Pilot Study to Evaluate Tea Tree Oil Gel for Facial Acne
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
1 other identifier
interventional
18
1 country
2
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 3, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 28, 2015
January 1, 2015
2 years
August 1, 2012
January 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Lesion numbers
Numbers of inflamed and non-inflamed facial lesions will be counted.
12 weeks
Investigator Global Assessment
A 5-point severity scale (0-4) will be used to give an overall acne grade. 0: Clear skin with no lesions 1. Almost clear; rare lesions 2. Mild severity; some non-inflammatory lesions with no more than a few inflammatory lesions 3. Moderate severity; up to many non-inflammatory lesions and may have some inflammatory lesions 4. Severe; up to many noninflammatory and inflammatory lesions but no more than a few nodular lesions
12 weeks
Secondary Outcomes (3)
Decreased non-inflammatory lesion count
12 weeks
Decreased inflammatory lesion count
12 weeks
Decrease in perceived facial oiliness
12 weeks
Other Outcomes (2)
Mean tolerability score
12 weeks
The frequency of adverse events
12 weeks
Study Arms (1)
Tea tree oil
OTHERPea-sized amount of tea tree oil medicated gel (containing 200mg/g tea tree oil) applied to the face twice daily for 12 weeks.
Interventions
Pea-sized amount of tea tree oil medicated gel (containing 200mg/g tea tree oil) applied to the face twice daily for 12 weeks.
Eligibility Criteria
You may qualify if:
- Aged 16 - 45 years
- Mild to moderate facial acne with 10 - 100 lesions
- Investigator Global Assessment score of at least 2
- Able to comply with the requirements of the protocol and attend the outpatients clinic at 2, 4, 8 and 12 weeks
- Able to provide written informed consent
You may not qualify if:
- More than 2 acne nodules
- Allergy to tea tree oil or any component of the study drug
- Current skin disease (other than acne)
- Facial hair that may obscure acne lesions
- Use of topical or systemic steroids within the last 2 or 4 weeks, respectively
- Use of topical or systemic antibiotics within the last 2 or 4 weeks, respectively
- Use of topical acne treatments (eg. benzoyl peroxide, salicylates, retinoids) within the last 2 weeks
- Use of systemic retinoids within the past 6 months
- Procedures on the face such as peels, laser therapy or microdermabrasion within the past 4 weeks
- Women who are pregnant or breastfeeding
- 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.
- Participation in another clinical trial during the last 12 weeks
- Concurrent diseases which exclude the administration of therapy as outlined by the study protocol
- Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration
- Chronic lung disease with hypoxemia
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Western Australialead
- Royal Perth Hospitalcollaborator
- Hollywood Private Hospitalcollaborator
Study Sites (2)
Royal Perth Hospital
Perth, Western Australia, Australia
Hollywood Private Hospital
Perth, Australia
Related Publications (1)
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.
PMID: 16418522BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prasad Kumarasinghe
Royal Perth Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
August 1, 2012
First Posted
August 3, 2012
Study Start
December 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 28, 2015
Record last verified: 2015-01