NCT01145807

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

Status unknown Phase 3 Last updated 31 July 2012

What this trial tests

Phase 3 trial testing TDT067 in Onychomycosis in 738 participants. Status unknown.

Timeline

1 April 2010

Primary endpoint
1 February 2012

1 August 2012

Quick facts

Lead sponsor	Celtic Pharma Development Services
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	738
Start date	1 April 2010
Primary completion	1 February 2012
Estimated completion	1 August 2012
Sites	1 location across United States

Drugs / interventions tested

• TDT067 — full drug profile →
• Placebo
• Transfersome — full drug profile →

Conditions studied

• Onychomycosis — all drugs for Onychomycosis →

Sponsor

Celtic Pharma Development Services — full company profile →

Who can join

Adults 18 to 75, any sex, with Onychomycosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Cure Rate
  Time frame: 52 Weeks
  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

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Insights on Antifungal Therapy: Novel Nanotechnology Approaches for Drug Delivery Systems and New Drugs from Natural Sources.
   Sousa F, Ferreira D, Reis S, Costa P. · · 2020 · cited 80× · PMID 32942693 · DOI 10.3390/ph13090248
2. Topical and device-based treatments for fungal infections of the toenails.
   Foley K, Gupta AK, Versteeg S, Mays R, et al · · 2020 · cited 29× · PMID 31978269 · DOI 10.1002/14651858.cd012093.pub2
3. ONYCHOMYCOSIS: A Review of New and Emerging Topical and Device-based Treatments.
   Kawa N, Lee KC, Anderson RR, Garibyan L. · · 2019 · cited 9× · PMID 32038746