TDT 067 Onychomycosis Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Celtic Pharma Development Services.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Celtic Pharma Development Services
ClinicalTrials.gov Identifier:
NCT01145807
First received: March 19, 2010
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Onychomycosis
Drug: TDT067
Drug: Placebo
Drug: Transfersome
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Celtic Pharma Development Services:

Primary Outcome Measures:
  • Cure Rate [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 60 Weeks ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 738
Study Start Date: April 2010
Estimated Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
non Transfersome® placebo
Drug: Placebo
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.
Sham Comparator: Transfersome® vehicle
Transfersome® vehicle
Drug: Transfersome
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.
Experimental: TDT 067
TDT 067
Drug: TDT067
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.

  2. 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.
  3. Patients must be able to understand the requirements of the study, abide by the restrictions, and return for all of the required examinations.
  4. Patients must be willing to sign a statement of informed consent.
  5. Patients must have a target great toenail with the capability to grow as determined by history of nail cutting.
  6. 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:

  1. Patients who have been treated with an investigational drug within 1 month prior to study start.
  2. Patients who are pregnant or planning to become pregnant or who are lactating.
  3. Patients with hypersensitivity to terbinafine or to any other ingredients of the formulation.
  4. Patients who are unable to spray their toenails and the surrounding tissues on the affected foot without assistance.
  5. Patients with symptomatic tinea pedis requiring treatment.
  6. Patients using oral terbinafine within 6 months prior to the start of study; patients who have received other oral antifungals within 3 months.
  7. 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.
  8. 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.
  9. Patients with superficial white or proximal subungual onychomycosis.
  10. Patients with a toenail infection involving a non dermatophyte alone.
  11. Patients with involvement of the matrix (lunula) or the proximal 2 mm of nail as measured from the proximal nail fold.
  12. 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.
  13. Patients with yellow streaks or dermatophytoma of the target toenail.
  14. Patients with a history of peripheral arterial disease or diabetes mellitus.
  15. Patients with any condition that in the opinion of the Investigator renders the patient unsuitable for participation in this study.
  16. 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.
  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: NCT01145807

Locations
United States, New Mexico
Academic Dermatology Associates
Albequerque, New Mexico, United States, 87106
Sponsors and Collaborators
Celtic Pharma Development Services
PPD
Investigators
Principal Investigator: Eduardo Tschen, MD Academic Dermatology Associates
  More Information

No publications provided

Responsible Party: Celtic Pharma Development Services
ClinicalTrials.gov Identifier: NCT01145807     History of Changes
Other Study ID Numbers: CL-067-III-01
Study First Received: March 19, 2010
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celtic Pharma Development Services:
Distal Subungual Toenail Onychomycosis

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

ClinicalTrials.gov processed this record on October 29, 2014