Evaluation of the efficacy and safety of tavaborole topical solution, 5%, in the treatment of onychomycosis of the toenail in adults

a pooled analysis of an 8-week, post-study follow-up from two randomized phase 3 studies

Aditya K. Gupta, Steve Hall, Lee T. Zane, Shari R. Lipner, Phoebe Rich

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Purpose: The role of topical antifungal agents in the long-term management of toenail onychomycosis is not well established. The current study evaluated durability of clinical benefit of tavaborole topical solution, 5%, for the treatment of toenail onychomycosis. Methods: We conducted a pooled analysis of 8-week, post-study follow-up (PSFU) data from two phase 3, randomized controlled trials in a subset of patients who experienced complete or almost clear nail (CN) at the end of treatment (week 52); 48 weeks of treatment with once-daily tavaborole compared with placebo in adults with distal subungual onychomycosis was evaluated at week 60. Complete cure (completely CN plus negative mycology) of the target great toenail and treatment success (<10% nail involvement plus negative mycology) were evaluated at week 52 versus week 60. Results: Of the 62 patients who completed the PSFU, complete cure was higher in the tavaborole-treated group versus the vehicle control group (28.6% vs. 7.7%). Additionally, treatment success was 53.1% for the tavaborole group versus 23.1% in the vehicle group. Small sample size entering the PSFU limited robust statistical analysis. Conclusion: Tavaborole topical solution, 5%, appears to provide durable clinical benefit, making it an attractive long-term treatment option for dermatophyte-associated onychomycosis of the toenail.

Original languageEnglish (US)
Pages (from-to)44-48
Number of pages5
JournalJournal of Dermatological Treatment
Volume29
Issue number1
DOIs
StatePublished - Jan 2 2018
Externally publishedYes

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Onychomycosis
Nails
Safety
Mycology
Therapeutics
Arthrodermataceae
Antifungal Agents
tavaborole
Sample Size
Randomized Controlled Trials
Placebos
Control Groups

Keywords

  • AN-2690
  • Antifungal agents
  • long-term follow-up
  • tavaborole
  • tinea unguium

ASJC Scopus subject areas

  • Dermatology

Cite this

@article{882a4d47ed39417181b19f3652b05b01,
title = "Evaluation of the efficacy and safety of tavaborole topical solution, 5{\%}, in the treatment of onychomycosis of the toenail in adults: a pooled analysis of an 8-week, post-study follow-up from two randomized phase 3 studies",
abstract = "Purpose: The role of topical antifungal agents in the long-term management of toenail onychomycosis is not well established. The current study evaluated durability of clinical benefit of tavaborole topical solution, 5{\%}, for the treatment of toenail onychomycosis. Methods: We conducted a pooled analysis of 8-week, post-study follow-up (PSFU) data from two phase 3, randomized controlled trials in a subset of patients who experienced complete or almost clear nail (CN) at the end of treatment (week 52); 48 weeks of treatment with once-daily tavaborole compared with placebo in adults with distal subungual onychomycosis was evaluated at week 60. Complete cure (completely CN plus negative mycology) of the target great toenail and treatment success (<10{\%} nail involvement plus negative mycology) were evaluated at week 52 versus week 60. Results: Of the 62 patients who completed the PSFU, complete cure was higher in the tavaborole-treated group versus the vehicle control group (28.6{\%} vs. 7.7{\%}). Additionally, treatment success was 53.1{\%} for the tavaborole group versus 23.1{\%} in the vehicle group. Small sample size entering the PSFU limited robust statistical analysis. Conclusion: Tavaborole topical solution, 5{\%}, appears to provide durable clinical benefit, making it an attractive long-term treatment option for dermatophyte-associated onychomycosis of the toenail.",
keywords = "AN-2690, Antifungal agents, long-term follow-up, tavaborole, tinea unguium",
author = "Gupta, {Aditya K.} and Steve Hall and Zane, {Lee T.} and Lipner, {Shari R.} and Phoebe Rich",
year = "2018",
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doi = "10.1080/09546634.2017.1329510",
language = "English (US)",
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journal = "Journal of Dermatological Treatment",
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T1 - Evaluation of the efficacy and safety of tavaborole topical solution, 5%, in the treatment of onychomycosis of the toenail in adults

T2 - a pooled analysis of an 8-week, post-study follow-up from two randomized phase 3 studies

AU - Gupta, Aditya K.

AU - Hall, Steve

AU - Zane, Lee T.

AU - Lipner, Shari R.

AU - Rich, Phoebe

PY - 2018/1/2

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N2 - Purpose: The role of topical antifungal agents in the long-term management of toenail onychomycosis is not well established. The current study evaluated durability of clinical benefit of tavaborole topical solution, 5%, for the treatment of toenail onychomycosis. Methods: We conducted a pooled analysis of 8-week, post-study follow-up (PSFU) data from two phase 3, randomized controlled trials in a subset of patients who experienced complete or almost clear nail (CN) at the end of treatment (week 52); 48 weeks of treatment with once-daily tavaborole compared with placebo in adults with distal subungual onychomycosis was evaluated at week 60. Complete cure (completely CN plus negative mycology) of the target great toenail and treatment success (<10% nail involvement plus negative mycology) were evaluated at week 52 versus week 60. Results: Of the 62 patients who completed the PSFU, complete cure was higher in the tavaborole-treated group versus the vehicle control group (28.6% vs. 7.7%). Additionally, treatment success was 53.1% for the tavaborole group versus 23.1% in the vehicle group. Small sample size entering the PSFU limited robust statistical analysis. Conclusion: Tavaborole topical solution, 5%, appears to provide durable clinical benefit, making it an attractive long-term treatment option for dermatophyte-associated onychomycosis of the toenail.

AB - Purpose: The role of topical antifungal agents in the long-term management of toenail onychomycosis is not well established. The current study evaluated durability of clinical benefit of tavaborole topical solution, 5%, for the treatment of toenail onychomycosis. Methods: We conducted a pooled analysis of 8-week, post-study follow-up (PSFU) data from two phase 3, randomized controlled trials in a subset of patients who experienced complete or almost clear nail (CN) at the end of treatment (week 52); 48 weeks of treatment with once-daily tavaborole compared with placebo in adults with distal subungual onychomycosis was evaluated at week 60. Complete cure (completely CN plus negative mycology) of the target great toenail and treatment success (<10% nail involvement plus negative mycology) were evaluated at week 52 versus week 60. Results: Of the 62 patients who completed the PSFU, complete cure was higher in the tavaborole-treated group versus the vehicle control group (28.6% vs. 7.7%). Additionally, treatment success was 53.1% for the tavaborole group versus 23.1% in the vehicle group. Small sample size entering the PSFU limited robust statistical analysis. Conclusion: Tavaborole topical solution, 5%, appears to provide durable clinical benefit, making it an attractive long-term treatment option for dermatophyte-associated onychomycosis of the toenail.

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