Trial registered on ANZCTR


Trial ID
ACTRN12605000233628
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
26/08/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of Tea Tree oil on acne
Scientific title
The effects of Tea Tree oil on acne
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne vulgaris lesions 319 0
Condition category
Condition code
Skin 364 364 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tea tree oil formulation
Intervention code [1] 242 0
Treatment: Other
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 424 0
Decrease in the number of pustules and other lesions
Timepoint [1] 424 0
Measured daily by photography and interpreted at the end of the study.
Secondary outcome [1] 915 0
Subject perception of changes in acne
Timepoint [1] 915 0
Measured daily

Eligibility
Key inclusion criteria
Good general health aged
Minimum age
14 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Each subject provided their own internal control. The right and left sides of the subjects' faces were randomly assigned to treatments, with one side of the face treated with the preparation and the other side 'treated' with a placebo. Each participant had a specific number and the treatments were supplied by the sponsor in numbered tubes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were assigned to a number on a first come, first entered basis. (i.e. the first recruited person was recorded as number 1)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 423 0
Commercial sector/Industry
Name [1] 423 0
Attori Pty Ltd
Address [1] 423 0
Country [1] 423 0
Primary sponsor type
Commercial sector/Industry
Name
Attori Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 342 0
None
Name [1] 342 0
None
Address [1] 342 0
Country [1] 342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1395 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 1395 0
Ethics committee country [1] 1395 0
Australia
Date submitted for ethics approval [1] 1395 0
Approval date [1] 1395 0
Ethics approval number [1] 1395 0

Summary
Brief summary
Potential subjects attended a screening clinic where they were assessed by the principal investigators. Those included were photographed (full face and left and right profile) and the film and frame numbers recorded in the subjectÿ¢ÿ¿ÿ¿s records. The study nurse, who was blinded throughout the study by the wearing of a rhino clip, then applied the active and placebo treatments to opposite sides of the face and forehead. Fresh gloves were worn during the application of each separate treatment.

In subsequent clinics a study nurse washed and dried the subjectÿ¢ÿ¿ÿ¿s face with a mild dermatological soap and recorded subjective opinions of perceived changes in acne. Four photographs were taken of each subjectÿ¢ÿ¿ÿ¿s face representing the upper and lower parts of each of the treated and placebo sides. Active and placebo treatments were applied as described above.

Subjects were photographed using a Minolta Dynax 600si camera with a Sigma 105mL macro lens, multi-directional studio flash lighting with soft boxes and Fuji Reala film. This film was used because it has high acutance and extended tunnel range. Colour was standardised against 18% grey card to ensure reproducibility. The camera was fixed to a tripod and the position marked on the floor to maintain consistency in future photography.

Subjects were collected and returned to their homes by a University car to maximise compliance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35734 0
Address 35734 0
Country 35734 0
Phone 35734 0
Fax 35734 0
Email 35734 0
Contact person for public queries
Name 9431 0
Professor Stephen Myers
Address 9431 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9431 0
Australia
Phone 9431 0
+61 2 66203403
Fax 9431 0
+61 2 66203307
Email 9431 0
smyers@scu.edu.au
Contact person for scientific queries
Name 359 0
Joan O'Connor
Address 359 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 359 0
Australia
Phone 359 0
+61 2 66203649
Fax 359 0
+61 2 66203307
Email 359 0
joconnor@scu.edu.au