Efficacy of Topical Antifungal Nail Solution Versus Topical Placebo Solution for the Treatment of Pedal Onychomycosis: A Randomized Controlled Trial
Abstract Introduction Pedal onychomycosis is common, and its treatment entails debridement combined with topical and/or oral antifungal medication. Methods In this study, 69 participants were randomly allocated to either active (31 [44.93%]) or placebo (38 [55.07%]) topical solution. The primary out...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Adis, Springer Healthcare
2025-05-01
|
| Series: | Infectious Diseases and Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/s40121-025-01165-8 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849234892925173760 |
|---|---|
| author | Donald Scot Malay Hye Rin Kim Nicholas John Perfetti Yolanda R. Marshall Peter J. Bregman Allysa M. Vavra |
| author_facet | Donald Scot Malay Hye Rin Kim Nicholas John Perfetti Yolanda R. Marshall Peter J. Bregman Allysa M. Vavra |
| author_sort | Donald Scot Malay |
| collection | DOAJ |
| description | Abstract Introduction Pedal onychomycosis is common, and its treatment entails debridement combined with topical and/or oral antifungal medication. Methods In this study, 69 participants were randomly allocated to either active (31 [44.93%]) or placebo (38 [55.07%]) topical solution. The primary outcome was mycological cure, and secondary outcomes included visible nail plate involvement and toenail-related quality of life. Results After a minimum duration of follow-up of 7 months and a maximum of 9 months, participants in the active solution group experienced statistically significantly greater mycological cure (1 [2.63%] placebo versus 17 [54.84%] active, p < 0.0001) and clinical cure (2 [5.56%] placebo versus 21 [70%] active, p < 0.0001), including 47.62% of which showed complete clearance of visible nail plate involvement with no residual gross nail plate dystrophy and improved toenail-related quality of life, including less symptom bothersomeness (p < 0.0344), less overall toenail problems (p < 0.0315), and greater satisfaction with treatment (p < 0.0195) as early as the 3-month follow-up visit. In addition, the active solution group experienced less frequent symptoms (p = 0.0046 at 9 months) and symptom bothersomeness (p = 0.0002 at 7 months, < 0.0001 at 9 months), less difficulty caring for toenails and better toenail appearance (p = 0.0250 at 7 months, p= 0.007 at 9 months), improved physical activity and less toenail pain (p = 0.0208 at 7 months, p = 0.003 at 9 months), less overall toenail problems (p = 0.0002 at 7 months, p = 0.0006 at 9 months), and greater treatment satisfaction (p = 0.0003 at 7 months, p = 0.0015 at 9 months). Conclusions Participants with pedal onychomycosis that were randomized to the active topical solution showed statistically significantly greater mycological and clinical cures, as well as improved quality of life, in comparison with those allocated to the placebo topical solution. Trial Registration ISRCTN Protocol no. 77852934. |
| format | Article |
| id | doaj-art-0f3ebbfcab8f4167b8226bd9efe3cbee |
| institution | Kabale University |
| issn | 2193-8229 2193-6382 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Infectious Diseases and Therapy |
| spelling | doaj-art-0f3ebbfcab8f4167b8226bd9efe3cbee2025-08-20T04:03:00ZengAdis, Springer HealthcareInfectious Diseases and Therapy2193-82292193-63822025-05-011471439145910.1007/s40121-025-01165-8Efficacy of Topical Antifungal Nail Solution Versus Topical Placebo Solution for the Treatment of Pedal Onychomycosis: A Randomized Controlled TrialDonald Scot Malay0Hye Rin Kim1Nicholas John Perfetti2Yolanda R. Marshall3Peter J. Bregman4Allysa M. Vavra5Staff Surgeon and Director of Podiatric Research, Penn Presbyterian Medical Center, Penn Podiatry University CityStaff Surgeon, Penn Presbyterian Medical Center, Penn Podiatry University CityPodiatric Research Fellow, Penn Presbyterian Medical Center, Penn Podiatry University CityPodiatric Research Fellow, Penn Presbyterian Medical Center, Penn Podiatry University CityFoot & Ankle Specialists of NevadaPodiatric Surgery Resident, Penn Presbyterian Medical CenterAbstract Introduction Pedal onychomycosis is common, and its treatment entails debridement combined with topical and/or oral antifungal medication. Methods In this study, 69 participants were randomly allocated to either active (31 [44.93%]) or placebo (38 [55.07%]) topical solution. The primary outcome was mycological cure, and secondary outcomes included visible nail plate involvement and toenail-related quality of life. Results After a minimum duration of follow-up of 7 months and a maximum of 9 months, participants in the active solution group experienced statistically significantly greater mycological cure (1 [2.63%] placebo versus 17 [54.84%] active, p < 0.0001) and clinical cure (2 [5.56%] placebo versus 21 [70%] active, p < 0.0001), including 47.62% of which showed complete clearance of visible nail plate involvement with no residual gross nail plate dystrophy and improved toenail-related quality of life, including less symptom bothersomeness (p < 0.0344), less overall toenail problems (p < 0.0315), and greater satisfaction with treatment (p < 0.0195) as early as the 3-month follow-up visit. In addition, the active solution group experienced less frequent symptoms (p = 0.0046 at 9 months) and symptom bothersomeness (p = 0.0002 at 7 months, < 0.0001 at 9 months), less difficulty caring for toenails and better toenail appearance (p = 0.0250 at 7 months, p= 0.007 at 9 months), improved physical activity and less toenail pain (p = 0.0208 at 7 months, p = 0.003 at 9 months), less overall toenail problems (p = 0.0002 at 7 months, p = 0.0006 at 9 months), and greater treatment satisfaction (p = 0.0003 at 7 months, p = 0.0015 at 9 months). Conclusions Participants with pedal onychomycosis that were randomized to the active topical solution showed statistically significantly greater mycological and clinical cures, as well as improved quality of life, in comparison with those allocated to the placebo topical solution. Trial Registration ISRCTN Protocol no. 77852934.https://doi.org/10.1007/s40121-025-01165-8DermatophyteOnyCOE-t™PAS stainQuality of lifeTolcylen®Tolnaftate |
| spellingShingle | Donald Scot Malay Hye Rin Kim Nicholas John Perfetti Yolanda R. Marshall Peter J. Bregman Allysa M. Vavra Efficacy of Topical Antifungal Nail Solution Versus Topical Placebo Solution for the Treatment of Pedal Onychomycosis: A Randomized Controlled Trial Infectious Diseases and Therapy Dermatophyte OnyCOE-t™ PAS stain Quality of life Tolcylen® Tolnaftate |
| title | Efficacy of Topical Antifungal Nail Solution Versus Topical Placebo Solution for the Treatment of Pedal Onychomycosis: A Randomized Controlled Trial |
| title_full | Efficacy of Topical Antifungal Nail Solution Versus Topical Placebo Solution for the Treatment of Pedal Onychomycosis: A Randomized Controlled Trial |
| title_fullStr | Efficacy of Topical Antifungal Nail Solution Versus Topical Placebo Solution for the Treatment of Pedal Onychomycosis: A Randomized Controlled Trial |
| title_full_unstemmed | Efficacy of Topical Antifungal Nail Solution Versus Topical Placebo Solution for the Treatment of Pedal Onychomycosis: A Randomized Controlled Trial |
| title_short | Efficacy of Topical Antifungal Nail Solution Versus Topical Placebo Solution for the Treatment of Pedal Onychomycosis: A Randomized Controlled Trial |
| title_sort | efficacy of topical antifungal nail solution versus topical placebo solution for the treatment of pedal onychomycosis a randomized controlled trial |
| topic | Dermatophyte OnyCOE-t™ PAS stain Quality of life Tolcylen® Tolnaftate |
| url | https://doi.org/10.1007/s40121-025-01165-8 |
| work_keys_str_mv | AT donaldscotmalay efficacyoftopicalantifungalnailsolutionversustopicalplacebosolutionforthetreatmentofpedalonychomycosisarandomizedcontrolledtrial AT hyerinkim efficacyoftopicalantifungalnailsolutionversustopicalplacebosolutionforthetreatmentofpedalonychomycosisarandomizedcontrolledtrial AT nicholasjohnperfetti efficacyoftopicalantifungalnailsolutionversustopicalplacebosolutionforthetreatmentofpedalonychomycosisarandomizedcontrolledtrial AT yolandarmarshall efficacyoftopicalantifungalnailsolutionversustopicalplacebosolutionforthetreatmentofpedalonychomycosisarandomizedcontrolledtrial AT peterjbregman efficacyoftopicalantifungalnailsolutionversustopicalplacebosolutionforthetreatmentofpedalonychomycosisarandomizedcontrolledtrial AT allysamvavra efficacyoftopicalantifungalnailsolutionversustopicalplacebosolutionforthetreatmentofpedalonychomycosisarandomizedcontrolledtrial |