Complementary Therapies in Medicine 25 (2016) 159–163

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Complementary Therapies in Medicine

journal homepage: www.elsevierhealth.com/journals/ctim

Does supplementation with green tea extract improve acne in

post-adolescent women? A randomized, double-blind, and
placebo-controlled clinical trial夽
P.H Lu a,b , C.H. Hsu a,c,∗
a
Institute of Traditional Medicine, School of Medicine, National Yang-Ming University, Taiwan
b
Department of Dermatology, Far Eastern Memorial Hospital, Taiwan
c
Branch of Linsen and Chinese Medicine, Taipei City Hospital, Taiwan

a r t i c l e i n f o a b s t r a c t

Article history: Background: Green tea is believed to have beneficial effects in the prevention and treatment of acne.
Received 6 April 2015 Objective: To examine the effects of a decaffeinated green tea extract (GTE), providing a daily dose of
Received in revised form 4 March 2016 856 mg of epigallocatechin gallate (EGCG) upon women with post-adolescent acne.
Accepted 4 March 2016
Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted from May 2012
Available online 7 March 2016
through October 2013. A final group of 80 subjects were randomly assigned to receive either 1500 mg of
decaffeinated GTE or placebo (cellulose) daily for 4 weeks. Inflammatory lesion counts were used as the
Keywords:
major outcome measurement. At baseline and after 4 weeks of treatment, anthropometric measurements,
Acne vulgaris
Epigallocatechin-3-gallate
fasting glucose levels and a lipid profile were measured from both groups.
Green tea extract Results: Sixty-four of 80 women, from 25 to 45 years of age with moderate-to-severe acne completed
Post-adolescent the study. Statistically significant differences were noted in inflammatory lesion counts distributed on
the nose, periorally and on the chin between the two groups. However, there were no significant dif-
ferences between groups for total lesion counts. Within-group comparison revealed that the GTE group
had significant reductions in inflammatory lesions distributed on the forehead and cheek, and significant
reductions in total lesion counts. GTE resulted in significant reductions in total cholesterol levels within
the GTE group.
Conclusions: GTE resulted in significant reductions in lesions located on the nose, perioral area and chin.
More research is required to determine whether a decaffeinated GTE standardized for EGCG content will
provide clinical benefits in women with post-adolescent acne.
© 2016 Elsevier Ltd. All rights reserved.

1. Introduction Epigallocatechin-3-gallate (EGCG), the major polyphenol in

A subset of adult women have acne primarily involving the
face, and many have unsuccessfully undergone standard acne
treatments.1 During the past decade, four major pathological
processes have been found to play a critical role in the devel-
opment of adult-onset acne: (1) increased sebum production by
the sebaceous glands, (2) altered keratinization of follicular ker-
atinocytes, (3) activity of Propionibacterium acnes (P. acnes), and (4)
inflammation.2–4
green tea, has potent anticarcinogenic, anti-inflammatory, and
antimicrobial activities.5–7 EGCG can modulate several key patho-
logical factors of acne, including hyperseborrhea, lipogenesis,
inflammation, and P. acnes overgrowth.8–11 The efficacy of a lotion
made with green tea extract was recently reported in clinical trials
of acne patients.11–14
These observations led us to hypothesize that EGCG may be ben-
eficial in women with post-adolescent acne. Therefore, we provide
a daily dose of 856 mg of epigallocatechin gallate (EGCG) to exam-
ine the effects of a decaffeinated green tea extract (GTE) on women
with post-adolescent acne.

夽 The trial was conducted at Branch of Linsen and Chinese Medicine, Taipei City
Hospital; address: No. 145, Zhengzhou Rd., Datong Dist., Taipei, Taiwan.
∗ Corresponding author at: Institute of Traditional Medicine, National Yang-Ming
University, No. 155, Li-Nong St, Sec. 2, Peitou, Taipei, Taiwan.
E-mail address: owlherbs@yahoo.com.tw (C.H. Hsu).

http://dx.doi.org/10.1016/j.ctim.2016.03.004
0965-2299/© 2016 Elsevier Ltd. All rights reserved.

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2. Materials and methods Table 1

Components of decaffeinated GTE capsules and daily dose (in mg).

2.1. Study design and participants Components % in Weight Daily dose (in Per capsule (in
mg) mg)
The trial was conducted from May 2012 through October 2013 EGCG (Epigallocatechin gallate) 57.12 856.8 285.6
at Taipei Hospital, Taiwan. A final group of 118 subjects met ECG (Epicatechin gallate) 15.74 236.1 78.7
the inclusion-exclusion criteria. Enrolled subjects included women EGC (Epigallocatechin) 7.70 115.5 38.5
EC (Epicatechin) 4.80 71.9 24
between 25 and 45 years of age, with moderate or severe acne vul-
GCG (Gallocatechin gallate) 4.25 63.7 21.25
garis as defined by the Investigator’s Global Assessment (IGA; score GC (Gallocatechin) <0.07 <1.05 <0.3
of 3 or 4 on a scale from 0 to 5).15 None of the women had received Caffeine <0.07 <1.05 <0.3
systemic retinoid or hormone treatment during the previous 3 Cellulose 10.33 155.0 51.65
months. Subjects with systemic illness or dermatologic conditions
that could interfere with treatment or evaluation were excluded
from the trial. A total of 80 subjects enrolled in the study after pro- from dried leaves of green tea according to pre-set standard
viding written informed consent. The study protocol was approved procedures, and was verified with a certificate of analysis. The
by the Human Ethics Committee of Taipei Hospital. Patients were decaffeinated GTE used in this study was standardized for sev-
randomly allocated to receive a decaffeinated GTE (Group A) or a eral tea catechins in addition to EGCG (Table 1). The placebo was
placebo (cellulose; Group B) for four weeks (Fig. 1). comprised of pure microcrystalline cellulose. Capsules contained
either 500 mg decaffeinated GTE extract or cellulose. The subjects
were asked to take 1 capsule 30 min after meals 3 times daily for
2.2. Randomization and blinding 4 weeks. The total daily dosage of tea compounds received by the
GTE treatment group is listed in Table 1.
Subjects were randomized in a 1:1 ratio by a designated
assistant (using a computed randomization list that generated
2.4. Outcome measurements
treatment numbers in two groups) to receive either decaffeinated
GTE or placebo. The randomization list and the electronic file
Lesion counts were recorded by a blinded dermatologist for
were kept in a locked cabinet and in an electronic file with access
the entire face by counting each inflammatory lesion (papules,
restricted access to the designated personnel directly responsible
pustules, nodules, and cysts) and non-inflammatory lesion (come-
for labelling and handling the study medications. These precautions
dones). Because we specified patient group by IGA score,15 so the
were followed until the study database was locked and ready to be
main outcome measure was the acne lesion counts.
unblinded for statistical analyses. The investigators could not gain
At baseline and after 4 weeks of treatment, the following were
access to the randomization list, and the integrity of the blinding
assessed for both groups: body mass index (BMI, body weight in
was ensured by packaging the product in identical opaque capsules
kilograms divided by height in meters squared, or kg/m2 ), blood
and requiring a research assistant blinded to the product contents
pressure (BP, mm Hg), waist circumference (WC), and hip circum-
to dispense the capsules.
ference (HC). In addition, fasting glucose, triglycerides, high- and
low-density cholesterol (HDL and LDL) levels were measured for
2.3. Preparation of samples and treatment both groups. In addition, the subject’s quality of life was assessed
using a Cardiff Acne Disability Index (CADI) questionnaire admin-
Decaffeinated GTE was obtained from the Tea Research and istered at each visit. The secondary outcome were lipid profile,16,17
Extension Station, Taoyuan County, Taiwan. The GTE was extracted including triglycerides, total cholesterol, high- and low-density

Fig. 1. Study Flow Diaphragm.

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 P.H Lu, C.H. Hsu / Complementary Therapies in Medicine 25 (2016) 159–163 161

Table 2
Baseline Characteristics of Participants.

Decaffeinated GTE (n = 33) Placebo (cellulose) (n = 31) p-Value

Family history, yes (%) 33.3% 31.0% 1.00

Age (years) 28.0 ± 10.0 30.2 ± 7.7 0.35
Time since diagnosis of acne (years) 7.8 ± 7.9 4.3 ± 4.6 0.18
Height (cm) 159.2 ± 4.9 158.2 ± 4.8 0.43
Body weight (kg) 52.5 ± 8.2 55.9 ± 11.5 0.19
Body mass index (kg/m2) 20.7 ± 2.9 21.7 ± 5.8 0.39
Waist (cm) 73.6 ± 7.9 76.4 ± 8.0 0.16

Waist/Hip 0.8 ± 0.1 0.8 ± 0.0 0.75

Acne lesion counts Inflammatory 28.2 ± 14.5 28.7 ± 12.7 0.18
Non-inflammatory 6.5 ± 3.1 6.2 ± 2.6 0.72
total 34.7 ± 16.1 35.2 ± 14.8 0.90

Data expressed as a mean with standard deviation.

Table 3
Acne lesion counts, demographic and biochemical characteristics of participants at baseline and after 4 weeks.

Decaffeinated EGCG (n = 33) Placebo (cellulose) (n = 31)

Variables Baseline After 4 weeks p-value Baseline After 4 weeks p-value Post-treatment p-value

Basic data
Body Weight (kg) 52.5 ± 8.2 52.2 ± 8.1 0.33 55.9 ± 11.5 55.8 ± 11.8 0.88 0.15
SBPa (mmHg) 111.2 ± 14.2 111.9 ± 13.2 0.66 116.4 ± 15.5 113.9 ± 15.9 0.24 0.61
DBPb (mmHg) 67.5 ± 11.9 67.3 ± 11.9 0.87 68.7 ± 10.5 69.8 ± 12.3 0.32 0.47
Heart Rate (bpm) 79.7 ± 8.3 77.5 ± 8.9 0.12 79.0 ± 10.0 75.8 ± 11.0 0.09 0.56

Fasting serum factors

Fasting blood sugar (mg/dL) 89.8 ± 18.6 87.0 ± 16.4 0.10 85.3 ± 7.9 85.9 ± 7.9 0.70 0.76
ALTc (IU/L) 21.5 ± 7.9 22.3 ± 7.9 0.32 25.3 ± 25.4 38.9 ± 61.2 0.17 0.13
Creatinine (mg/dL) 0.7 ± 0.1 0.7 ± 0.1 0.66 0.7 ± 0.1 0.7 ± 0.1 0.75 0.89
Triglyceride (mg/dL) 88.7 ± 29.5 80.2 ± 57.6 0.37 94.9 ± 58.0 92.8 ± 46.4 0.81 0.34
Total cholesterol (mg/dL) 174.5 ± 30.4 163.8 ± 30.2 0.003* 173.9 ± 19.0 174.1 ± 21.0 0.95 0.18
LDL-Cd (mg/dL) 93.9 ± 22.5 90.3 ± 24.3 0.27 97.0 ± 15.5 96.8 ± 16.4 0.94 0.31
HDL-Ce (mg/dL) 57.6 ± 10.2 57.7 ± 12.4 0.95 55.8 ± 10.5 56.3 ± 9.6 0.71 0.58

Acne lesion counts

Inflammatory
Forehead 6.5 ± 4.4 5.4 ± 3.5 0.04* 4.6 ± 2.8 5.0 ± 3.6 0.40 0.68
Cheek 15.8 ± 11.0 14.5 ± 9.7 0.04* 15.3 ± 10.2 13.7 ± 10.2 0.01* 0.76
Nose 1.2 ± 1.2 1.0 ± 0.8 0.08 1.5 ± 1.2 1.5 ± 1.2 0.84 0.03*
Perioral area 2.0 ± 1.8 1.7 ± 1.3 0.05 3.0 ± 2.2 2.7 ± 1.9 0.08 0.04*
Chin 2.7 ± 2.4 2.3 ± 1.8 0.05 4.3 ± 4.1 3.7 ± 3.4 0.01* 0.03*
Whole face 28.2 ± 14.5 24.8 ± 17.7 0.003* 28.7 ± 12.7 26.7 ± 13.0 0.02* 0.88
Non-inflammatory 6.5 ± 3.1 6.5 ± 2.7 0.48 6.2 ± 2.6 6.0 ± 2.2 0.44 0.41
Total 34.7 ± 16.1 33.8 ± 18.6 0.46 35.2 ± 14.8 32.7 ± 14.0 0.66 0.80
Cardiff Acne Disability Index (CADI) 5.5 ± 2.7 4.7 ± 2.8 0.28 6.3 ± 2.7 4.9 ± 3.1 0.80 0.83

Data expressed as a mean with standard deviation.

*
p < 0.05.
a
SBP—systolic blood pressure.
b
DBP—diastolic blood pressure.
c
ALT—alanine transaminase.
d
LDL-C—low density lipoprotein cholesterol.
e
HDL-C—high density lipoprotein cholesterol.

cholesterol (HDL and LDL) levels. Safety was assessed through eval- Allowing for a 20% dropout, 80 patients would be needed in this
uations of the incidence of adverse effects and facial discomfort study.
tolerability at the last visit.

2.5. Statistical analysis 3. Results

The data were analyzed using SPSS software (version 17.0). Inde-
pendent t-tests were employed to examine the difference in the
main outcomes, anthropometrics, biochemical characteristics, and
life-quality scores between EGCG group and placebo group. Paired
t-tests were utilized to examine within-group differences at base-
line and again at 4 weeks. All p-values were two-tailed, and the
level of significance was set at 0.05. Our own experience suggested
a standard deviation (SD) of 5.5 and a mean acne lesion count of
28 in a previous series of 10 patients with acne. It was calculated
that to detect a difference in acne lesion counts with a significance
level of 0.05 and a power of 0.8, that 64 patients would be required.
3.1. Demographics and measurements at baseline
At our outpatient clinic 366 women were screened, and 118 sub-
jects who met the inclusion criteria were invited to participate.
22 subjects were excluded by the exclusion criteria while 16 sub-
jects refused to participate due to failure to attend study visits. 80
subjects enrolled in the study were allocated equally into groups
A (GTE treatment) and B (placebo). Sixty-four patients completed
the study (Fig. 1). To monitor the compliance, subjects were asked
about the number of unused capsules. Seven subjects from Group
A and 9 subjects from Group B dropped out of the study. The main

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 162 P.H Lu, C.H. Hsu / Complementary Therapies in Medicine 25 (2016) 159–163
reason for study discontinuation in both groups was given as “lost
to follow-up.”
Baseline demographics and measurements including age, fam-
ily history, and years since being diagnosed with acne and weight,
height, BMI, waist circumference, and hip circumference showed no
significant difference between the two groups (Table 2). The two
groups also had comparable numbers of acne lesions at baseline
(Table 2).
3.2. Between-group comparisons at 4 weeks
As shown in Table 3, there were statistically significant dif-
ferences in inflammatory lesion counts of the nose, perioral area,
and chin. The GTE group had no significant reduction in forehead,
cheek and total lesion counts. Between-group differences for BMI,
body weight, WC, waist-to-hip ratio, blood pressure, fasting glu-
cose, alanine aminotransferase (ALT), creatinine, total glucose, total
cholesterol, LDL, HDL, and quality of life all failed to reach statistical
significance (Table 3).
3.3. Within-group comparisons at 4 weeks
Compared with baseline measurements, 4 weeks of treat-
ment with decaffeinated GTE resulted in significant differences in
the number of inflammatory lesions distributed on the forehead,
cheeks and entire face (Table 3). We also found significant differ-
ences in the number of inflammatory lesions located on the cheeks,
chin, and entire face in the placebo group. There was a significant
decrease in total inflammatory lesion counts among the women in
both the treatment and placebo groups. In addition, GTE resulted
in significant reductions in total cholesterol levels within the GTE
group, but not in the placebo group.
3.4. Safety evaluation
No subjects withdrew from the study because of discomfort or
adverse effects associated with the treatment. One subjects devel-
oped mild constipation and two others had abdominal discomfort
after GTE treatment. Among those in the cellulose treatment group,
one subject reported feeling thirsty and another had difficulty
falling asleep. No facial discomfort was reported, and no major
adverse effects were noted.
4. Discussion
To our knowledge, this is the first study to explore the effect of
oral decaffeinated GTE on women with post-adolescent acne. Some
human study demonstrates that EGCG is effective in acne lesions,
with only a few mild side effects. However, most of these studies
were not double-blinded or randomized, had no control group, and
included small sample sizes.11–14
The GTE group had a significant reduction in the forehead, cheek
and total lesion counts after 4 weeks of treatment. GTE resulted in
significant reductions in the number of lesions located on the nose,
perioral area, and chin, but not in the total number of lesions in
each of the two groups.
There were some differences between our study and previous
human studies. First, in our study, patients took oral GTE for 4
weeks, but a longer course may be needed to reduce the total num-
ber of acne lesions. Researchers in previous studies have applied
topical EGCG for a longer period.11–14 Second, topical treatment on
the face may work more directly on the follicles, compared with
oral supplementation. This may explain the discrepancies between
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our study and previous human studies with topical EGCG. In mild
acne, we may use topical treatment only, but for patients with mod-
erate to severe acne, oral treatment is added.18 In contrast to the
studies where subjects with mild-to-moderate acne were treated
with topical application of EGCG11–14 ; in our study, women with
moderate-to-severe acne took oral GTE. Third, the mean age of
women with post-adolescent acne in our study was greater than
that of women in previous studies. Even with systemic antibiotics,
treatment failures occur in 80% of adult women.1 As for the limita-
tion of this study, the small sample size and the large variance of the
acne lesion counts made some outcomes non-significant. Besides,
the compliance was monitored only by the number of unused cap-
sules. We did not measure the bioavailability of EGCG. It has been
reported system availability of EGCG increases more than 60% after
a high daily dose of EGCG for 4 weeks.19 Although the daily EGCG
intake was similar in our study (864 mg), it was divided to three
doses per day. Further research on the optimum EGCG dosage and
frequency for acne control is needed.
GTE resulted in significant reductions in total cholesterol lev-
els within the GTE group. Studies have shown that GTE decreased
plasma levels of LDL-cholesterol and triglycerides and increased the
level of HDL-cholesterol in animal models16 and in obese women.17
Despite our considerations of the potential anti-acne role of
EGCG, there remain several major challenges in interpreting the
clinical relevance of our data. More studies are needed to clar-
ify two major questions: (1) why did both the decaffeinated GTE
and placebo groups have significant within-group differences in
total inflammatory lesion counts? And (2) does GTE improve total
inflammatory lesion counts in women with moderate-to-severe
post-adolescent acne? The results of several current studies sup-
port the need for further studies for clinical application of EGCG in
acne patients.11–13
5. Conclusion
GTE resulted in significant reductions in the number of lesions
located on the nose, perioral area, and chin between the two groups.
Further studies will be needed to demonstrate whether EGCG will
be a treatment for women with post-adolescent acne.
Conflicts of interest
We wish to confirm that there are no known conflicts of interest
associated with this publication and there has been no significant
financial support for this work that could have influenced its out-
come.
We confirm that the manuscript has been read and approved by
all named authors and that there are no other persons who satisfied
the criteria for authorship but are not listed. We further confirm
that the order of authors listed in the manuscript has been approved
by all of us.
We confirm that we have given due consideration to the pro-
tection of intellectual property associated with this work and that
there are no impediments to publication, including the timing of
publication, with respect to intellectual property. In so doing we
confirm that we have followed the regulations of our institutions
concerning intellectual property.
We further confirm that any aspect of the work covered in
this manuscript that has involved either experimental animals or
human patients has been conducted with the ethical approval of all
relevant bodies and that such approvals are acknowledged within
the manuscript.
 P.H Lu, C.H. Hsu / Complementary Therapies in Medicine 25 (2016) 159–163
We understand that the corresponding author is the sole contact
for the Editorial process (including Editorial Manager and direct
communications with the office). He is responsible for commu-
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the Corresponding Author and which has been configured to accept
email from
Signed by all authors as follows:
Po-Hsuan Lu
Chung-Hua Hsu
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