Oromucosal use or cutaneous use
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- Table 2: Traditional use of tea tree oil Reference Documented Use / Traditional Use Herbal preparation
- 2.2. Information on traditional/current indications and specified substances/preparations
- 2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications
- Table 3: Information on preparations of TTO grouped according to the traditional use Herbal preparation Pharmaceutical form Indication
- Herbal preparation Pharmaceutical form Indication Strength Posology Period of medicinal use
2. Historical data on medicinal use 2.1. Information on period of medicinal use in the Community Melaleuca alternifolia oil has been used as medicinal by Australian Bundjabung Aborigines for several millennia for bruises, insect bites, and skin infections. European colonists soon recognized the therapeutic properties and began to distil oil from its leaves (Carson & Riley 2001). Members of the crew of James Cook described at the end of the eighteenth century the use of the TTO. It was rediscovered in the 1920s as a topical antiseptic with more effective activity than phenol (Bozzuto et
The essential oil was distilled for the first time in 1925 and due to its antiseptic, antibacterial and antifungal effects became a standard antiseptic agent for surgery, especially for dental surgery (Saller
The monograph on TTO of the British Pharmaceutical Codex of 1949 reports that TTO has germicidal properties and has been used as a local application in the treatment of furunculosis, tinea, paronychia, impetigo, trush and stomatitis, and as inhalant in coryza. In veterinary practice it has been used in the treatment of mange and eczema and in sores and skin diseases of parasitic origin. TTO has been used for its bactericidal and fungicidal properties as a disinfectant component in several medicinal combination products with non-herbal ingredients authorised in UK since before 1970.
Assessment report on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum
EMA/HMPC/320932/2012 Page 8/73
A cutaneous liquid containing TTO has been authorised in Denmark from 1993 to 2009 for disinfection in acne and in fungal infections on the foot. In Sweden a cutaneous liquid is marketed since 1988 and a oromucosal and cutaneous solution is registered in Hungary since 2004. Table 2 shows a consistent and long standing use of TTO demonstrated for more than 30 years, since 1930, internationally and for more than 15 years, since 1933, in the European Community. A wide range of traditional indications have been described for local application including the nasal, mouth and throat regions. TTO has been used as an antiseptic for special and general dental surgery and in denture and mouth washes (MacDonald 1930, Anonymous 1933, Penfold & Morrison 1937, Penfold & Morrison 1950). It has also been indicated for a variety of skin conditions including bacterial and fungal infections of the skin such as acne, furunculosis, dermatophytosis (tinea pedis, tinea cruris, tinea barbae), pityriasis versicolor (tinea versicolor), parionychia, impetigo, empyema, dermatitis, eczema, psoriasis, skin rashes, impetigo contagiosa, pediculosis, ringworm, thrush, infected pustules, intertrigo and nail infections (caused by Candida albicans), parasitic skin diseases (Penfold & Morrison 1937, Penfold & Morrison 1950, Humphery 1930, Martindale 1993, British Pharmaceutical Codex 1949, Walker 1972, WHO 2004). Many different foot problems have been treated by TTO including onychomycosis infections of toenails, bromidrosis, malodour, cracks, fissures, peeling, callused heels, inflammation of corns, calluses, bunions, hammertoes, post-operative wound healing (Walker 1972, WHO 2004). It has also been used for the treatment of infected, colonised, dirty wounds, diabetic gangrene and chronic leg ulcers, burns and wounds (Penfold & Morrison 1937, Penfold & Morrison 1950, Humphery 1930, WHO 2004). Throat, nasal and mouth conditions including acute nasopharyngitis, catarrh, thrush, stomatitis, tonsillitis, mouth ulcers, sore throat, coughs and colds, nasopharyngitis, sinus congestion, tonsillitis, pyorrhoea, gingivitis are traditional indications for use of TTO (Penfold & Morrison 1937, Penfold & Morrison 1950, Humphery 1930, British Pharmaceutical Codex 1949, WHO 2004). TTO has been used for vaginal infections and gynaecological conditions including vaginitis, cystitis and cervicitis (Penfold & Morrison 1937, Penfold & Morrison 1950, Humphery 1930, WHO 2004), irrigation of bladder and urethra (Anonymous 1933), symptomatic treatment of colitis (WHO 2004) and as an inhalant in coryza (British Pharmaceutical Codex 1949).
Assessment report on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum
EMA/HMPC/320932/2012 Page 9/73
Table 2: Traditional use of tea tree oil Reference Documented Use / Traditional Use Herbal preparation Posology Safety Comments Humphery 1930 Australia a) Cleaning of dirty or infected wounds and pus dissolution b) help wound healing c) peryonichia. d) as a gargle to clear up sore throats in the early stages e) for use in the vagina with no irritation f) help in clearing head cold symptoms. g) for nasopharynx h) for several parasitic skin diseases a)-f) 35% TTO saponified solution g) TTO diluted with paraffin a)
dilutions commencing from 2.5% to 10% b)
applied as impregnated dressing and changed every 24 hours c)
d)
20 drops in a glass of warm water e)
Stronger dilutions f)
a few drops inhaled from handkerchief g)
h)
as an ointment No apparent damage to the tissues even in quite strong solutions. Infections that had resisted treatments of various kinds for months were cured in less than a week.
1930 Australia as an antiseptic for special and general dental surgery Ti-Trol – 100% TTO Melasol – 40% TTO in water soluble emulsion
Anonymous 1933
Great Britain a) Use in dental, medical and surgical practice b) Use in a wide range of septic conditions c) for irrigation of bladder and the urethra a), b) Ti-Trol (100% TTO) a)–c) Melasol (40% TTO in water soluble emulsion) c) 100% Melasol solution powerful non- poisonous and non- irritant disinfectant
Assessment report on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum EMA/HMPC/320932/2012 Page 10/73
Penfold and Morrison 1937
Australia Extensive application in surgical and dental practice. Chronic leg ulcers and wounds Germicidal even in presence of blood and organic matter. Peryonichia (paronychia), empyema, gynaecological conditions, skin conditions including psoriasis, impetigo contagiosum, pediculosis, ringworm (tinea). Throat and mouth condition including acute nasopharyngitis, catarrh, thrush, aphthous stomatitis, tonsillitis, mouth ulcers, sore throat, pyorrhoea, gingivitis. Ti-Trol (100% TTO) Melasol (40% TTO in water soluble emulsion)
healed an unhealing head wound; Ti-Trol cleared tinea in many cases;
TiTrol and Melasol healed leg ulcers with pus not responding to other treatments; Melasol healed a chronic case of diabetic gangrene British Pharmaceutic al Codex 1949
Great Britain Germicidal properties. Local application for treatment of furunculosis, tinea, paronychia, impetigo, eczema, thrush, stomatitis. Inhalant in coryza. TTO
Stored in well- closed containers, protected from light and in a cool place
Penfold and Morrison 1950
Australia Extensive application in surgical and dental practice. Germicidal even in presence of blood and organic matter. Perionychia (paronychia), empyema, gynaecological conditions, diabetic gangrene. Skin conditions including psoriasis, impetigo contagiosa, pediculosis, ringworm (tinea). Throat and mouth condition including acute nasopharyngitis, catarrh, thrush, aphthous stomatitis, tonsillitis, mouth 100% TTO or a water soluble oil emulsion without relating to a specific indication
Pleasant odour, non-poisonous, non-irritant, non- corrosive. Ability to penetrate pus, acts to deslough, leaving a healthy surface. The germicidal activity is maintained and even increased in presence of organic matter.
Assessment report on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum EMA/HMPC/320932/2012 Page 11/73
ulcers, sore throat, pyorrhoea, gingivitis. Skin injuries and abrasions. Antiseptic agent in denture and mouth washes. Walker
1972 USA
Common foot problems: onychomycotic toenails Ti-Trol – 100% TTO
To be applied twice daily
helps make nails smoother and firmer but had little effect on organisms
Walker
1972 USA
Common foot problems: a) bromidrosis b) deodorant, healing of cracks and fissures, peeling and callused heels , inflammation of corns, calluses, bunions, hammertoes c) Post-operative wound healing of chemical matricectomies and post-surgical sutured wounds d) Relief of post-treatment dryness following copper sulphate iontophoresis for tinea pedis e) fungal preventative associated with tinea pedis Melasol (40% TTO in water soluble emulsion) e) 8% TTO in ointment preparation apply once daily or hydrotherapy daily application to the affected areas post-operative dressing, to be applied twice daily
1982 UK
Added to many disinfectant preparations TTO
Stored in cool place in air-tight containers, protected from light
Martindale 1993 UK
Reported to have bactericidal and fungicidal properties and is used topically for various skin disorders TTO
Stored in air-tight containers, protected from light
Uses supported by clinical data: topical TTO
external application at Contraindicated
EMA/HMPC/320932/2012 Page 12/73
Organization 2004 International application for symptomatic treatment of common skin disorders such as acne, tinea pedis, bromidrosis, furunculosis and mycotic onychia (onychomycosis) and of vaginitis due to Trichomonas vaginalis or
Uses described in pharmacopoeias and in traditional medicine: as an antiseptic and disinfectant for the treatment of wounds. Uses described in folk medicine: symptomatic treatment of burns, colitis, coughs and colds, gingivitis, impetigo, nasopharyngitis, psoriasis, sinus congestion, stomatitis, tonsillitis concentrations of 5- 100%, depending on skin disorder being treated for cases of known allergy to plants of the Myrtaceae family. Not for internal use. Keep out of reach of children. Store in a well- filled airtight container, protected from heat and light
Assessment report on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum EMA/HMPC/320932/2012 Page 13/73
2.2. Information on traditional/current indications and specified substances/preparations The leaves were macerated in water for a long period (hours or even days) and then used as infusion or impregnated dressing especially in treating common cold, sore throat, insect bites, wounds or fungal skin infections as well as in delousing (Saller et al. 1998). The essential oil had been used during the Second World War as a general antimicrobial agent and insect repellent, and provided in the first aid kits of serving Australian soldiers. The essential oil is nowadays used as a strong antimicrobial and antifungal agent in creams, soaps, toothpastes and other preparations and it has been used both externally and internally by both herbalists and aromatherapists (Lis-Balchin et al. 2000). In modern times, TTO is reputed to have several medicinal properties including antibacterial, antifungal, antiviral, anti-inflammatory and analgesic properties. For its antibacterial activity is today popular as a topical antimicrobial agent (Carson et al. 1998). It has been recommended in the treatment of many cutaneous conditions, including acne, eczema, furunculosis, onychomycosis and tinea (Carson et al. 2006). TTO enjoys remarkable popularity as a topical antimicrobial agent and, although it is marketed mainly for its well-documented antibacterial, antifungal and antiviral properties, the oil also has anti- inflammatory, analgesic, insecticidal and antipruritic properties (Edmonson et al. 2011). Currently it is also incorporated as the principal antimicrobial or as a natural preservative in many pharmaceutical and cosmetic products intended for external use (Cox et al. 2000). TTO has a number of characteristics which suggest potential for its use in wound treatments or protectants against fly strike. It has documented insecticidal effects, which could be of use in the treatment of larvae in strikes, and repellent effects (Callander & James 2011). In Australia, it has also a long history of clinical use in the treatment of foot problems such as tinea pedis and toenail onychomycosis. Dermatologic studies have been conducted in the treatment of acne, dandruff, head lice, and recurrent herpes labialis, in which effects were found to be either similar or better than traditional treatment, and often with fewer side effects. A few published studies report the successful use of TTO in treating mucous membrane infections, including Trichomonas vaginalis, and against oral bacteria and oropharyngeal candidiasis (Halcon & Milkus 2004). In Denmark it has been authorised for disinfection in acne and in fungal infections on the foot (1993- 2009).
In Sweden TTO is used against itch at mild athlete´s foot, for uncomplicated insect bites and for treatment of mild acne, in Hungary for treatment of skin infection, stomatitis, gingivitis, cut wounds, excoriation and acne.
TTO is usually topically applied at concentrations 0.05%-1.0% for treating microbial infections (Combest 1999). Tea tree preparations containing 10% and 100% TTO have been used in clinical trials to treat tinea pedis and onychomycosis, respectively (Buck et al. 1994; Tong et al. 1992).
Assessment report on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum
EMA/HMPC/320932/2012 Page 14/73
For treating athlete’s foot, it is advised to dilute the concentrated oil with an equal amount of water or vegetable oil and apply to the affected area three times a day with a cotton ball (Combest 1997). A topically applied 5% solution appears to be effective in treating acne (Bassett et al. 1990). Several published reports have addressed minimum inhibitory and bactericidal concentrations of TTO against clinical isolates of Staphylococcus. aureus. A study of 105 clinical isolates of S. aureus using a broth microdilution method found the MIC 90 (Minimal Inhibitory Concentration required to inhibit the growth of 90% of organisms) of TTO to be 0.5%. A later study of 100 clinical isolates of methicillin- resistant S. aureus (MRSA) found the MIC 90 of TTO to be 0.32% (Halcon & Milkus 2004). For application on the skin TTO should always be diluted before use. In Sweden it is diluted in olive oil or baby oil 1:9 and dabbed on the afflicted areas of the skin 1-3 times daily. The rate of dilution in Denmark was 1:9 as well. The use is not recommended for children under 12 years of age. In acne or athlete’s foot the maximum duration of use is 1 month of treatment. In Hungary the daily dose for cutaneous use is 10-15 drops (corresponding to 0.33–0.5 ml or 0.3147- 0.47205 g) to be stirred in 50 ml of lukewarm water and the solution is applied on the skin with a sterile cotton wool or gauze. In case of stomatitis and gingivitis 5-10 drops (corresponding to 0.17– 0.33 ml or 0.15735-0.47205 g) to be mixed in 100 ml of water for gargle several times daily (1 ml is 30 drops and 1g is about ~32 drops). If the symptoms do not improve after 5 days treatment the use of products should be stopped. Table 3: Information on preparations of TTO grouped according to the traditional use Herbal preparation Pharmaceutical form Indication Strength Posology Period of medicinal use solution readily miscible in water containing 35% of TTO (saponified) a) to dissolve pus, to clean surface of infected wounds b) to wash or syringe out dirty wounds to loosen and remove debris. c) to help with healing d) as an ointment for several parasitic skin diseases a) 35% TTO saponified solution at various water dilutions commencing from 2.5% b) 10% watery lotion c) Dressings dipped in 2.5% solution to be applied to wound and changed every 24 hours d) TTO diluted with paraffin (no further specification) 1930 Humphery Australia TTO for local application Use as an antiseptic for special and general dental surgery 100% TTO or
40% TTO in water soluble emulsion (Melasol) 1930
MacDonald Australia TTO for local application Extensive application in surgical and dental practice. Chronic leg ulcers and wounds including an ability to Refers to 100% oil or a water soluble oil emulsion (Melasol) without relating to a specific indication 1937
Penfold and Morrison Australia
and/or other species of Melaleuca, aetheroleum
EMA/HMPC/320932/2012 Page 15/73
Herbal preparation Pharmaceutical form Indication Strength Posology Period of medicinal use penetrate pus, acts to deslough, leaving a healthy surface. Germicidal properties retained even in presence of blood and organic matter. Skin conditions including psoriasis, impetigo contagiosum, pediculosis, ringworm (tinea). TTO for local application Impetigo Not specified 1949 British Pharmaceutical Codex (UK) TTO for local application Extensive application in surgical and dental practice. Ability to penetrate pus, acts to deslough, leaving a healthy surface. Germicidal properties retained even in presence of blood and organic matter. Skin conditions including psoriasis, impetigo contagiosa, pediculosis, ringworm (tinea). Skin injuries and abrasions. Refers to 100% oil or a water soluble oil emulsion (Melasol) without relating to a specific indication 1950 Penfold and Morrison Australia TTO for local application Added to many disinfectant preparations No further specification 1982
Martindale (UK) Cutaneous liquid for uncomplicated insect bites TTO diluted in olive oil or baby oil 1:9 (10%) and dabbed on the afflicted areas of the skin 1-3 times daily. Maximum duration of use 1 month. Not recommended for children under 12 years of age. Since 1988 (Sweden) TTO for local application used topically for various skin disorders for its bactericidal No further specification 1993
Martindale (UK)
Assessment report on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum
EMA/HMPC/320932/2012 Page 16/73
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