None listed
Conditions
Brief summary
Acne is a common, chronic and sometimes severe skin condition affecting up to 93% of 16 to 18 year olds. It is dismissed as an adolescent disorder, but the physical and psychosocial symptoms can continue into adulthood. Over-the-counter and prescription medications are clinically effective but adherence is poor, often due to an unacceptable side-effect profile. Aromatherapy is the controlled application of essential oils for improved health and well-being, and a potential treatment for acne. In vitro studies have found essential oils to be effective against Propionibacterium acnes, but there is scant evidence of clinical effectiveness. Tea tree oil is a proven effective treatment, but the strong odour and known side-effects can hinder its therapeutic value. The impact of consultation on clinical outcomes is documented in mental health, psychotherapy and CAM modalities but not reported for aromatherapy. Aim: To explore the clinical and cost-effectiveness of aromatherapy treatment for the physical and psychological symptoms of acne. Methods: The proposed study will be a prospective, randomised wait-list controlled trial. 300 participants will be recruited through TAFE colleges and block randomised to one of three trial arms. 1) usual care (wait-list control) 2) standard blend of essential oils 3) individualised aromatherapy treatment (in-depth consultation and bespoke blend of essential oils). Data will be collected on the physical symptoms of acne and quality of life (using the AQOL-8D). Costs of treatment will be collected also. The clinical and cost effectiveness of the two aromatherapy treatment options for acne will be compared with each other and against usual care. Null Hypothesis related to primary clinical outcomes a) Aromatherapy consultation (treatment arm 2) is no more effective than a standard essential oil blend (treatment arm 1) or wait-list control (usual treatment) in reducing acne severity at 12 weeks. b) A standard essential oil blend is no more effective than wait-list control in reducing acne severity at 12 weeks
Interventions
Arm 1 - Standard blend of essential oils to be applied topically to the symptoms of facial acne vulgaris. This blend of essential oils will be selected from a list of twenty-three oils (this same list of oils will form the basis of the blends produced for Arm 2 group and is listed at the end of this description). Essential oils will be blended in 100 ml pump bottle to be applied to clean skin twice daily for twelve weeks. The recommended dose is 0.7 ml (one "pump" of the applicator). The ble
Arm 1 - Standard blend of essential oils to be applied topically to the symptoms of facial acne vulgaris. This blend of essential oils will be selected from a list of twenty-three oils (this same list of oils will form the basis of the blends produced for Arm 2 group and is listed at the end of this description). Essential oils will be blended in 100 ml pump bottle to be applied to clean skin twice daily for twelve weeks. The recommended dose is 0.7 ml (one "pump" of the applicator). The blend will be a 2.5% dilution in a base of jojoba; the largest individual essential oil dose will be no larger than 1%. Arm 2 - Bespoke blend of essential oils; participants will receive an in-depth consultation (45 minutes) at the initial meeting with the investigator (a qualified aromatherapist), from which an individually tailored 5% blend of essential oils will be determined; this blend will be from a list of essential oils (below) and consist of five oils with the largest dose of oils being no more than 1% of the total oil product, the basis of which will be jojoba. be applied topically to the symptoms of facial acne vulgaris. Oils will be blended in 100 ml pump bottle to be applied to clean skin twice daily for twelve weeks. The recommended dose is 0.7 ml (one "pump" of the applicator). Aniba rosaeodora (Rosewood) Boswellia carterii (Frankincense) Cananga odorata (Ylang ylang) Cedrus atlantica (Cedarwood) Citrus aurantium (Petitgrain) Citrus bergamia (Bergamot) Bergaptene free Citrus paradisi (Grapefruit) Citrus sinensis (Sweet orange) Cupressus sempervirens (Cypress) Elettaria cardamomum (Cardamom) Juniperus communis (Juniperberry) Lavandula angustifolia (Lavender) Matricaria chamomilla (German Chamomile) Melaleuca alternifolia (Tea tree) Melaleuca quinquenervia (Niaouli) Mentha piperata (Peppermint) Pelargonium graveolens (Geranium) Pogostemon cablin (Patchouli) Rosmarinus officinalis (Rosemary) Salvia sclarea (Clary sage)
Sponsors
University South Australia
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
15 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Observable facial acne Be willing to remove make-up thirty minutes prior to clinical examination.
Exclusion criteria
Pregnant or breast-feeding mothers History kidney or liver disease receiving or completed within past eight weeks, warfarin, tetracycline, minocycline, lymecycline, erythromycin, isotretinoin, zinc, oral contraceptive containing cyproterone acetate has epilepsy open wounds to face acute infection.
Outcome results
None listed