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Comparison of two topical preparations for the treatment of onychomycosis: Melaleuca alternifolia (tea tree) oil and clotrimazole
Abstract
The prevalence of onychomycosis, the most frequent cause of nail disease, ranges from 2% to 13%. Standard treatments include debridement, topical medications, and systemic therapies. This study assesses the efficacy and tolerability of topical application of 1% clotrimazole solution compared with that of 100% Melaleuca alternifolia (tea tree) oil for the treatment of toenail onychomycosis.
A double-blind, multicenter, randomized controlled trial was performed at two primary care health and residency training centers and one private podiatrist's office. The participants included 117 patients with distal subungual onychomycosis proven by culture. Patients received twice-daily application of either 1% clotrimazole (CL) solution or 100% tea tree (TT) oil for 6 months. Debridement and clinical assessment were performed at 0, 1, 3, and 6 months. Cultures were obtained at 0 and 6 months. Each patient's subjective assessment was also obtained 3 months after the conclusion of therapy.
The baseline characteristics of the treatment groups did not differ significantly. After 6 months of therapy, the two treatment groups were comparable based on culture cure (CL = 11%, TT = 18%) and clinical assessment documenting partial or full resolution (CL = 61%, TT = 60%). Three months later, about one half of each group reported continued improvement or resolution (CL = 55%; TT = 56%).
All current therapies have high recurrence rates. Oral therapy has the added disadvantages of high cost and potentially serious adverse effects. Topical therapy, including the two preparations presented in this paper, provide improvement in nail appearance and symptomatology. The use of a topical preparation in conjunction with debridement is an appropriate initial treatment strategy.
... Em relação ao tratamento das onicomicoses, estudos demonstraram a importância dos óleos essenciais (Buck et al., 1994;Abdelhamid et al., 2017;Alessandrini et al., 2020). Partindo da busca geral da literatura, a grande maioria dos dados apresentados até o momento utiliza como metodologia ensaios in vitro, como microdiluições em caldo e disco difusão, utilizando como base diversas cepas de agentes causadores de onicomicoses, como leveduras do gênero Candida, dermatófitos e fungos filamentosos não dermatófitos. ...
... Até o presente, não foram identificados estudos envolvendo modelo animal de onicomicose para avaliar ação antifúngica de óleos essenciais. Em se tratando de ensaios clínicos utilizando óleos essenciais para o tratamento das onicomicoses, foram identificados quatro estudos, três envolvendo o óleo essencial de melaleuca (Buck et al., 1994;Syed et al., 1999;Abdelhamid et al., 2017), e um utilizando três óleos essenciais: limão, orégano e melaleuca (Alessandrini et al., 2020). ...
... As quatro publicações avaliadas no presente estudo apresentaram resultados de cura dos pacientes após administração tópica do óleo essencial. Buck et al. (1994) e Abdelhamid et al. (2017) aplicaram o óleo de forma pura; Syed et al. (1999) administraram o óleo essencial em associação com butenafina a 2%; e Alessandrini et al. (2020) usaram o óleo composto (melaleuca, orégano e lima) em formulação patenteada. Merece destaque o fato de que, nesses estudos, os pacientes apresentaram cura das lesões, com boa recuperação e baixo índice de reações adversas, parâmetros que são muito importantes no desenvolvimento de formulações medicamentosas. ...
Resumo Esta pesquisa tem como objetivos identificar e reunir na literatura científica estudos que avaliam o uso de óleos essenciais em modelos de infecção ungueal ou em ensaios clínicos. Foram realizadas buscas em cinco bases de dados: PubMed, Scopus, Scielo, Embase e Google Acadêmico, sendo recuperadas 184 referências após a retirada de duplicatas, resultando em seis estudos, que foram selecionados e incluídos na síntese de análise qualitativa final. Os óleos essenciais de melaleuca, cravo, orégano e tomilho mostraram-se possíveis candidatos a novos antifúngicos, direcionados ao tratamento de onicomicoses, sendo o óleo de melaleuca o mais avaliado. No entanto, mais estudos são necessários para avaliar a eficácia e segurança desses óleos essenciais no tratamento de onicomicose.
... Six studies were published in the field of ophthalmology addressing Demodex infestation [n = 4; (Koo et al., 2012;Karakurt and Zeytun, 2018;Wong et al., 2019;Craig et al., 2022)], dry eye post cataract surgery [n = 1; (Mohammadpour et al., 2020)], or meibomian gland dysfunction [n = 1; (Zarei-Ghanavati et al., 2021)]. Three studies were published in the field of podiatry addressing onychomycosis [n = 1; (Buck et al., 1994)], or tinea pedis [n = 2; (Tong et al., 1992;Satchell et al., 2002b)]. Tables 1-6 summarize the characteristics of included studies i.e., country, setting, sample size and demographic profile, interventions, comparisons, and outcome measures, as well as results for efficacy and safety, according to the health problem studied e.g. ...
... Three trials were published in the field of podiatry from 1992 to 2002, and conducted in Australia (Tong et al., 1992; (Buck et al., 1994), within hospital or community outpatient clinics. ...
... One subject applying Tinaderm ® developed mild erythema (Tong et al., 1992). Buck et al. (1994), tested twice daily topical application of 100% tea tree oil, compared with a 1% clotrimazole antifungal solution, for 6 months for the treatment of onychomycosis-a fungal toenail infection (Buck et al., 1994). Tea tree oil was found to be as effective as the clotrimazole solution based on negative fungal culture at 6 months (i.e., post-intervention). ...
Introduction: Leaves of the Australian tea tree plant Melaleuca alternifolia were used traditionally by First Nations Australians for treating wounds, burns, and insect bites. Tea tree oil, the essential oil steam-distilled from M. alternifolia, is well-known for its medicinal properties, the evidence for most applications however is limited. This review aimed to critically appraise evidence from clinical trials examining the therapeutic efficacy and safety of tea tree oil on outcomes.
Methods: Randomized controlled trials with participants of any age, gender, or health status, comparing tea tree oil to any control were included, without limit on publication date. Electronic databases were searched on 12 August 2022 with additional records sourced from article reference sections, reviews, and industry white papers. Risk of bias was assessed by two authors independently using the Cochrane risk-of-bias 1.0 tool. Results were summarized and synthesized thematically.
Results: Forty-six articles were eligible from the following medical fields (Dentistry n = 18, Dermatology n = 9, Infectious disease n = 9, Ophthalmology n = 6, Podiatry n = 3; and Other n = 1). Results indicate that oral mouthwashes with 0.2%–0.5% tea tree oil may limit accumulation of dental plaque. Gels containing 5% tea tree oil applied directly to the periodontium may aid treatment of periodontitis as an adjunctive therapy to scaling and root planing. More evidence is needed to confirm the benefits of tea tree oil for reducing acne lesions and severity. Local anti-inflammatory effects on skin, if any, also require further elucidation. Topical tea tree oil regimens show similar efficacy to standard treatments for decolonizing the body from methicillin-resistant Staphylococcus aureus, although intra-nasal use of tea tree oil may cause irritation to mucous membranes. Tea tree oil with added iodine may provide an effective treatment for molluscum contagiosum lesions in young children. More evidence on efficacy of tea tree oil-based eyelid wipes for Demodex mite control are needed. Side effects were reported in 60% of included studies and were minor, except where tea tree oil was applied topically in concentrations ≥ 25%.
Discussion: Overall, the quality of research was poor to modest and higher quality trials with larger samples and better reporting are required to substantiate potential therapeutic applications of tea tree oil.
Systematic Review Registration: PROSPERO, identifier [CRD42021285168].
... In addition, it has been reported that Brazilian green propolis causes a clinical improvement in tinea pedis interdigitalis, tinea corporis [115], tinea capitis, and tinea versicolor [116]. Finally, other polyphenols such as Ocimum gratissimum [117], Acalypha wilkesiana [118], Cymbopogon citratus [119], Cassia alata [120], and Melaleuca alternifolia [121] have demonstrated improvement in fungal infections. ...
Although not frequently lethal, dermatological diseases represent a common cause of consultation worldwide. Due to the natural and non-invasive approach of phytotherapy, research for novel alternatives, such as polyphenols, to treat skin disorders is a subject of interest in modern medicine. Polyphenols, in particular, have been considered because of their anti-inflammatory, antitumoral, antimicrobial, and antioxidant properties, low molecular weight, and lipophilic nature that enables the passage of these compounds through the skin barrier. This review discusses the treatment of common dermatological diseases such as acne vulgaris, fungal infections, dermatitis, alopecia, and skin cancer, using polyphenols as therapeutic and prophylactic options. The specific molecules considered for each disorder, mechanisms of action, current clinical trials, and proposed applications are also reviewed.
... 55 Tea tree oil is effective against T rubrum, the most prevalent cause of onychomycosis, in in vitro antifungal assays. 56 Misner discovered that a blend of essential oils applied topically to the feet and containing tea tree oil blocked the growth of aerobic bacteria, yeast and fungus on the foot when enclosed in shoes. 57 Tea tree oil and clotrimazole are both used to treat onychomycosis, but Buck and coworkers compared how well they work. ...
Onychomycosis, commonly referred to as nail fungus, is a persistent
and difficult-to-treat condition that affects both toes and fingernails. Even
though traditional treatments such as antifungal medications and topical
ointments are effective in some cases, they are often associated with sig�nificant side effects and a high recurrence rate. There has been a growing
interest in alternative and complementary treatments in recent years, in�cluding natural remedies and new pharmaceutical formulations, which are
becoming increasingly popular. This review aims to explore the current
state of knowledge surrounding onychomycosis treatment and its chal�lenges, with a particular focus on the benefits and limitations of the current
therapeutic options. Also, light is shed on the prospects available as treat�ment options.
... The area from the point of insertion of the arrector pili muscle to the opening of the sebaceous gland duct comprises the middle segment of the follicle. The area between the follicular orifice and the sebaceous gland opening is known as the upper section of the follicle [2]. ...
In recent times, there has been a surge in the popularity of complementary as well as alternative therapies, like tea tree (melaleuca) oil. Now available everywhere as both a pure oil and an active ingredient in numerous products, this essential oil has been utilised for almost a century in Australia. In the past, the main applications of tea tree oil have been to treat infections and inflammations. This review outlines the latest advancements in our comprehension of the antibacterial, anti-inflammatory, and therapeutic effectiveness properties of the oil and its constituents. A brief discussion of the oil's toxicity is included, along with a description of the specific mechanisms of antibacterial as well as anti-inflammatory effect. Tea tree oil balances the scalp’s natural oil production, making its useful for combating oily hair. Its antifungal properties make it effective in fighting dandruff and dry scalp conditions. This essential oil can be mixed with carrier oils or added to your regular shampoo for easy use.Bottom of Form
... Tea tree oil may, with long-term use, be an effective treatment approach. In a double-blind, multicenter, randomized control trial involving 177 individuals with toenail onychomycosis, twice-daily application of 100% tea tree oil in conjunction with serial debridement was as effective as that of 1% clotrimazole solution with serial debridement, based on fungal culture results and clinical assessment after 6 months of treatment [12]. Around two-thirds of the patients in each study arm reported sustained or continued improvement of their symptoms 3 months after study completion. ...
The growing demand for natural treatments has raised concerns among clinicians due to limited scientific evidence supporting their use. This review article addresses the issue by assisting dermatologists and general practitioners in recommending natural treatments for the following common nail disorders: nail brittleness, onychomycosis, periungual verrucae, paronychia, chloronychia, nail psoriasis, nail lichen planus, onychocryptosis, onycholysis, and congenital malalignment of the great toenail. One limitation is the scarcity of existing reviews on natural treatment options for nail disorders in the literature. Through a comprehensive review of existing literature, this article consolidates the available evidence on natural treatment options for these conditions. Although some natural treatments for nail disorders are supported by scientific evidence, the indiscriminate use of such remedies may lead to severe poisoning and health problems. Given the widespread and increasing use of natural treatments, clinicians play a pivotal role in educating patients about evidence-based remedies and debunking misleading claims. By doing so, clinicians can enhance patient safety and improve treatment outcomes. It is essential for healthcare professionals to be well-informed and equipped with the knowledge to differentiate between effective natural treatments and unverified claims, ensuring that patients receive appropriate care.
... Investigations of the chemical composition of the essential oil of the stem of Myrcia alternifolia identified diverse terpenes, including arjunolic acid, and another oil constituents presents antifungal, antibacterial, antiviral, and analgesic properties (Buck et al., 1994;Hammer et al., 1996;Halcón & Milkus, 2004;Veras et al., 2019). This triterpene isolated has shown a relatively high antimicrobial activity (Moreira, 2010). ...
... All knowledge and practical skills were conveyed from one generation to another, but the chain of transition was cleaved at some point (Carson et al., 2019). At 1770's, Captain James Cook and his sailors named this tree as 'tea tree' due to its spicy smell (Ian Southwell, 1999 (Buck et al., 1994). ...
Melaleuca alternifolia (Maiden & Betche) Cheel oil (Tea Tree Oil, TTO) is an essential oil appropriate for medicinal and cosmetic usage. Tea tree oil is composed of complex formulation with more than 100 components; however, the most pharmaceutically active one is terpinen-4-ol. TTO can be implemented for decolonization of multi-resistant Staphylococcus aureus, anti-tumor therapy and antifungal activity based on different doses and exposure-duration proportionate with the targeted species. Antioxidant activity is related to α-terpinene, α-terpinolene and γ-terpinene. Hypersensitivity may occur as mild dermatitis or being aggravated to hepatitis and central nervous system reactions due to chronic or acute poisoning. Acne treatment prognosis shows significant improvement after TTO application proceeding by Propionibacterium acnes colony destruction. Plus, TTO usage psoriasis is also possible. Further investigations have premised TTO’s insecticidal effects performed by anticholinesterase activity. Destructive ability of the oil on Pityrosporum ovale is also indisputable and including TTO as the active ingredient has been highly beneficial for curing scalp dandruff. Expeditious antiviral activity is also considered as the promising characteristic suggested for this oil. Still, little information is available about feasibility of in vivo utilization.
... A multicentre RCT showed good clinical improvement in patients with distal subungual onychomycosis upon topical TTO for six months. It showed statistically significant improvement in appearance and symptoms of the disease (Buck et al. 1994). TTO has also been suggested to be active against the fungus Madueralla mycetomatis for the treatment of eumycetoma as it can easily penetrate through the skin (van de Sande et al. 2007). ...
Skin conditions causing discomfort are of common occurrence. Dermatology is a branch of western medicine dedicated to the study of skin complications which is complimented with medicine to provide symptomatic treatment. These skin disorders have also been mentioned in Ayurveda as the disease of 'Kustha' which is caused by the imbalances in tridoshas and dhatus (bodily elements). Ayurvedic texts describe the use of plant derived polyherbal medicines and other products of common use in an Indian kitchen with potential to provide relief and treat a variety of skin conditions. Despite their diverse uses, they are known to impart adverse effects and interfere with the metabolome of the cells. This chapter outlines different skin conditions and an integrated approach of western and Ayurvedic medicines to treat them, some plant derived products of common usage and their associated side effects.
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