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Trial registered on ANZCTR


Registration number
ACTRN12612000193875
Ethics application status
Not yet submitted
Date submitted
10/01/2012
Date registered
14/02/2012
Date last updated
14/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The clinical and cost effectiveness of aromatherapy for the treatment of acne vulgaris: A Randomised Controlled Trial
Scientific title
Among males and females aged 15 to 45 with the physical symptoms of facial acne vulgaris, is aromatherapy treatment including consultation and a bespoke blend of essential oils comparable to the topical application of a predetermined blend of essential oils or current, over-the-counter treatment for resolution of acne symptoms
Secondary ID [1] 279701 0
Nil
Universal Trial Number (UTN)
U1111-1127-0007
Trial acronym
CLEANsE (CLinical Essential Oil AcNe Effectiveness) Research
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne vulgaris 285534 0
Condition category
Condition code
Skin 285725 285725 0 0
Dermatological conditions
Alternative and Complementary Medicine 286031 286031 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 283995 0
Treatment: Other
Comparator / control treatment
Wait-list control, Treatment Arm 1. At the end of the three-month control period, participants in the wait-list control will be offered three months of Treatment Arm 1 essential oil blend, as well as information regarding diet, hygiene and stress, and be advised that they can phone the investigator if they experience any side effects.
Control group
Active

Outcomes
Primary outcome [1] 286249 0
Severity of acne: Acne severity is defined as the classification and characterisation of acne vulgaris. This will be assessed using the Leeds revised acne severity scale and supported with clinical photography.
Timepoint [1] 286249 0
Weeks 0, 4, 8 and 12.
Primary outcome [2] 286250 0
Quality of Life: This self-perceived outcome will be assessed using the Acne Specific Quality of Life questionnaire and the Assessment of Quality of Life-8D for adolescents
Timepoint [2] 286250 0
Weeks 0, 4, 8 and 12.
Primary outcome [3] 286251 0
Subjective Symptom Assessment: The Measure Yourself Medical Outcome Profile 2 (MYMOP2) is an outcome questionnaire which is created by the patient, who chooses one symptom (physical, emotional or social) and measures that symptom at each appointment.
Timepoint [3] 286251 0
Weeks 0, 4, 8 and 12.
Secondary outcome [1] 295448 0
Cost: The cost of treatment will be calculated in Australian dollars for the individual participants based on the costs of the essential oils and consultation time; these costs will be compared between consultation groups. The cost of usual care will be assessed according to the descriptions of usual treatment provided by participants in the wait-list control group. The cost of therapeutic consultation will be included.
Timepoint [1] 295448 0
End of data collection period

Eligibility
Key inclusion criteria
Observable facial acne
Be willing to remove make-up thirty minutes prior to clinical examination.
Minimum age
15 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284483 0
University
Name [1] 284483 0
University South Australia
Country [1] 284483 0
Australia
Primary sponsor type
University
Name
University South Australia
Address
GPO Box 2471
Adelaide, South Australia 5001
Country
Australia
Secondary sponsor category [1] 283407 0
None
Name [1] 283407 0
Address [1] 283407 0
Country [1] 283407 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286462 0
University South Australia Human Research Ethics
Ethics committee address [1] 286462 0
GPO Box 2471
Adelaide, South Australia 5001
Ethics committee country [1] 286462 0
Australia
Date submitted for ethics approval [1] 286462 0
23/01/2012
Approval date [1] 286462 0
Ethics approval number [1] 286462 0

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33612 0
Address 33612 0
Country 33612 0
Phone 33612 0
Fax 33612 0
Email 33612 0
Contact person for public queries
Name 16859 0
Tamara Agnew
Address 16859 0
School of Nursing and Midwifery
Division of Health Sciences
University South Australia
GPO Box 2471
Adelaide, South Australia, 5001
Country 16859 0
Australia
Phone 16859 0
+61 8 8302 2475
Fax 16859 0
Email 16859 0
[email protected]
Contact person for scientific queries
Name 7787 0
Tamara Agnew
Address 7787 0
School of Nursing and Midwifery
Division of Health Sciences
University South Australia
GPO Box 2471
Adelaide, South Australia, 5001
Country 7787 0
Australia
Phone 7787 0
+61 8 8302 2475
Fax 7787 0
Email 7787 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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