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
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 analy...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2018-01-01
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| Series: | Journal of Dermatological Treatment |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/09546634.2017.1329510 |
| _version_ | 1797683726852816896 |
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| author | Aditya K. Gupta Steve Hall Lee T. Zane Shari R. Lipner Phoebe Rich |
| author_facet | Aditya K. Gupta Steve Hall Lee T. Zane Shari R. Lipner Phoebe Rich |
| author_sort | Aditya K. Gupta |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T00:20:00Z |
| format | Article |
| id | doaj.art-2ba58ebfafde4d138d451c24736a2631 |
| institution | Directory Open Access Journal |
| issn | 0954-6634 1471-1753 |
| language | English |
| last_indexed | 2024-03-12T00:20:00Z |
| publishDate | 2018-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Dermatological Treatment |
| spelling | doaj.art-2ba58ebfafde4d138d451c24736a26312023-09-15T14:08:30ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532018-01-01291444810.1080/09546634.2017.13295101329510Evaluation 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 studiesAditya K. Gupta0Steve Hall1Lee T. Zane2Shari R. Lipner3Phoebe Rich4University of TorontoSandoz Pharmaceuticals Inc.Anacor Pharmaceuticals Inc.Weill Cornell MedicineOregon Dermatology and ResearchPurpose: 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.http://dx.doi.org/10.1080/09546634.2017.1329510antifungal agentsan-2690long-term follow-uptavaboroletinea unguium |
| spellingShingle | Aditya K. Gupta Steve Hall Lee T. Zane Shari R. Lipner Phoebe Rich 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 Journal of Dermatological Treatment antifungal agents an-2690 long-term follow-up tavaborole tinea unguium |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | antifungal agents an-2690 long-term follow-up tavaborole tinea unguium |
| url | http://dx.doi.org/10.1080/09546634.2017.1329510 |
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