Australasian Journal of Dermatology (2017) 58, 205–210 doi: 10.1111/ajd.

12465

ORIGINAL RESEARCH

Tea tree oil gel for mild to moderate acne; a 12 week

uncontrolled, open-label phase II pilot study
Harsimran Kaur Malhi,1 Jenny Tu,2 Thomas V Riley,3,4 Sujith Prasad Kumarasinghe2,5 and
Katherine A Hammer4
1
Department of General Medicine, St John of God Hospital, Perth, Western Australia, 2Department of
Dermatology, Royal Perth Hospital, Perth, Western Australia, 3PathWest Laboratory Medicine WA, Queen
Elizabeth II Medical Centre, Perth, Western Australia, 4School of Pathology and Laboratory Medicine (M504),
University of Western Australia, Perth, Western Australia, and 5Hollywood Medical Centre, Perth, Western
Australia, Australia

ABSTRACT Conclusion: This study shows that the use of the

tea tree oil products significantly improved mild to
Background: The efficacy, tolerability and accept- moderate acne and that the products were well
ability of a tea tree oil gel (200 mg/g) and face wash
tolerated.
(7 mg/g) were evaluated for the treatment of mild to
moderate facial acne. Key words: alternative treatment, essential oil,
Methods: In this open-label, uncontrolled phase II in vivo efficacy, terpenes, propionibacterium,
pilot study, participants applied tea tree oil products topical therapy.
to the face twice daily for 12 weeks and were
assessed after 4, 8 and 12 weeks. Efficacy was deter-
mined from total numbers of facial acne lesions and
the investigator global assessment (IGA) score. Tol-
erability was evaluated by the frequency of adverse INTRODUCTION
events and the mean tolerability score determined at
Acne is a common skin disease caused by a combination
each visit. Product acceptability was assessed via a
of factors including inflammation, excessive sebum pro-
questionnaire at the end of the study period.
duction, abnormal desquamation of the follicular epithe-
Results: Altogether 18 participants were enrolled,
lium and an immunological response to Propionibacterium
of whom 14 completed the study. Mean total lesion
acnes.1 Acne occurs primarily in adolescents and young
counts were 23.7 at baseline, 17.2 at 4, 15.1 at 8 and
adults with up to 90% of adolescents affected at some
10.7 at 12 weeks. Total lesion counts differed signifi-
stage.2 In addition, persistent or late onset acne occurs in
cantly over time by repeated measures ANOVA
adults, with prevalence rates higher than 50% reported in
(P < 0.0001). The mean IGA score was 2.4 at base-
some studies.3 Aside from discomfort and potential scar-
line, 2.2 at 4, 2.0 at 8 and 1.9 at 12 weeks, which also
ring, acne may cause severe emotional and psychological
differed significantly over time (P = 0.0094). No seri-
distress to sufferers.4
ous adverse events occurred and minor local tolera-
Acne can be treated with a range of agents, either
bility events were limited to peeling, dryness and
applied topically or taken orally. Major modes of action for
scaling, all of which resolved without intervention.
common acne treatment agents are antimicrobial activity,
anti-inflammatory action, the normalisation of follicular
hyperkeratinisation and the reduction of sebum produc-
tion.1 Those with mild acne commonly elect to self-treat
with over-the-counter acne treatment products and a
Correspondence: Dr Katherine A. Hammer, School of Pathology
and Laboratory Medicine (M504), University of Western Australia, recent study shows that products containing tea tree oil
35 Stirling Highway, Crawley, Western Australia 6009, Australia. are a popular choice.5 Tea tree oil is an essential oil
Email: katherine.hammer@uwa.edu.au
Harsimran Kaur Malhi, MBBS. Jenny Tu, FACD. Thomas V Riley,
Abbreviations:
PhD. Sujith Prasad Kumarasinghe, FACD. Katherine A Hammer,
PhD. IGA investigator global assessment
Conflict of interest: none. MIC minimum inhibitory concentration
Submitted 3 December 2015; accepted 25 January 2016.

© 2016 The Australasian College of Dermatologists

206 HK Malhi et al.
derived by steam distillation from the Australian plant Mel-
aleuca alternifolia (Myrtaceae). Tea tree oil has been used
medicinally in Australia since the 1920s and is currently
used primarily as a topical antimicrobial or anti-inflamma-
tory agent.6 Several previous studies have demonstrated
that tea tree oil products are beneficial for treating acne,
with fewer acne lesions present after therapy.7 Most previ-
ous trials have investigated products containing up to 5%
(v/v) tea tree oil but most of these products are not
available commercially. The aim of this study was there-
fore to evaluate the efficacy, tolerability and acceptability
of a commercially available tea tree oil gel (200 mg/g) for
the treatment of mild to moderate acne.
PARTICIPANTS AND METHODS
In vitro product evaluation
Clinical isolates of P. acnes (n = 10) were obtained from
PathWest Laboratory Medicine WA (Perth, WA, Australia).
Susceptibility to tea tree oil (non-formulated), Tea Tree
Medicated Gel for Acne (200 mg/g; AUST L 55740) and
Tea Tree Face Wash for Acne (7 mg/g), both supplied by
Thursday Plantation (Integria Healthcare, Brisbane, Qld,
Australia) was determined using a standard broth microdi-
lution method,8 with the exception that a brain-heart infu-
sion broth was used as the test medium. Products
contained Australian tea tree oil meeting the specifications
of the British Pharmacopoeia monograph for tea tree oil9
and both ISO 4730:2004 and Australian 2782–2009 stan-
dards for ‘Oil of Melaleuca, terpinen-4-ol type’ (tea tree
oil).10,11 Minimum inhibitory concentrations (MIC) of each
product were determined visually after 48 h of anaerobic
incubation and the assay was repeated in entirety thrice.
Pilot study design
This was a dual-centre, open-label, phase II pilot study
conducted at two sites in Perth, Western Australia and
approved by the Human Research Ethics Committees of
Royal Perth Hospital, Hollywood Private Hospital and the
University of Western Australia. The study was registered
with ClinicalTrials.gov (identifier NCT01657110) on 1
August 2012.
Participants
Participants were recruited from January to September
2014 by placing posters at both study sites, placing notices
in site newsletters and distributing the study notices to
staff and students at the university. Eligible participants
were of either sex, aged 14–45 years old, with mild to
moderate facial acne defined as 10–100 facial lesions, and
an investigator global assessment (IGA) score12 of at least
two and no more than two nodules. IGA scores were
defined as 0, clear skin with no lesions; 1, almost clear
with rare lesions; 2, mild severity with some non-inflam-
matory and no more than a few inflammatory lesions; 3,
moderate severity with many non-inflammatory and
some inflammatory lesions and 4, severe with many non-
© 2016 The Australasian College of Dermatologists
inflammatory and inflammatory lesions with no more than
a few nodules. Additional inclusion criteria were using
adequate contraception and the ability to provide
informed, written consent and comply with the study pro-
tocol. Exclusion criteria were a known allergy to tea tree
oil, another current skin disease, current use of steroids or
antibiotics, severe underlying disease, pregnancy, breast
feeding and having participated in another clinical trial
within the previous 12 weeks. Eligible participants pro-
vided their informed, written consent prior to inclusion.
For minors (under 18 years of age), informed written con-
sent was also obtained from the parent or legal guardian.
Intervention
The participants were allocated one 25 g tube of Tea Tree
Medicated Gel for Acne (200 mg/g; AUST L 55740) and
one bottle of Tea Tree Face Wash for Acne (7 mg/g), both
supplied by Thursday Plantation (Integria Healthcare). The
participants were instructed to self-patch test to confirm
the absence of a tea tree allergy by applying a pea-sized
amount of gel to the inner arm and leaving it on overnight.
If no reaction was seen, the participants continued with
the study. For treating facial acne, the participants were
instructed to use the products twice daily by firstly washing
their face with one pump of the face wash, patting it dry
and then applying a pea-sized amount of gel in a thin layer
to acne-affected areas. They were instructed to leave the
product on for at least 6 h and wash it off only at the next
application time. Additional products were supplied if
required.
Study assessments and outcomes
Efficacy and tolerability was clinically assessed by the
investigators at 4, 8 and 12 weeks. The participants were
also contacted at 2 weeks to check their progress and
protocol compliance. The primary efficacy end-points of
IGA score and total lesion count (including inflammatory
lesions, non-inflammatory lesions and nodules) were
recorded at each visit. The secondary efficacy end-point
of skin oiliness was also recorded by the investigator at
each visit using a five-point scale where 0 was none, 1
was minimal, 2 was mild, 3 was moderate and 4 was
severe. Study compliance and medication adherence were
assessed via a diary sheet on which the participants
recorded the time of day that they applied the products
and by the investigator weighing the products at each
visit. Participants were also asked to record at the end of
each week whether they thought their acne was signifi-
cantly worse, slightly worse, about the same, slightly
improved or significantly better.
The primary tolerability end-point was the frequency of
adverse events. The secondary tolerability end-point was
the mean local tolerability score, calculated as the mean of
scores assigned by the investigator to the five signs and
symptoms of erythema, scaling, peeling, induration and
dryness. These were scored on a five-point scale where 0
was none and 4 was severe. Any parameters graded as 4
 Tea tree oil products for acne treatment
Figure 1 Enrolment flow chart.
were classified as an adverse event. Product acceptability
was evaluated via a questionnaire completed by
participants at the final visit which had 10 questions cover-
ing product characteristics, usability and their overall
impression.
Statistical analyses
Data from the per protocol population (n = 14) were
analysed by a repeated measures ANOVA with a Bonferroni
post-test. The last observation carried forward method was
used to handle missing values. The level of significance
for all tests was set at 0.05.
Figure 2 Efficacy parameters of (a) mean numbers of lesions (standard error of the mean) and (b) investigator global assessment
(IGA) scores shown in a box-whisker plot. The boxes indicate the 25th–75th percentile, and whiskers indicate the maximum and minimum
values. The + symbol indicates the arithmetic mean and the heavy horizontal line indicates the median.
207
RESULTS
In vitro product evaluation
For tea tree oil, the MIC ranged from 0.25% to 1% (v/v);
90% of isolates having been inhibited by 1%. For the tea
tree oil gel, the MIC ranged from 0.31% to 2.5% (w/v) of
the product, corresponding to a tea tree oil concentration
range of 0.062–0.5%. The tea tree oil face wash inhibited
the growth of all isolates at <0.25% (v/v) of the product.
Participants’ disposition and baseline
characteristics
A total of 18 participants received the treatment (Fig. 1), of
whom 78% (n = 14) completed the study. Of these, five
were male and nine were female, with an age range of 16–
39 years, a mean of 26 years of age and a standard
deviation of 7 years. The participants had experienced
acne for an average of 11 years. Of the four (22%) partici-
pants who were discontinued, two did so for protocol
violations (commencement of new medications) and two
did so at the participants’ request.
Efficacy evaluation
The mean total lesion count was 23.7 (range 12–72) at
baseline, 17.2 at 4 (range 6–48), 15.1 at 8 (range 5–51) and
10.7 (range 1–23) at 12 weeks (Fig. 2a). The mean per-
centage decreases in total lesion count from baseline were
25% at 4, 37% at 8 and 54% at 12 weeks. Total lesion
counts at each visit differed significantly by a repeated
measures ANOVA (P < 0.0001). Post-hoc tests showed that the
total lesion counts differed significantly from baseline at 4
(P < 0.05), 8 (P < 0.01) and 12 weeks (P < 0.001).
The IGA score (Fig. 2b) decreased from a mean of 2.4 at
baseline to 2.2 at 4, 2.0 at 8 and 1.9 at 12 weeks. The
scores differed significantly from baseline at 8 (P < 0.05)
and 12 weeks (P < 0.05). The mean score for facial oiliness
© 2016 The Australasian College of Dermatologists
208
was 2.0 (mild) at baseline, 2.2 at 4, 1.6 at 8 and 1.1 at
12 weeks, which differed significantly by ANOVA
(P = 0.0004). Post-hoc tests showed that the change from
baseline was statistically significant at 12 weeks only
(P < 0.01). Clinical efficacy was defined in the protocol as
a reduction in total lesion count of 40% or more at
12 weeks. According this criterion, the products were clini-
cally effective in 11 (79%) participants.
Medication adherence data from diary sheets was
complete for all 12 weeks for 11 (79%) participants and
partially complete for the remainder. Overall, adherence
was high, with a mean application rate by participants of
96% (6.1%) and a range of 81–100%. The mean total
weight of gel used per participant was 27.7 g (range 4.9–
55.1 g). The total amount of gel used did not correlate with
total number of gel applications or baseline numbers of
acne lesions, suggesting that those who were 100% proto-
col compliant or those with the most severe acne were not
necessarily those who used the most gel. The mean weight
of the face wash used was 123.7 g (range 68.8–221.5 g).
At the end of each week, participants indicated on their
diary sheets their opinion on whether their acne severity
had changed compared with the previous week. The maxi-
mum possible number of responses from the per-protocol
population was 168 (14 participants multiplied by
12 weeks), and 132 responses (79%) were received. Of all
132 responses, the most frequent opinion expressed was
that their acne was ‘about the same’ (46%) compared with
the previous week, followed by ‘slightly improved’ (43%).
Figure 3 Mean tolerability scores for acne products containing tea tree oil applied to the face. Note that burning and induration were not
recorded at baseline as the products had not been used. Erythema, scaling and peeling differed significantly by ANOVA.
© 2016 The Australasian College of Dermatologists
HK Malhi et al.
The remaining responses were ‘slightly worse’ (8%), ‘sig-
nificantly worse’ (2%) and ‘significantly better’ (1%). Most
participants expressed their satisfaction that their numbers
of lesions had reduced during treatment and they did not
have expectations that their acne would be completely
gone at the end of the study.
Tolerability
No serious adverse events occurred. The highest score for
any tolerability parameter was 3 (moderate), recorded at
week 4 for three participants. One participant experienced
moderate scaling, one moderate peeling and one moder-
ate dryness. For the remaining weeks, scores ranged from
0 to 2. An additional participant reported a minor itch
within the first few days of applying the product. Overall
mean tolerability scores, calculated as the average of all
values recorded for all six tolerability indicators were 0.89
at baseline, 0.73 at 4, 0.40 at 8 and 0.29 at 12 weeks, indi-
cating that the treatment was well tolerated. Mean local
tolerability scores calculated for the six individual tolera-
bility parameters, as determined by the investigators at
baseline, 4, 8 and 12 weeks, are shown in Figure 3. Ery-
thema differed significantly from baseline at 8 and
12 weeks (P < 0.05) and peeling at 4 weeks differed
significantly from 12 weeks (P < 0.01). Scaling differed
significantly between weeks by ANOVA but post-hoc tests
were not significant. There were no other significant dif-
ferences.
 Tea tree oil products for acne treatment
Product acceptability evaluation
Product acceptability data was obtained from 15 partici-
pants, comprising 13 completed and two withdrawn partic-
ipants. The questions pertained only to the gel and not the
face wash. The highest score was 5 for strongly agree with
the statement and the lowest was 1 for strongly disagree.
Modal scores ranged from 3 to 5 and mean scores ranged
from 3.5 to 4.6, indicating that overall the gel was well
accepted. The lowest scores were for fragrance acceptabil-
ity and ease of absorption while the highest scores were
for texture, consistency and ease of application.
DISCUSSION
This pilot study showed that the use of a gel and face wash
containing Australian tea tree oil significantly reduced
numbers of acne lesions and was well tolerated. In addi-
tion, the products were highly acceptable to the partici-
pants. The efficacy may be due, in part, to antibacterial
activity, given that both products were active against P. ac-
nes in laboratory tests. It remains possible that study factors
such as the gel base product, or the regular, structured
facial care routine contributed to the improvement in acne.
A phase III placebo-controlled and double-blinded study
would be required to evaluate this possibility.
Most previous studies evaluating tea tree oil for treating
acne have assessed products containing 5% tea tree oil
applied for 4–8 weeks.13–16 In these studies mean reduc-
tions in total lesion counts ranged from 29% to 62%, with
an average across studies of approximately 45%.13–16 This
is similar to the current study, which found a mean reduc-
tion in total lesion count of 54% at 12 weeks. It is difficult
to compare this overall result with other topical treatments
such as benzoyl peroxide or antibiotic creams but an
evaluation of existing literature found comparable rates of
efficacy.17–20 For example, percentage changes in total
lesion counts found for benzoyl peroxide ranged from 36%
to 48%18,20 and for clindamycin gel ranged from 31% to
47%.17,21,22 However, the long-term use of antibiotics such
as clindamycin and erythromycin, either topically or orally,
is discouraged due to the development of resistance by
P. acnes23 and the potential spread of resistance determi-
nants to other bacteria. As a result of antimicrobial resis-
tance, the use of combination topical therapies, and of
non-antibiotic products such as tea tree oil, has become
highly relevant.
The products evaluated in the current study were well
tolerated, with no serious adverse events and only minor
local tolerability events. The rate of adverse events was
lower than in previous studies with tea tree oil products,7
although the gel contained a higher concentration than
those assessed previously. This may be due to differences
in criteria for adverse events between studies or due to
true differences between the tolerability of the products
evaluated.
A recent review of the efficacy and safety of tea tree oil
products for treating acne7 suggested that its efficacy is
attributable to the antimicrobial and anti-inflammatory
209
activity of tea tree oil. In theory, the antimicrobial activity
acts against P. acnes, which is found in acne lesions, and
the anti-inflammatory activity may inhibit both the inflam-
matory responses to P. acnes and the innate immune
responses that are found in acne-prone skin. Additional
mechanisms demonstrated for other acne treatment agents
such as decreasing sebum production and normalising
keratinisation have not been demonstrated for tea tree oil
thus far.
CONCLUSION
These data support previous findings that tea tree oil prod-
ucts reduce numbers of lesions and are well tolerated
when used for the treatment of mild to moderate facial
acne. Further double blinded, controlled trials are neces-
sary to thoroughly evaluate the efficacy and safety of tea
tree oil products in patients with acne.
ACKNOWLEDGEMENTS
The authors thank Thursday Plantation (Integria Health-
care (Australia) Pty Ltd) for providing the study products.
This study was supported Rural Industries Research and
Development Corporation (PRJ-006245).
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