BUTENAFINE HYDROCHLORIDE AND MELALEUCA ALTERNIFOLIA OIL COMBINATION IN TREATMENT OF TOENAIL ONYCHOMYCOSIS: A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY.
DOI:
https://doi.org/10.48047/kamzrb58Keywords:
Onychomycosis, butenafine hydrochloride, Melaleuca alternifolia oil,, toenail fungus, topical treatment, antifungal therapy, dermatophytes, clinical efficacy, placebo-controlled trial.Abstract
A fungus infection of the toenails (onychomycosis) is a common pathological condition and it is extremely difficult to both diagnose and cure. This was a study that examined the safety and clinical effectiveness of 2 percent butenafine hydrochloride combined with 5 percent Melaleuca alternifolia oil in topical cream treatment of toenail onychomycosis. One hundred and twenty-five patients, aged 18-80 and with at least 25 % involvement of one of their toenails with fungus were recruited in a randomized, placebo-controlled study. Right in the active cream group (n=60), think 80 percent of cure rate and when crossing the sexes, 83.3 percent male and 75 percent female achieved clinical success. None of the patients on placebo became cured. Only a few side effects were noticed including swelling in 6.7 % of patients and hardly any side effect was reported at all. There were no relapses in one-year follow up. The active treatment group showed to penetrate and stay more in the body using the antifungal agents than other systemic treatments that tend to have serious side effects, the treatments need to be on long term regimens and are generally prone to failing in time. This multimodal therapy had a more safer and effective and accelerated option instead of the systemic antifungal therapies, thus substantiating the possibility of topical therapy in treating onychomycosis without the supplement of systemic medications.
Downloads
References
Amichai, B., & Grunwald, M. H. (1998). Adverse drug reactions of the new oral antifungal treatments – terbinafine, fluconazole, and itraconazole. International Journal of Dermatology, 37(5), 410-415.
Baran, R. L., & Aly, R. (1997). Diagnosis and new treatments in the management of onychomycosis. In R. Aly, K. R. Beutner, & H. I. Maibach (Eds.), Cutaneous Infection and Therapy (pp. 149-152). Marcel Dekker, New York.
Brennan, B., & Leyden, J. J. (1997). Overview of topical therapy for common superficial fungal infections and the role of new topical agents. Journal of the American Academy of Dermatology, 36(6), S3-S8.
Buck, D. S., Nidorf, D. M., & Addino, J. G. (1994). Comparison of two topical preparations for the treatment of onychomycosis: Melaleuca alternifolia (tea tree) oil and clotrimazole. Journal of Family Practice, 38(6), 601-605.
Crissey, J. T., Heidi, L., & Parish, L. C. (1995). Therapeutic agents. In Manual of Medical Mycology (pp. 19-35). Blackwell Science, Oxford.
Drake, L. A., Shear, N. H., Arlette, J., et al. (1997). Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial. Journal of the American Academy of Dermatology, 37(5), 740-745.
Friedman-Birnbaum, R., Coghen, A., Shemar, et al. (1997). Treatment of onychomycosis: A randomized, double-blind comparison study with topical bifonazole-urea ointment alone and in combination with short-duration oral griseofulvin. International Journal of Dermatology, 36(2), 67-69.
Fukushiro, R., Urabe, H., Kagawa, et al. (1992). Butenafine hydrochloride, a new antifungal agent, clinical and experimental study. In H. Yamaguchi, G. S. Kobayashi, & H. Takahashi (Eds.), Recent Progress in Antifungal Chemotherapy (pp. 147-157). Marcel Dekker, New York.
Gupta, A. K., Sibbald, R. G., Lynde, C., et al. (1997). Onychomycosis in children: Prevalence and treatment strategies. Journal of the American Academy of Dermatology, 36(3), 395-402.
Haneke, E. (1990). Epidemiology and pathology. In S. Nolting & H. C. Korting (Eds.), Onychomycoses (pp. 1-5). Springer, Heidelberg.
Rashid, A., & Richardson, M. D. (1997). Pathogenesis of dermatophytosis. In R. Aly, K. R. Beutner, & H. I. Maibach (Eds.), Cutaneous Infection and Therapy (pp. 127-138). Marcel Dekker, New York.
Roberts, D. T. (1994). Oral therapeutic agents in fungal nail disease. Journal of the American Academy of Dermatology, 31(3), S78-S81.
Summerbell, R. C. (1997). Epidemiology and ecology of onychomycosis. Dermatology, 194(1), S32-S36.
Syed, T. A., Ahmadpur, O. A., Ahmad, S. A., & Shamsi, S. (1998). Management of Toenail Onychomycosis with 2% Butenafine and 20% Urea Cream: A Placebo-Controlled, Double-Blind Study. Journal of Dermatology, 25(11), 701-704.
Torres-Rodriguez, J. M., Madreny, N., & Nicolas, M. C. (1991). Non-traumatic topical treatment of onychomycosis with urea associated with bifonazole. Mycoses, 34(8), 499-504.
Tschen, E., Elewski, B., Gosulowsky, D. C., & Pariser, D. M. (1997). Treatment of interdigital tinea pedis with a 4-week once-daily regimen of butenafine hydrochloride 1% cream. Journal of the American Academy of Dermatology, 36(1), S9-S14.
Walker, M. (1962). A successful antifungal regime. Current Podiatry, 2(1), 7-15.
Downloads
Published
Issue
Section
License

This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format for any purpose, even commercially.
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
- The licensor cannot revoke these freedoms as long as you follow the license terms.
Under the following terms:
- Attribution — You must give appropriate credit , provide a link to the license, and indicate if changes were made . You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
Notices:
You do not have to comply with the license for elements of the material in the public domain or where your use is permitted by an applicable exception or limitation .
No warranties are given. The license may not give you all of the permissions necessary for your intended use. For example, other rights such as publicity, privacy, or moral rights may limit how you use the material.
