Journal of Dermatological Treatment.

2010; 21:201–205

ORIGINAL ARTICLE

A study of the efficacy of cleansers for acne vulgaris

YU SUNG CHOI1, HO SEOK SUH1, MI YOUNG YOON2, SEONG UK MIN2,3,

JIN SOOK KIM2, JAE YOON JUNG2,3, DONG HUN LEE3 & DAE HUN SUH2,3
J Dermatolog Treat Downloaded from informahealthcare.com by University of S.A Lib 119257 on 11/07/12

1
Department of Dermatology, Ulsan University Hospital, Ulsan, Korea, 2Acne Research Laboratory, Seoul National
University Hospital, Seoul, Korea and 3Department of Dermatology, Seoul National University College of Medicine,
Seoul, Korea

Abstract
Background: Acne treatments are sometimes expensive, and mild acne patients need some simpler form of treatment and, thus,
the need for easier and cheaper ways of managing acne is increasing. Methods: An 8-week, double-blind, randomized clinical
trial was conducted to determine whether cleansers are effective at producing clinical improvements in patients with acne
vulgaris. A total of 13 acne patients applied cleanser A to one half of the face and cleanser B (cleanser A plus triclosan, salicylic
For personal use only.

acid, and azelaic acid) to the other half, twice daily. Results: The numbers of inflammatory and non-inflammatory lesions
decreased on both sides. A rebound tendency was noted for cleanser A with respect to inflammatory lesions at 4 weeks post-
discontinuation, whereas inflammatory lesions continued to decrease on sides treated with cleanser B during this period.
However, non-inflammatory lesion counts were not significantly different in the two groups. Though patients were generally
satisfied with both treatments, they were more satisfied with cleanser B. Moreover, histopathologic examinations showed a
profound decrease in inflammatory reactions in the cleanser B group. Conclusion: These results show that acne cleansers
reduced both inflammatory and non-inflammatory acne lesion counts, and might be helpful for acne treatment.

Key words: acne, acne treatment, cleanser

Introduction studies have described beneficial effects for special

Acne is a common dermatologic condition that can
cause severe inflammation and scarring, which arises
as a sequela of inflammation and is usually difficult
to treat. The pathogenesis of acne includes four
primary processes: hyperkeratinization of pilosebac-
eous follicles, increased sebum production, increased
Propionibacterium acnes colonization, and inflamma-
tion (1,2). No single topical agent has yet been devel-
oped that addresses all of these factors, hence
combination regimes have become the mainstay of
treatment. However, these are usually costly and
might have adverse side effects. Recently, interest
in acne treatments involving the modification of daily
activities, such as facial washing, has increased and
facial cleansers (3–5). These products usually include
alpha hydroxy acid, salicylic acid, and benzoyl per-
oxide, which are the components of topical acne
treatments, and, thus, conceptually they should be
at least partially beneficial (6,7). Although it is
believed that good skin care involving daily cleansing
also helps acne improvement, the effectiveness of
specialized acne cleansers remains inconclusive (8).
Moreover, histopathologic evaluations following the
use of special daily cleansers have been limited so far.
Therefore, in the present study, we evaluated the
efficacy and safety of an acne cleanser incorporating
0.04% triclosan, 1% salicylic acid, and 1% azelaic
acid, and associated histopathologic changes in mild
acne vulgaris patients.

Correspondence: Dae Hun Suh, Department of Dermatology, Seoul National University Hospital, 28 Yongon-dong, Chongno-gu, Seoul, Korea.
Fax: 82 2 742 7344. E-mail: daehun@snu.ac.kr

(Received 26 May 2009; accepted 27 September 2009)

ISSN 0954-6634 print/ISSN 1471-1753 online
2010 Informa UK Ltd.
DOI: 10.3109/09546630903401454
 202 Y. S. Choi et al.
Materials and methods
This 8-week study was a split-face, double-blind,
randomized controlled study, and was approved by
the institutional review board of Seoul National Uni-
versity Hospital. All subjects provided written
informed consent. Thirteen patients, aged 20–37 years
with mild facial acne grades of 0.25 to 2 according to
Cunliffe’s grading system (2), but who were otherwise
healthy, were recruited. The distribution of acne was
relatively symmetric. The use of other facial treatment
was not permitted during the study, and all acne
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medications were stopped 6 weeks prior to the study.
At initial visits, the sides of patients’ faces were
randomly assigned to cleanser A or B, and patients
were provided with appropriately labeled cleansers.
The main components of cleanser A were papain,
proteomax and soap powder, and of cleanser B were
0.04% triclosan, 1% salicylic acid, and 1% azelaic acid
in addition to the other constituents of cleanser A. Both
cleansers were made by NanoPharm Corporation
(Seoul, Korea). Patients were asked to use each cleanser
for 4 weeks twice daily (morning and evening) and notto
use these cleaners during the following 4 weeks.
For personal use only.
Patients were evaluated over the course of the 8-week
study period (atotal of four visits:a pretreatmentbaseline
visit, follow-up visits after 2 and 4 weeks, and a final visit
at 8 weeks). Facial photographs were taken at each visit.
The following clinical evaluations were performed: (i)
Cleanser A, before use Cleanser A, at the 4th week
Cleanser B, before use Cleanser B, at the 4th week
Figure 1. Clinical photographs of a 29-year-old male case. Clinical improvements were observed for cleansers A & B. After discontinuing
cleanser use, inflammatory lesions increased in the cleanser A side.
acne lesion counts (inflammatory and non-inflamma-
tory); (ii) overall rating of acne severity using the
Cunliffe’s grading system (2); (iii) rating of patient
satisfaction, ranging from 0 (not satisfied) to 10 (very
satisfied) at weeks 2, 4 and 8; and (iv) assessment of skin
irritations (i.e. dryness, erythema, edema, scaling, and
tightness). At the initial and final visits, a skin biopsy was
performed on a representative acne lesion on each cheek.
Routine H&E and immunohistochemical staining for
TGF-b were done. TGF-b was regarded as an anti-
inflammatory cytokine, and has recently been suggested
to participate in the resolution of inflammatory acne (9).
For H&Estaining,the severityofinflammationwas rated
from 0 (no inflammation) to 4 (severe inflammation);
and in terms of TGF-b, staining intensity was rated from
0 (not stained) to 4 (intensively stained).
Statistical analysis was performed using the SPSS
statistical package. Clinical and histopathologic data
obtained from both sides of the face at each visit were
analyzed using the Wilcoxon signed rank test. Signif-
icance levels were set at p-values less than 0.05.
Results
All 13 patients completed the study (six males and
seven females; between the ages of 20 and 37 years:
average 26 years). Representative photographs are
shown in Figure 1.
Cleanser A, at the 8th week
Cleanser B, at the 8th week

A.
Inflammatory acne lesion counts
100
† †
80
(% of baseline)
60
40
20
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0 0
0 wk 2 wk
Figure 2. (A) Inflammatory and (B) non-inflammatory acne lesion counts in the two groups versus time. Error bars represent mean ± standard
error of the mean. †p < 0.05, compared to baseline; *p < 0.05, between cleanser A and B.
The lesion counts of inflammatory acne decreased
following the use of both cleansers (Figure 2A). For
cleanser A, at 4 weeks after commencement, they had
reduced significantly to 42% of baseline. However,
after discontinuation (week 8), these counts
rebounded to 53% of baseline. For cleanser B, the
For personal use only.
number of inflammatory lesions also decreased after
commencement to 46% of baseline at 4 weeks. Unlike
cleanser A, these counts continued to decrease after
discontinuation, and at 8 weeks were 13% of baseline,
showing a significant difference between cleansers A
and B at week 8.
Figure 2B shows the percentage changes in the
number of non-inflammatory lesions over time. For
cleanser A, the number of non-inflammatory lesions
decreased after commencement, and at 4 weeks
had significantly reduced to 44% of baseline. After
discontinuation, these counts rebounded to 62%
of baseline. For cleanser B, the number of non-
inflammatory lesions also decreased after commence-
ment and at 4 weeks the number was significantly
reduced to 50% of baseline. After discontinuation,
cleanser B showed slightly less rebound than
cleanser A, but this was not significant.
Initial acne grades in cleanser groups A and B were
1.6 and 1.5, respectively, and after 2, 4 and 8 weeks
they were 1.3, 1.2 and 1.4, respectively, in both
groups. Although these differences were not signifi-
cant, the use of both cleansers tended to reduce
acne grades.
At every visit, patients were asked whether they
were satisfied with the treatment results. For
cleanser A, patient satisfaction increased from 0
(baseline) to 1.4 (week 2), 2.4 (week 4), and 2.9
(week 8); for cleanser B the corresponding figures
were 1.4, 2.5, and 4.0 (Figure 3). The degree of
patient satisfaction was found to increase in
Efficacy of cleansers for acne vulgaris 203
B.
Cleanser A Cleanser A
Non-inflammatory acne lesion counts
Cleanser B 100 Cleanser B
†
80
†
(% of baseline)
*
†
† 60 †
†
† †
†
40
† 20
4 wk 8 wk 0 wk 2 wk 4 wk 8 wk
proportion to duration of cleanser use, and
cleanser B had a significantly higher satisfaction score
at week 8 than cleanser A.
Histopathologic evaluation revealed that at baseline
the intensity of inflammation was 2.0 in both groups,
but at week 8 it was 1.9 and 1.4 for cleanser A and B,
respectively, which was a significant improvement in
the latter group. Immunohistochemical staining for
TGF-b showed an intensity of 2.4 at baseline in both
groups, and of 3 at week 8 in the cleanser A group and
3.4 in the cleanser B group, albeit not significant in
either group.
No significant adverse events, such as xerosis,
scales, or pruritus, were recorded after using either
cleanser. One patient reported transient erythema for
cleanser A, but this disappeared after a few hours.
Three patients reported a decrease in sebum produc-
tion but this was not objectively measured.
Discussion
The relationship between facial washing and acne
has not been clearly established. Acne patients usu-
ally believe that a lack of skin care and facial dirt
aggravate acne, while in the past, dermatologists
used to believe that excessive facial washing exacer-
bates acne and weakens the skin barrier function (4).
However, in recent reports, skin barrier functions
were not found to be disrupted after facial washing,
which contradicts previously held opinions. Moreover,
excessive facial washing proved not to be a cause of
acne (8).
Some cleansers contain low concentrations of top-
ical agents that are used to treat acne, or natural
products that supposedly ameliorate acne. In the
present study, cleanser B contained triclosan, salicylic
 204 Y. S. Choi et al.
10
9 Cleanser A
Patients satisfaction scores
8 Cleanser B
7
6 *
5 †
4 that the two cleansers caused clinical improvements to
†
3 † † a smaller degree as compared with other topical acne
2 † †
1 inflammation based on H&E findings in both cleanser
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0 groups, though this was more profound in the
0 wk 2 wk 4 wk 8 wk
Figure 3. Comparison of subjective assessments. Error bars rep-
resent mean ± standard error of the mean. †p < 0.05, compared to
baseline. *p < 0.05, between cleanser A and B.
acid, and azelaic acid. Triclosan, otherwise known as
5-chloro-2-(2, 4-dichlorophenoxy) phenol, is a bac-
tericidal agent with activity against various gram pos-
itive and gram negative organisms (10). Salicylic acid
has keratolytic, comedolytic, and anti-inflammatory
For personal use only.
effects, and, thus, is effective at treating both inflam-
matory and non-inflammatory acne lesions (6,11–14).
Finally, azelaic acid has bactericidal, a weak come-
dolytic, and anti-inflammatory effects (15).
Because lesion counts decreased in both groups,
we consider that this might be due to common
components such as papain and proteomax, which
might inhibit microcomedone formation, and, thus,
non-inflammatory lesions. However, in the case of
inflammatory lesions, cleanser B, but not cleanser A,
caused lesion counts to decrease during and after use.
We consider that this sustained effect of cleanser B
is probably associated with the effects of salicylic and
azelaic acids because both have a comedolytic effect
which inhibits the formation of a comedone in its
early stage.
The reasons why inflammatory and non-
inflammatory acne lesion counts reduced in the
cleanser A group are not obvious, but we propose
the following. Both cleansers contained enzymatic
components (i.e. papain and proteomax), which
might have participated in the degradation of desmo-
somes, and thereby promoted desquamation and ulti-
mately reduced comedone formation (16). These
components were not thought to be related to the
sustained effect, accounting for a rebound tendency
in acne lesion counts in cleanser A. The observation
of sustained improvement in the cleanser B group
is probably related to the presence of triclosan, sal-
icylic acid and azelaic acid. It is not known which
of these is predominantly responsible, and generally
commercial products contain mixtures of triclosan,
benzoyl peroxide, alpha hydroxyl acid, salicylic acid,
and/or others (15,17–19).
No significant difference in acne severity grade was
observed between the two groups during the whole
study period, which might be related to the low initial
acne grades of the cohort. Moreover, it is also possible
medications.
Histopathologic examinations showed decreases in
cleanser B group. We attribute this finding to the
presence of salicylic acid and azelaic acid in
cleanser B. Although no significant differences were
found between H&E findings, the decrease of inflam-
matory lesions induced by cleanser A supports the
notion that daily facial washing can reduce acne. The
role of TGF-b in acne lesions is unclear, but it has
been regarded to be related to the resolution of
inflammation, the regulation of cellular and humoral
immunity, and the inhibition of keratinocyte prolif-
eration (9). In the present study, the stain intensity of
TGF-b became stronger after the use of cleansers and
it was more intense in the cleanser B group, although
there was no statistical difference between the two
study groups. Thus, we cautiously consider a possi-
bility that improvements achieved by the use of a
cleanser might be related to TGF-b induction.
From our study, cleansers containing components
that are active against acne are believed to be effective,
especially against inflammatory acne lesions.
Although the present study was based on a relatively
small sample size, we believe that our statistical find-
ings are valid and there was no drop-out during the
study. The clinical improvements induced by acne
cleansers appeared within 2 weeks, and these were
sustained after discontinuing cleanser B, which con-
tained triclosan, salicylic acid, and azelaic acid.
Therefore, if it is combined with conventional ther-
apies, improvement can be achieved more effectively
and more easily. Observed clinical improvements are
supported by our histopathologic findings. Further
studies would be necessary for the elucidation of more
precise mechanisms.
Acknowledgements
This study was supported by Seoul National Univer-
sity Hospital Grant (06-2007-142-0).
Declaration of interest: The authors report no
conflicts of interest. The authors alone are responsible
for the content and writing of the article.

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