Australas J. Dermatol 1992; 33: 145-149

TEA TREE OIL IN THE TREATMENT OF TINEA PEDIS MELINDA M . TONG, PHILLIP M . ALTMAN AND ROSS StC. BARNETSON

Sydney SUMMARY

Tea tree oil (an essential oil derived primarily from the Australian native Melaleuca alternifolia^ has been used as a topical antiseptic agent since the early part of this century for a wide variety of skin infections; however, to date, the evidence for its efficacy in fungal infections is still largely anecdotal. One hundred and four patients completed a randomized, double-blind trial to evaluate the efficacy of 10% w/w tea tree oil cream compared with 1% tolnaftate and placebo creams in the treatment of tinea pedia. Significantly more tolnaftate-treated patients (85%) than tea tree oil (30%) and placebo-treated patients (21%) showed conversion to negative culture at the end of therapy (p^O.OOl); there was no statistically significant difference between tea tree oil and placebo groups. All three groups demonstrated improvement in clinical condition based on the four clinical parameters of scaling, inflammation, itching and burning. The tea tree oil group (24/37) and the tolnaftate group (19/33) showed significant improvement in clinical condition when compared to the placebo group (14/34; p = 0.022 and p = 0.018 respectively). Tea tree oil cream (10% w/w) appears to reduce the symptomatology of tinea pedis as effectively as tolnaftate 1% but is no more effective than placebo in achieving a mycological cure. This may be the basis for the popular use of tea tree oil in the treatment of tinea pedis. Key words; Tea tree oil, tinea pedis. tion with Candida or gram negative organisms."* Skin scrapings should be taken for microscopy and fungal culture to establish the diagnosis of Tinea pedis is the commonest form of superficial dermatophyte infection in the tinea pedis. Topical and oral antifungals are used developed world, affecting at any one time as for eradication of the infection, but control of many as 10% of the total population.' It was first hyperhidrosis, good hygiene, and nonocclusive described by Pellizari in 1882,^ and it was footwear are also important. The most commonly probably uncommon until humans began wearing used agent for treatment of tinea pedis in occlusive footwear.' Infection is common during Australia is tolnaftate {Tinaderm® )': it is summer months, especially when hyperhidrosis efficacious with minimal side effects and is is an underlying problem." Men are more com- available as a cream, lotion, spray or powder. monly afflicted than women. The infection is Tea tree oil is an essential oil extracted primarily most commonly caused by the related fungi from the leaves of Melaleuca alternifolia, an Trichophyton rubrum, Trichophyton Australian native. It has been used as a germicidal mentagrophytes and Epidermophyton agent since the early twentieth century^ for a wide floccosum.' Tinea pedis can often be clinically variety of ailments such as wound infections and indistinguishable from infec- bacterial and fungal infections of the skin and oral mucosa." The evidence for the efficacy of Melinda M. Tong, MB, BS(Hons). Dermatology Resident. tea tree oil in fungal infections has been largely Ross StC. Barnetson, MD, FRACP, FACD. Professor of anecdotal, and no published data could be found Dermatology. comparing the efficacy of Australian tea tree oil Dermatology Department, Royal Prince Alfred Hospital. Phillip M. Altman, B.Pharm(Hons), MSc, PhD. Managing with an established mode of treatment of tinea Director, Pharmaco Pty Ltd, 15/303 Pacific Hwy, Lindfield, pedis. The aim of this study is to compare the NSW 2070. efficacy of 10%w/w tea tree oil cream with 1% Address for correspondence: Professor R. StC. Barnetson, tolnaftate and placebo creams in the treatment Department of Dermatology, Royal Prince Alfred Hospital, of tinea pedis. Camperdown, NSW 2050. TEA TREE OIL IN THE TREATMENT OF TINEA PEDIS

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MELINDA M . TONG, PHILLIP M . ALTMAN AND ROSS StC. BARNETSON

At each visit, the following signs and symptoms were scored on a scale of 0 to 4 (0 = absent, One hundred and twenty one patients were enrolled in the study and 104 completed it. l=mild, 2 = moderate, 3 = severe, 4 = very severe): Patients were between the ages of 16 and 65 years scaling, inflammation, itching and burning. The with tinea pedis diagnosed clinically (interdigital, total sum of severity scores was calculated for moccasin, vesicular and verrucous manifesta- each visit. At the end of therapy a skin scraping tions) and by positive fungal culture. Patients were was taken for microscopy and culture and clinical excluded if they had received systemic antifungal evaluation was made of each patient's response. drugs in the preceding six months or topical The difference between visit 4 and visit 1 in the antifungal therapy in the preceding week. Patients total severity scores was classified as follows: were also excluded if they had any medical con- 1) improvement by more than 2 points; ditions or were taking any medications that would 2) improvement by 2 or less points or deteriorapredispose them to fungal infections, e.g. diabetes tion. The overall efficacy of treatment based on mellitus, corticosteroid therapy. All patients with the combination of clinical and mycological positive microscopy findings (potassium responses was classified as follows: 1) mycological hydroxide preparation) were removed from the cure (negative culture) and improvement in study after treatment had started if the culture severity score (^2 points); 2) mycological cure for dermatophytes, which takes 2-4 weeks, was and no improvement in severity score; 3) no negative (delayed exclusion). Patients who were mycological cure and improvement in severity initially excluded because of a negative micro- score, and 4) no mycological cure and no scopy finding were subsequently enrolled in the improvement in severity score. Effective treatment study if culture was positive, provided they did or "complete cure" was defined as mycological not institute any other form of treatment in the cure with clinical improvement. Therapy was interim and the clinical condition of the infection rated as ineffective in all other cases, even if signs had not changed significantly (delayed inclusion). and symptoms had improved. Statistical analysis: To test for differences in At entry all patients had either a positive clinical response between two treatment groups microscopy result (KOH preparation) or positive the chi-squared test and Fisher's exact test for culture result. In a double-blind manner, patients matched samples were used. All test results were were randomly assigned to apply one of three deemed significant if p-^0.05. creams twice daily for four weeks. The creams RESULTS were: 1) tolnaftate 1% cream (commercially One hundred and twenty one patients were available Tinaderm® cream manufactured by Schering Pty Ltd, Sydney, Australia); 2) tea tree entered in the study. Fifteen patients had negative oil 10% w/w in sorbolene cream (the formula- initial cultures for dermatophytes and were theretion was developed by Pharmaco Pty Ltd, Sydney, fore classified as delayed exclusions (4 tolnaftateAustralia); and 3) vehicle cream (sorbolene cream) treated, 5 tea tree oil-treated, and 8 placebowhich was the placebo. The selection of a four treated). One patient who failed to attend the last week treatment period was based on standard clinical visit was dropped from the study (tea tree therapy for tinea pedis with most currently avail- oil group). Another patient who had used other able topical antifungals. Patients were seen four antifungal medication concurrently was dropped times over a period of 5 weeks. For those patients from the study (sorbolene group). Sixteen patients whose microscopy was negative but culture was who initially had negative microscopy findings positive the interval between the first visit when but who subsequently had positive culture results the scraping was taken and the second visit when were enrolled (delayed inclusion). The total the cream was issued varied depending on how number of evaluable patients was 104: 33 were in long it took to confirm the culture; the rest of the tolnaftate group, 37 in the tea tree oil group, the visits were undertaken over one month, the and 34 in the placebo group. No patient in the same as for the other patients. Patients were study had to discontinue due to adverse effects. Demographic data for the study group are removed from the study if they missed visits or did not comply in any way with the study shown in Table 1. Seventy nine patients (76%) protocol. They could also be discontinued from were male. The distribution of male and female the study if they experienced severe adverse events. in each group was uneven: 97% of the patients METHOD

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TEA TREE OIL IN THE TREATMENT OF TINEA PEDIS

TABLE 1

TABLE 2

Demographic Patient Data Placebo Tea tree oil Tolnaftate All No. of patients — males — females Age (years) — median — range

34 33 1

37 24 13

33 22 II

104 79 25

34 19-65

30 18-60

30 20-57

31 19-65

34

31

97

6 1-40

10 1-24

6 1-40

17 17

18 12

49 41

3 37

3 33

41 104

No. of patients with recurrent tinea 32 Duration (weeks) — median 6 — range 1-28 Infecting organism — T. rubrum 14 — T. mentagrophytes 12 — E. floccosum + others -8 — Total 34

Overall evaluation of clinical-mycological response Improvement in Number of patients Mycological total severity cure?

Tea tree oil in the treatment of tinea pedis.

Tea tree oil (an essential oil derived primarily from the Australian native Melaleuca alternifolia) has been used as a topical antiseptic agent since ...
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