Acne | Pilot Study to Evaluate Tea Tree Oil Gel for Facial Acne
Acne research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Tea tree oilPea-sized amount of tea tree oil medicated gel (containing 200mg/g tea tree oil) applied to the face twice daily for 12 weeks.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Tea tree oilPea-sized amount of tea tree oil medicated gel (containing 200mg/g tea tree oil) applied to the face twice daily for 12 weeks.
Start Date: December 2012
Completed Date: December 2014
Phase: Phase 2
Primary Outcome: Lesion numbers
Secondary Outcome: Decreased non-inflammatory lesion count
Study sponsors, principal investigator, and references
Principal Investigator: Prasad Kumarasinghe
Lead Sponsor: The University of Western Australia
Collaborator: Royal Perth Hospital
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. Review.