Efficacy of Melaleuca alternifolia Essential Oil in the Treatment of Facial Seborrheic Dermatitis: A Double-blind, Randomized, Placebo-Controlled Clinical Trial

Abstract

Background: Melaleuca alternifolia (tea tree) essential oil has been traditionally used in the ayurvedic system of medicine for healing burns, infections and seborrheic dermatitis. But yet, no controlled human study has determined its efficacy. Objective: The goal of the current study was to compare the efficacy of 5% tea tree essential oil (TTO) gel with placebo in the treatment of mild to moderate facial seborrheic dermatitis. Methods: Fifty four patients with mild to moderate facial seborrheic dermatitis reffered to Skin Diseases Research Center, in the Qazvin city, Iran, were randomly divided into two groups and treated with either 5% TTO gel or placebo three times daily for 4 weeks. The patients follow-ups were conducted in both groups after 2 and 4 weeks with evaluating of erythema, scaling, itching and greasy crusts. Results: Forty two patients completed the treatment course. There were significant differences between the TTO and placebo groups in the improvement of erythema, scaling, itching and greasy crusts (p < 0.05). Allergic side - effects were seen in neither group. Conclusions: 5% TTO gel is effective in the treatment of mild to moderate facial seborrheic dermatitis.

Full text

Volume 13, No. 51, Summer 2014
Journal of Medicinal Plants
Efficacy of Melaleuca alternifolia Essential Oil in the Treatment of
Facial Seborrheic Dermatitis: A Double-blind, Randomized, Placebo-
Controlled Clinical Trial
Beheshti Roy A (Dermatologist.)1, Tavakoli-far B (Ph.D.)2*, Fallah Huseini H (Ph.D.)3, Tousi P
(M.D.)1, Shafigh N (M.D.)1, Rahimzadeh M (Ph.D.)4
1- Dermatology Department, Boali Hospital, Qazvin University of Medical
Science, Qazvin, Iran
2- Physiology and Pharmacology Department, Alborz University of Medical
Science, Karaj, Iran
3- Pharmacology & Applied Medicine Department of Medicinal Plants Research
Center, Institute of Medicinal Plants, ACECR, Karaj, Iran
4- Department of Social Determination of Health Research Center, Alborz
University of Medical Science, Karaj, Iran
* Corresponding author: Physiology & Pharmacology Department, Alborz
University of Medical Science, Karaj, Iran
Tel: +98-26-34336007
E mail: tavakkolifarb@yahoo.com
Received: 19 Aug. 2013 Accepted: 19 Aug. 2014
Abstract
Background: Melaleuca alternifolia (tea tree) essential oil has been traditionally used in the
ayurvedic system of medicine for healing burns, infections and seborrheic dermatitis. But yet, no
controlled human study has determined its efficacy.
Objective: The goal of the current study was to compare the efficacy of 5% tea tree essential oil
(TTO) gel with placebo in the treatment of mild to moderate facial seborrheic dermatitis.
Methods: Fifty four patients with mild to moderate facial seborrheic dermatitis reffered to Skin
Diseases Research Center, in the Qazvin city, Iran, were randomly divided into two groups and
treated with either 5% TTO gel or placebo three times daily for 4 weeks. The patients follow-ups
were conducted in both groups after 2 and 4 weeks with evaluating of erythema, scaling, itching
and greasy crusts.
Results: Forty two patients completed the treatment course. There were significant differences
between the TTO and placebo groups in the improvement of erythema, scaling, itching and
greasy crusts (p < 0.05). Allergic side - effects were seen in neither group.
Conclusions: 5% TTO gel is effective in the treatment of mild to moderate facial seborrheic
dermatitis.
Keywords: Melaleuca alternifolia, Facial seborrheic dermatitis, Tea tree oil gel, Topical
treatment
26

Efficacy of Melaleuca …
Introduction
Seborrheic dermatitis is a chronic,
relapsing, inflammatory skin disorder. The
prevalence of adult seborrheic dermatitis is
estimated to be between %2 and 5% [1]. The
symptoms of the disease include scaling,
erythema, itching and greasy crusts. Although
the exact cause of seborrheic dermatitis is yet
to be understood, Malassezia yeasts, hormones
(androgens), sebum levels and immune
response are known to play important roles in
its development. Additional factors, including
drugs, winter temperatures and stress may
exacerbate the disease [2].
An association is believed to exist between
malassezia yeasts and seborrheic dermatitis,
which may, in part be due to abnormal or
inflammatory immune response against these
yeasts [3].
Although topical antifungal agents such as
ketoconazole are used for treatment of
seborrehic dermatitis, but other treatment
modalities including low-potency topical
steroids and calcineurin inhibitors
(immunomodulators) are also used [4].
Tea tree oil (TTO) is essential oil from the
Melaleuca alternifolia tree, which is native to
Australia [5–7]. This oil has been traditionally
used for treatment of burns, infections and
seborrheic dermatitis [8,9]. However the
antibacterial, antifungal and anti-inflammatory
activities of TTO have been reported in several
experimental studies [10-13]. Recent studies
have revealed that TTO has antifungal activity
against Malassezia yeasts; it may thus be
beneficial in the treatment of seborrheic
dermatitis [3]. The goal of the present study is
to investigate the efficacy and tolerability of
5 % TTO gel in patients with mild to moderate
facial seborrheic dermatitis.
Materials and Methods
Drugs: TTO 5% and placebo gels (vehicle
hydroxypropyl cellulose) were provided by Dr.
Jahangir’s Company, Parmoon (Tehran, Iran).
The TTO and placebo gels were prepared with
same colour, texture and packing shape but
different labels. The composition of
M. alternifolia oil used in TTO gel is given by
Company is presented in table 1.
Inclusion criteria: Patients aged 18-45
years with mild-to-moderate facial seborrheic
dermatitis and no localized or systemic
infections.
Exclusion criteria: Compromised immune
system; definitive cutaneous findings such as
erythroderma, acne, psoriasis and known
allergy to lotions or moisturizers; pregnancy or
breastfeeding; use of products for seborrheic
dermatitis within the past 2 weeks or treatment
with systemic steroids and current treatment
with a medication that causes flushing.
Protocol: Fifty four patients meeting the
inclusion criteria who were referred to the
Skin Diseases Research Center of the
university-affiliated hospital in the Qazvin
city, Iran, from September 2013 to December
2013 were selected. The medical ethics
committee of the Skin Diseases Research
Center affiliated with Qazvin university
approved the protocol. Written informed
consent was obtained from all patients prior to
the study.
The study was double-blind and Block
randomization was used for treatment
allocation. Eighteen patients in each group was
the sample size calculated to estimate 25%
difference in total cure between the groups,
considering type I error = 0.05 and 80%
power. However 27 patients were selected in
each group for any loss during the study. The
CONSORT flowchart describing the progress
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Journal of Medicinal Plants, Volume 13,
No. 51, Summer 2014
Beheshti Roy et al.
Table 1- Composition of M. alternifolia (tea tree oil)
Component Composition (%)
T
yp
ical com
p
osition
Ter
p
inen-4-ol 41.1
γ
-Ter
p
inene 21.0
α-Ter
p
inene 11.4
1,8-Cineole 4.7
Ter
p
inolene 2.4
ρ
-C
y
mene 2.6
α-Pinene 1.9
α-Ter
p
ineol 3.1
Aromadendrene 1.7
δ-Cadinene 1.0
Limonene 0.9
Figure 1: CONSORT flowchart diagram
28

Efficacy of Melaleuca …
of the participants through the trial is shown in
Figure 1 . The patients and the investigators
who carried out clinical assessments were
unaware of treatment groups and type of
medication. The patients were instructed to
apply the TTO gel or placebo to the affected
facial areas three times daily. The severity of
seborrheic dermatitis was assessed in both
groups by a dermatologist at 2 and 4 weeks
following treatment initiation.
Skin involvement was assessed by a clinical
score based on the extent of itching, erythema,
scaling and greasy crusts as a primary
outcome. During the initial evaluation, the area
of involvement was measured using a scale of
1 to 5 representing ≤10%, 11% – 30%, 31% –
50%, 51% – 70% and >70% area involved,
respectively [14]. At the 2 and 4 weeks
following treatment initiation, assessment of
patient satisfaction was conducted by the
dermatologist as secondary outcome. A score
of <25% was assigned to a rating of very bad,
bad, no change or little improvement, 26% –
50% to mild improvement, 51% – 75% to
good improvement, 76% – 99% to major
improvement and 100% to total cure. The
patients were also questioned about any side
effects such as allergic irritation or
inflammation on each visit as secondary
outcome. For statistical analysis, t-test and
paired t- test were employed using SPSS
software. p<0.05 was considered as
statistically significant.
Results
The demographic characteristics of the
patients are shown in Table 2. Of the 54
patients enrolled in the study, 42 (77.7%)
completed the treatment course. 4 patients
from TTO and 8 from placebo groups failed to
attend the follow-up visits.
The scores of itching, erythema, scaling,
greasy crusts and scoring of patient
satisfaction are shown in Table 3. Statistically
significant decreases in the values of all
parameters were observed after 2 weeks of
treatment in the TTO group compared to the
placebo group (p< 0.05). After 4 weeks of
treatment, the values of all parameters in the
TTO group decreased significantly (p< 0.05),
compared with placebo group and compared
with baseline values, but it was reverse in the
placebo group after 2 or even 4 weeks of
treatment (p >0.05). Scoring of patient
satisfaction revealed total cure in 9 (39%) and
21 (91%) patients in the TTO group after 2
and 4 weeks of treatment, respectively. No
allergic irritation or inflammation due to
treatment was seen in both groups during the
study.
Table 2- The demographic characteristics of the patients in the TTO and placebo groups
Groups
TTO (N=23)
Mean±SD
Placebo (N=19)
Mean±SD
Age (year) 31 ± 10 28 ± 8
Disease duration (years) 3.0 ± 3.0 2.0 ± 2.2
Gender (male/female) 7 males, 16 females 6 males, 13 females
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Journal of Medicinal Plants, Volume 13,
No. 51, Summer 2014
Beheshti Roy et al.
Table 3- The itching, erythema, scaling, greasy crusts and patient satisfaction scores in TTO and placebo groups
in each visit
Baseline At 2 weeks At 4 weeks
Itching (%) TTO
Placebo
1.52 ± 0.79
1.7 ± 0.80
1.17 ±0.71
#
2.2 ± 1.2
0.64 ± 0.34*#
2.2 ± 1.0
Erythema (%) TTO
Placebo
1.65 ± 0.77
1.5 ± 0.62
1.47 ± 0.79#
2.4 ± 1.5*
0.69 ± 0.7*#
2.2 ± 1.6*
Scaling (%) TTO
Placebo
1.02 ± 0.82
1.1 ± 0.91
0.76 ± 0.31*#
1.8 ± 0.81*
0.55 ± 0.20*#
1.9 ± 0.90*
Greasy crust (%) TTO
Placebo
0.84 ± 0.22
0.7 ± 0.7
0.58 ±0.39
#
1.8 ± 0.5*
0.00 ± 0.00*#
1.8 ± 0.3*
Scoring of patient satisfaction (%) TTO
Placebo
0.00 ± 0.00
0.00 ± 0.00
39.3 ± 3.2*#
0.00 ± 0.00
91.5 ± 4.1*#
0.00 ± 0.00
*= p < 0.05 (compared to baseline)
♦= p < 0.05 (compared to placebo at the same time)
Discussion
In the current 4 weeks intervention study
the treatment of mild to moderate facial
seborrheic dermatitis with topical 5% TTO gel
reduced all the symptoms of facial seborrheic
dermatitis without any allergic reaction.
Although the numbers of patients in both
groups were not in satisfaction range but all
the patients in TTO group were satisfied of
treatment. The present finding is supported by
previous study which compared the
effectiveness of a cream containing 5% TTO
and 2 % butenafine hydrochloride in treatment
of toenail fungal infection [15]. In another
study, a cream containing 5% TTO was found
to reduce the symptom of tinea pedis as
effectively as 1% tolnaftate [16].
Although the exact mechanisms of TTO gel
in treatment of seborrheic dermatitis is
unknown, but several mechanisms may
proposed.
Although the exact cause of seborrheic
dermatitis has yet to be understood,
Malassezia yeasts, hormones (androgens),
sebum levels and immune response are known
to play important roles in its development [3].
Previous study has shown that topical and
systemic antifungal provide clinical benefit
[4]. The antifungal effect of TTO has been
reported in previous studies [15, 16]. The
antifungal effect of many medicinal plants are
attributed to their terpenoids content; however,
terpenoids are major component in TTO (table
1) that, may support the efficacy of TTO in
treatment seborrheic dermatitis [17,18].
Moreover seborrheic dermatitis is a chronic
inflammatory disease and anti-inflammatory
properties of TTO may be a factor in treatment
of seborrheic dermatitis [13,19]. Of note our
study had limitation such as small sample size,
short duration and lack of additional group
taking standard therapy. Considering the
current study finding and previous data
indicating TTO antifungal activity and its
efficacy in treatment of other chronic skin
disease such dandruff and acne [20, 21], TTO
can be used as an alternative therapy for
treatment seborrheic dermatitis if further large
scale and long-term clinical study approved it.
30

Efficacy of Melaleuca …
Conclusion
In conclusion, the TTO gel appeared to be
effective and well tolerated in the treatment of
mild to moderate facial seborrheic dermatitis
without any allergic reaction. Further large
sample size and longer duration study on TTO
gel comparing its efficacy to standard therapy
is suggested.
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