Pilot Study to Evaluate Tea Tree Oil Gel for Facial Acne

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by The University of Western Australia
Sponsor:
Collaborators:
Royal Perth Hospital
Hollywood Private Hospital
Information provided by (Responsible Party):
Katherine Hammer, The University of Western Australia
ClinicalTrials.gov Identifier:
NCT01657110
First received: August 1, 2012
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Acne
Other: Tea tree oil
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by The University of Western Australia:

Primary Outcome Measures:
  • Lesion numbers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Numbers of inflamed and non-inflamed facial lesions will be counted.

  • Investigator Global Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Decreased non-inflammatory lesion count [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Decrease in numbers of non-inflammatory lesions from baseline

  • Decreased inflammatory lesion count [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Decrease in inflammatory lesion count from baseline

  • Decrease in perceived facial oiliness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Decrease in perceived facial oiliness from baseline


Other Outcome Measures:
  • Mean tolerability score [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    Mean tolerability will be determined as the average of the following;

    1. Erythema
    2. Scaling
    3. Peeling
    4. Burning
    5. Induration
    6. Dryness

    These six parameters will be measured using a 5-point scale (0: None, 1: Minimal, 2: Mild, 3: Moderate, 4: Severe). Mean tolerability will be the average of these scores.


  • The frequency of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Any local or systemic adverse events will be recorded including the type of reaction and severity (on a 5-point severity scale where 0 = none and 4 = severe).


Estimated Enrollment: 18
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned 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.
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 Names:
  • melaleuca oil
  • Thursday Plantation

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.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657110

Contacts
Contact: Kate Hammer, PhD katherine.hammer@uwa.edu.au

Locations
Australia, Western Australia
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia
Contact: Katherine Hammer    +61 8 6383 4363      
Australia
Hollywood Private Hospital Recruiting
Perth, Australia
Contact: Prasad Kumarasinge    +61 8 9389 6736      
Principal Investigator: Prasad Kumarasinghe         
Sponsors and Collaborators
The University of Western Australia
Royal Perth Hospital
Hollywood Private Hospital
Investigators
Principal Investigator: Prasad Kumarasinghe Royal Perth Hospital
  More Information

Publications:
Responsible Party: Katherine Hammer, Research Assistant Professor, The University of Western Australia
ClinicalTrials.gov Identifier: NCT01657110     History of Changes
Other Study ID Numbers: PRJ-006245
Study First Received: August 1, 2012
Last Updated: June 28, 2013
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The University of Western Australia:
acne
inflamed lesions
non-inflamed lesions
complementary medicine
essential oil

Additional relevant MeSH terms:
Tea Tree Oil
Anti-Infective Agents
Anti-Infective Agents, Local
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014