TABLE 5.

Summary of clinical studies using TTO

Study populationStudy typeTreatment groups (no. of evaluable patients)Administration of treatmentOutcomesAdverse eventsReference
124 patients with mild to moderate acneRCTa, investigator blindedb5% TTO gel (58), 5% benzoyl peroxide (61)3 moBoth significantly reduced inflamed lesions (P < 0.001) but BP better than TTO (P < 0.05); BP better at reducing oiliness (P < 0.02); less scaling (P < 0.02), pruritis (P < 0.05), dryness (P < 0.001) with TTO; treatments equivalent for noninflamed lesions, erythema27 (44%) in TTO group, 50 (79%) in BP group (e.g., dryness, stinging, burning, redness); significantly fewer events in TTO group (P < 0.001)14
18 patients with recurrent herpes labialis (cold sores)RCT, investigator blindedb6% TTO gel (9), placebo gel (9)5 times dailyMedian time to reepithelization of 9 days for TTO vs 12.5 days for placebo (not significant)1 in TTO group (event not stated)30
126 patients with mild to moderate dandruffRCT, investigator blindedb5% TTO shampoo (63), placebo shampoo (62)Daily for 4 wkWhole scalp lesion score significantly improved in TTO group (41.2%) compared to placebo group (11.2%) (P < 0.001)3 (5%) in TTO group, 8 (13%) in placebo group (e.g., mild burning, stinging, itching)130
30 hospital inpatients colonized or infected with MRSARandomized, controlled pilot study4% TTO nasal ointment + 5% TTO body wash (15), 2% mupirocin nasal ointment + Triclosan body wash (15)Frequency not stated, minimum of 3 daysFor TTO, 33% cleared, 20% chronic, 47% incomplete; for routine treatment, 3% cleared, 53% chronic, 33% incomplete (no significant differences)With TTO nasal ointment (no. not stated), mild swelling of nasal mucosa to acute burning28
236 hospital patients colonized with MRSARCT10% TTO cream + 5% TTO body wash (110), 2% mupirocin nasal ointment + 4% Triclosan body wash + 1% silver sulfadiazine cream (114)Once daily for 5 daysFor TTO, 41% cleared; for routine treatment, 49%cleared; treatment regimens did not differ significantly (P = 0.0286); mupirocin significantly better than TTO at clearing nasal carriage (P = 0.0001)None56
117 patients with culture-positive onychomycosisRCT, double blind100% TTO (64), 1% clotrimazole (53)Twice daily for 6 moFull or partial resolution for 60% of TTO and 61% of clotrimazole patients after 6 months of therapy (not significant; P > 0.05)5 (7.8%) in TTO group, 3 (5.7%) in clotrimazole group (erythema, irritation, edema)26
60 outpatients with a clinical diagnosis of onychomycosisRCT, double blind2% butenafine hydrochloride with 5% TTO cream (40), 5% TTO cream (20)3 times daily for 8 wkCure in 80% of butenafine/TTO group and 0% of TTO group (P < 0.0001)4 (10%) in butenafine/TTO group (mild inflammation)143
13 patients with AIDS and fluconazole-refractory oral candidiasisCase seriesMelaleuca oral solution (15 ml) (12)4 times daily for 2-4 wkClinical response rate of 67% after 4 weeks (cure in 2 patients, improvement in 6 patients, no response in 4 patients, 1 deterioration)None92
27 patients with AIDS and fluconazole-refractory oral candidiasisOpen-label trialMelaleuca oral solution (15 ml) (12), alcohol-free melaleuca oral solution (5 ml)c (13)4 times daily for 2-4 wkMycological and clinical response in 58% (alcohol-based solution) and 54% (alcohol-free solution) of patients after 4 wk8 (66.7%) in alcohol-based solution group, 2 (15.4%) in alcohol-free solution group (mild to moderate burning)149
121 patients with clinically diagnosed tinea pedisRCT, double blind10% TTO in sorbolene (37), 1% tolnaftate (33), placebo (sorbolene) (34)Twice daily for 4 wkMycological cure and clinical improvement in 46% (tolnaftate), 22% (TTO), and 9% (placebo) of patients; tolnaftate significantly better than placebo (P = 0.003) but not TTO (P = 0.59); TTO not different from placebo (P = 0.3)None145
137 patients with culture-positive tinea pedisRCT, double blind25% TTO (36), 50% TTO (38), placebo (46)Twice daily for 4 wkEffective cure in 48% (25% TTO), 50% (50% TTO), and 13% (placebo) of patients; TTO significantly better than placebo (P < 0.0005)1 (2.8%) in 25% TTO group, 3 (7.9%) in 50% TTO group (moderate to severe dermatitis)131
  • a RCT, randomized controlled trial.

  • b The distinctive odor of TTO was stated as preventing patient blinding.

  • c The alcohol-free solution was more concentrated, and thus a smaller volume was used.