for Transfersome® vehicle versus non Transfersome® placebo
Cure Rate 52
Compare onychomycosis complete cure rates at Wk 52 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare effective treatment rates at Wk 52 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare mycological cure rates at Wk 52 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare complete cure rates at Wk 52 effective treatment rates at Wk 52 and mycological cure rates at Wk 52 for Transfersome® vehicle versus non Transfersome® placebo
Cure Rate 60
Compare onychomycosis complete cure rates at Wk 60 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare effective treatment rates at Wk 60 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare mycological cure rates at Wk 60 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare complete cure rates at Wk 60, effective treatment rates at Wk 60, and mycological cure rates at Wk 60 for Transfersome® vehicle versus non Transfersome® placebo
Full Information
NCT ID
NCT01145807
First Posted
March 19, 2010
Last Updated
July 31, 2012
Sponsor
Celtic Pharma Development Services
Collaborators
PPD
1. Study Identification
Unique Protocol Identification Number
NCT01145807
Brief Title
TDT 067 Onychomycosis Study
Official Title
A Randomized, Double-blind, Vehicle- and Placebo-Controlled, Multicenter Trial in Patients With Mild to Moderate Distal Subungual Toenail Onychomycosis to Investigate the Efficacy, Tolerability, and Safety of Twice Daily Application of TDT 067 for 48 Weeks
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celtic Pharma Development Services
Collaborators
PPD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to establish the efficacy, clinical benefits, and safety of treatment with TDT 067 for clinically diagnosed distal subungual onychomycosis of the toenails caused by dermatophytes confirmed by positive mycology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
Distal Subungual Toenail Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
738 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
non Transfersome® placebo
Arm Title
Transfersome® vehicle
Arm Type
Sham Comparator
Arm Description
Transfersome® vehicle
Arm Title
TDT 067
Arm Type
Experimental
Arm Description
TDT 067
Intervention Type
Drug
Intervention Name(s)
TDT067
Intervention Description
Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application.
Intervention Type
Drug
Intervention Name(s)
Transfersome
Intervention Description
Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application.
Primary Outcome Measure Information:
Title
Cure Rate
Description
To compare complete cure rates for onychomycosis at Week 52 for TDT 067 versus non-Transfersome placebo.
If the comparison between TDT 067 and non-Transfersome placebo is statistically significant in favor of TDT 067, the following additional primary efficacy objective:
To compare onychomycosis cure rates at Week 52 for TDT 067 versus Transfersome vehicle
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Cure Rate 48
Description
Compare onychomycosis complete cure rates at Wk 48 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare effective treatment rates at Wk 48 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare mycological cure rates at Wk 48 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare complete cure rates at Wk 48 effective treatment rates at Wks 48, and mycological cure rates at Wks 48 for Transfersome® vehicle versus non Transfersome® placebo
Time Frame
48 Weeks
Title
Cure Rate 52
Description
Compare onychomycosis complete cure rates at Wk 52 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare effective treatment rates at Wk 52 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare mycological cure rates at Wk 52 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare complete cure rates at Wk 52 effective treatment rates at Wk 52 and mycological cure rates at Wk 52 for Transfersome® vehicle versus non Transfersome® placebo
Time Frame
52 Weeks
Title
Cure Rate 60
Description
Compare onychomycosis complete cure rates at Wk 60 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare effective treatment rates at Wk 60 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare mycological cure rates at Wk 60 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle
Compare complete cure rates at Wk 60, effective treatment rates at Wk 60, and mycological cure rates at Wk 60 for Transfersome® vehicle versus non Transfersome® placebo
Time Frame
60 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be between 18 and 75 years of age inclusive, of any race, and of either sex.
Female patients must be either surgically sterile, postmenopausal (no menses for the previous 12 months), or must be practicing an effective method of birth control as determined by the Investigator.
Patients must have at least 1 great toenail (target toenail) with clinically diagnosed distal subungual onychomycosis involving between 25% and 65%, inclusive, of the nail and confirmed by KOH visualization and fungal culture positive for dermatophytes. (Patients with culture positive for dermatophytes alone or dermatophytes and non dermatophytes are eligible to participate.) If both great toenails meet inclusion criteria, the one with the greater involvement will be designated the target nail.
Patients must be able to understand the requirements of the study, abide by the restrictions, and return for all of the required examinations.
Patients must be willing to sign a statement of informed consent.
Patients must have a target great toenail with the capability to grow as determined by history of nail cutting.
Patients must be willing to refrain from using any nail polish products and other nail cosmetic products on any of the toenails and must be willing to refrain from professional pedicures for the duration of this study.
Exclusion Criteria:
Patients who have been treated with an investigational drug within 1 month prior to study start.
Patients who are pregnant or planning to become pregnant or who are lactating.
Patients with hypersensitivity to terbinafine or to any other ingredients of the formulation.
Patients who are unable to spray their toenails and the surrounding tissues on the affected foot without assistance.
Patients with symptomatic tinea pedis requiring treatment.
Patients using oral terbinafine within 6 months prior to the start of study; patients who have received other oral antifungals within 3 months.
Patients using topical antifungal treatments for onychomycosis within 1 month prior to the start of study; patients using topical antifungal treatments for the feet within 1 month prior to the start of the study.
Patients with any nail dystrophy that will interfere with the assessment of a clear nail. Patients who have toenail abnormalities or dystrophies that could prevent the restoration of a normal appearing nail in spite of a mycological cure for dermatophytes, including patients with psoriasis, lichen planus, malignancy or pigmentation disorders involving the nail unit, chemical damage, or onychodystrophy due to trauma or other structural deformities.
Patients with superficial white or proximal subungual onychomycosis.
Patients with a toenail infection involving a non dermatophyte alone.
Patients with involvement of the matrix (lunula) or the proximal 2 mm of nail as measured from the proximal nail fold.
Patients who have a nail plate with thickness greater than 2 mm or total thickness of the nail plus subungual debris measuring greater than 3 mm.
Patients with yellow streaks or dermatophytoma of the target toenail.
Patients with a history of peripheral arterial disease or diabetes mellitus.
Patients with any condition that in the opinion of the Investigator renders the patient unsuitable for participation in this study.
Patients with alanine aminotransferase (ALT) or aspartate (AST) levels greater than 2 times the upper limit of normal without clinical reason, unless, in the opinion of the Investigator, participation in this study would not place the patient at undue risk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Tschen, MD
Organizational Affiliation
Academic Dermatology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Dermatology Associates
City
Albequerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
12. IPD Sharing Statement
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TDT 067 Onychomycosis Study
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