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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01657110




Registration number
NCT01657110
Ethics application status
Date submitted
1/08/2012
Date registered
3/08/2012
Date last updated
28/01/2015

Titles & IDs
Public title
Pilot Study to Evaluate Tea Tree Oil Gel for Facial Acne
Scientific title
Uncontrolled, Open-label, Phase II Pilot Study to Evaluate the Efficacy, Tolerability and Acceptability of 200mg/g Tea Tree Oil Gel Applied Topically Twice Daily for the Treatment of Mild to Moderate Facial Acne
Secondary ID [1] 0 0
PRJ-006245
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Tea tree oil

Other: Tea tree oil - Pea-sized amount of tea tree oil medicated gel (containing 200mg/g tea tree oil) applied to the face twice daily for 12 weeks.


Other interventions: Tea tree oil
Pea-sized amount of tea tree oil medicated gel (containing 200mg/g tea tree oil) applied to the face twice daily for 12 weeks.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lesion numbers
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Investigator Global Assessment
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
Decreased non-inflammatory lesion count
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Decreased inflammatory lesion count
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Decrease in perceived facial oiliness
Timepoint [3] 0 0
12 weeks

Eligibility
Key inclusion criteria
1. Aged 16 - 45 years

2. Mild to moderate facial acne with 10 - 100 lesions

3. Investigator Global Assessment score of at least 2

4. Able to comply with the requirements of the protocol and attend the outpatients clinic
at 2, 4, 8 and 12 weeks

5. Able to provide written informed consent
Minimum age
16 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. More than 2 acne nodules

2. Allergy to tea tree oil or any component of the study drug

3. Current skin disease (other than acne)

4. Facial hair that may obscure acne lesions

5. Use of topical or systemic steroids within the last 2 or 4 weeks, respectively

6. Use of topical or systemic antibiotics within the last 2 or 4 weeks, respectively

7. Use of topical acne treatments (eg. benzoyl peroxide, salicylates, retinoids) within
the last 2 weeks

8. Use of systemic retinoids within the past 6 months

9. Procedures on the face such as peels, laser therapy or microdermabrasion within the
past 4 weeks

10. Women who are pregnant or breastfeeding

11. Women of childbearing potential not using a reliable contraceptive method.
Participants taking oral contraceptives must have been taking their current
contraceptive for the previous 3 months and must agree to continue with it until study
completion.

12. Participation in another clinical trial during the last 12 weeks

13. Concurrent diseases which exclude the administration of therapy as outlined by the
study protocol

14. Serious, uncontrolled disease (including serious psychological disorders) likely to
interfere with the study and/or likely to cause death within the study duration

15. Chronic lung disease with hypoxemia

16. Myocardial infarction during the last 6 months

17. Non-compensated heart failure

18. Severe non-compensated hypertension

19. Severe non-compensated diabetes mellitus

20. Severe psychiatric disease

21. Known HIV or active chronic hepatitis B or C infection

22. Subjects who, in the opinion of the investigator, are not likely to complete the study
for what ever reason.

23. Subjects who, in the opinion of the investigator, abuse alcohol or drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 0 0
Hollywood Private Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Perth Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Hollywood Private Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Mild to moderate facial acne is an extremely common disease of teenagers and young adults.
This pilot study will investigate whether treatment with a gel containing tea tree oil
reduces numbers of acne lesions and improves acne in twenty otherwise healthy consenting
participants. The hypothesis is that treatment with tea tree oil gel will result in a
significant improvement in acne after 12 weeks of treatment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01657110
Trial related presentations / publications
Carson CF, Hammer KA, Riley TV. Melaleuca alternifolia (Tea Tree) oil: a review of antimicrobial and other medicinal properties. Clin Microbiol Rev. 2006 Jan;19(1):50-62. doi: 10.1128/CMR.19.1.50-62.2006.
Public notes

Contacts
Principal investigator
Name 0 0
Prasad Kumarasinghe
Address 0 0
Royal Perth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01657110