TDT 067 Onychomycosis Study

NCT01145807 | Unknown Phase 3

• 1 other identifier: CL-067-III-01
• Study Type: interventional
• Target: 738
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis

Keywords

Distal Subungual Toenail Onychomycosis

Outcome Measures

Primary Outcomes (1)

• 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

  52 Weeks

Secondary Outcomes (3)

• Cure Rate 48

  48 Weeks

• Cure Rate 52

  52 Weeks

• Cure Rate 60

  60 Weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

non Transfersome® placebo

Drug: Placebo

Transfersome® vehicle

SHAM COMPARATOR

Transfersome® vehicle

Drug: Transfersome

TDT 067

EXPERIMENTAL

TDT 067

Drug: TDT067

Interventions

TDT067 DRUG

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.

TDT 067

Placebo DRUG

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.

Placebo

Transfersome DRUG

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.

Transfersome® vehicle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celtic Pharma Development Services: lead
• PPD Development, LP: collaborator

Study Sites (1)

Academic Dermatology Associates

Albequerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Eduardo Tschen, MD

  Academic Dermatology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: June 17, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)