Pilot Study to Evaluate Tea Tree Oil Gel for Facial Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Tea tree oil
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): melaleuca oil; Thursday Plantation
Intervention MeSH terms: Tea Tree Oil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acne; inflamed lesions; non-inflamed lesions; complementary medicine; essential oil