AcnePhase 2NCT01657110
Pilot Study to Evaluate Tea Tree Oil Gel for Facial Acne
A Phase 2 study testing Tea tree oil in people with Acne, run by The University of Western Australia at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Acne
- What is being tested?
- Tea tree oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesAustralia
- Study dates
- Dec 2012to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
- Myocardial infarction during the last 6 months
- Non-compensated heart failure
- Severe non-compensated hypertension
- Severe non-compensated diabetes mellitus
- Severe psychiatric disease
- Known HIV or active chronic hepatitis B or C infection
- Subjects who, in the opinion of the investigator, are not likely to complete the study for what ever reason.
- Subjects who, in the opinion of the investigator, abuse alcohol or drugs
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Royal Perth Hospital
Perth, Western Australia
Hollywood Private Hospital
Perth
About this study
Official 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
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.
Read the detailed description
Tea tree oil is the essential oil obtained from the Australian plant Melaleuca alternifolia. The oil has been used in Australia for many decades as a topically applied antiseptic and has been used to treat bites, stings, cuts and grazes. Many studies have shown that tea tree oil has both antimicrobial and anti-inflammatory activity in the laboratory. In addition, clinical trials have demonstrated that the oil can help in treating conditions such as dandruff, tinea, colonisation with methicillin resistant Staphylococcus aureus (MRSA) in the nose and acne. Together, these laboratory and clinical studies indicate that tea tree oil can potentially be used to treat relatively minor skin infections or diseases.
This pilot study aims to investigate whether a commercially available gel containing tea tree oil is effective for treating mild to moderate facial acne. A minimum of 18 participants that meet the inclusion and exclusion criteria will be enrolled in the study. Participants will be instructed to apply the tea tree oil gel each morning and night for 12 weeks and their acne will be assessed after 4, 8 and 12 weeks of treatment. Acne severity will be measured by (1) counting the numbers of lesions (pimples) on the face and (2) assigning an overall acne severity score. The lesion counts and severity scores at 4, 8 and 12 weeks will be compared to the baseline count to evaluate whether the acne is improving.
Potential benefits to participants, and of the study, are that their acne may improve as a result of treatment and that the results of the study may provide evidence that a commercially available product is effective for treating acne. There are many over-the-counter topically applied products available for treating acne. Two of the most common active ingredients are benzoyl peroxide and salicylic acid. Benzoyl peroxide is an antibacterial agent that works by killing the P. acnes bacterium on the skin. Although it is relatively effective for treating acne, it can also be quite irritating, especially when patients first start to use it. Salicylic acid acts by helping to unblock pores and remove excess dead skin thus helping pimples to heal more quickly. However, it is generally not as effective as benzoyl peroxide. One previous study has shown that a gel containing 5% tea tree oil performed similarly to benzoyl peroxide for reducing pimples, suggesting that it warrants further study.
Since a small percentage of people (approximately 1.4%) are allergic to tea tree oil all participants will be monitored for any reactions to the study product. Tea tree oil allergy typically manifests as redness and swelling and the site of application. This is one of the possible risks to participants, however, given the small numbers of study participants the likelihood of one or more participants having a reaction to the oil is low. Another possible risk is that participants may not benefit from the treatment and that their acne may not improve.
- Conditions
- Acne
- Being tested
- Tea tree oil
- Keywords
- acne, inflamed lesions, non-inflamed lesions, complementary medicine, essential oil
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tea tree oilOther
Also called melaleuca oil, Thursday Plantation
Pea-sized amount of tea tree oil medicated gel (containing 200mg/g tea tree oil) applied to the face twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tea tree oil | Other | Pea-sized amount of tea tree oil medicated gel (containing 200mg/g tea tree oil) applied to the face twice daily for 12 weeks. Receives: Other: Tea tree oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion numbers
Numbers of inflamed and non-inflamed facial lesions will be counted.
Measured: 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
- Almost clear; rare lesions
- Mild severity; some non-inflammatory lesions with no more than a few inflammatory lesions
- Moderate severity; up to many non-inflammatory lesions and may have some inflammatory lesions
- Severe; up to many noninflammatory and inflammatory lesions but no more than a few nodular lesions
Measured: 12 weeks
Secondary outcomes (3)
Decreased non-inflammatory lesion count
Decrease in numbers of non-inflammatory lesions from baseline
Measured: 12 weeks
Decreased inflammatory lesion count
Decrease in inflammatory lesion count from baseline
Measured: 12 weeks
Decrease in perceived facial oiliness
Decrease in perceived facial oiliness from baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Perth Hospital, Hollywood Private Hospital
- Responsible party
- Principal investigator, Katherine Hammer, The University of Western Australia
- Investigators
- Prasad Kumarasinghe, Principal investigator, Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657110
- Sponsor's protocol ID
- PRJ-006245
- Status last verified
- Jan 2015
- First submitted
- 1 Aug 2012
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 16418522
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01657110
- Acronym / sponsor ID
- PRJ-006245
- Conditions
- Acne
- Keywords
- acne, inflamed lesions, non-inflamed lesions, complementary medicine, essential oil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Collaborators
- Royal Perth Hospital, Hollywood Private Hospital
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tea tree oil is the essential oil obtained from the Australian plant Melaleuca alternifolia. The oil has been used in Australia for many decades as a topically applied antiseptic and has been used to treat bites, stings, cuts and grazes. Many studies have shown that tea tree oil has both antimicrobial and anti-inflammatory activity in the laboratory. In addition, clinical trials have demonstrated that the oil can help in treating conditions such as dandruff, tinea, colonisation with methicillin resistant Staphylococcus aureus (MRSA) in the nose and acne. Together, these laboratory and clinical studies indicate that tea tree oil can potentially be used to treat relatively minor skin infections or diseases.
This pilot study aims to investigate whether a commercially available gel containing tea tree oil is effective for treating mild to moderate facial acne. A minimum of 18 participants that meet the inclusion and exclusion criteria will be enrolled in the study. Participants will be instructed to apply the tea tree oil gel each morning and night for 12 weeks and their acne will be assessed after 4, 8 and 12 weeks of treatment. Acne severity will be measured by (1) counting the numbers of lesions (pimples) on the face and (2) assigning an overall acne severity score. The lesion counts and severity scores at 4, 8 and 12 weeks will be compared to the baseline count to evaluate whether the acne is improving.
Potential benefits to participants, and of the study, are that their acne may improve as a result of treatment and that the results of the study may provide evidence that a commercially available product is effective for treating acne. There are many over-the-counter topically applied products available for treating acne. Two of the most common active ingredients are benzoyl peroxide and salicylic acid. Benzoyl peroxide is an antibacterial agent that works by killing the P. acnes bacterium on the skin. Although it is relatively effective for treating acne, it can also be quite irritating, especially when patients first start to use it. Salicylic acid acts by helping to unblock pores and remove excess dead skin thus helping pimples to heal more quickly. However, it is generally not as effective as benzoyl peroxide. One previous study has shown that a gel containing 5% tea tree oil performed similarly to benzoyl peroxide for reducing pimples, suggesting that it warrants further study.
Since a small percentage of people (approximately 1.4%) are allergic to tea tree oil all participants will be monitored for any reactions to the study product. Tea tree oil allergy typically manifests as redness and swelling and the site of application. This is one of the possible risks to participants, however, given the small numbers of study participants the likelihood of one or more participants having a reaction to the oil is low. Another possible risk is that participants may not benefit from the treatment and that their acne may not improve.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tea tree oil | Other | 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. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tea tree oilAlso: melaleuca oil, Thursday PlantationPea-sized amount of tea tree oil medicated gel (containing 200mg/g tea tree oil) applied to the face twice daily for 12 weeks. | Other | Tea tree oil |
Primary outcome
Lesion numbers
Time frame: 12 weeks
Numbers of inflamed and non-inflamed facial lesions will be counted.
Investigator Global Assessment
Time frame: 12 weeks
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
3 secondary outcomes
Decreased non-inflammatory lesion count
Time frame: 12 weeks
Decreased inflammatory lesion count
Time frame: 12 weeks
Decrease in perceived facial oiliness
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
- Background: PubMed 16418522Carson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prasad Kumarasinghe principal investigator
Royal Perth Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tea tree oil in people with Acne, run by The University of Western Australia at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion numbers (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01657110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.