Journal of Cosmetics, Dermatological Sciences and Applications, 2013, 3, 190-196
http://dx.doi.org/10.4236/jcdsa.2013.33029 Published Online September 2013 (http://www.scirp.org/journal/jcdsa)
Compared Evaluation of Botulinum Toxin A and a
Cosmetic Antiperspirant in the Treatment of Focal
Axillary Hyperhidrosis
Meike Streker, Stefanie Lübberding, Martina Kerscher
Cosmetic Science, Department of Chemistry, University of Hamburg, Hamburg, Germany.
Email: meike.streker@chemie.uni-hamburg.de
,
Received March 27th, 2013; revised April 30th, 2013; accepted May 8th, 2013
Copyright © 2013 Meike Streker et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Background: Primary focal hyperhidrosis can significantly reduce quality of life. Therefore a lot of treatment options in
a range of conservative, physical and surgical techniques are available. Objective: To assess the efficacy of an antiper-
spirant containing aluminum chloride compared to a Botulinumtoxin A treatment for patients with primary focal hyper-
hidrosis. Methods and material: In this randomized, single-center, half-side trail, a clinical score was done by patients
and physician to evaluate the severity of hyperhidrosis. Gravimetric tests were performed to gather the amount of sweat
per unit of time. Furthermore the efficacy was determined using a four point questionnaire. Skin irritation was assessed
by measuring pH value and transepidermal water loss. Results: A total of 22 patients were enrolled. Two weeks after
baseline the hyperhidrosis level was significantly reduced (BTX-A: 92.9%, AL: 66.7%). In addition both treatment
options induced a significant reduction of sweat production (BTX-A: 80.8%, AL: 68.8%). Please change in: Patients
evaluated good resp, very good efficacy for both treatment options at day 28. pH value and TEWL never left physio-
logical range. Conclusion: Both botulinum toxin A treatment and an antiperspirant containing aluminum chloride in the
evaluated galenic formulation are an effective and safe treatment option for axillary focal hyperhidrosis.
Keywords: Hyperhidrosis; Aluminum Chloride; Botulinum Toxin; Antiperspirant; Sweating
1. Background
Primary focal hyperhidrosis is a disorder of excessive
eccrine sweating that mainly affects the axillae, palmae
and plantae. At least 3% of the population is affected
persuadably with a high number of unreported cases due
to an associated social phobia [1,2]. According to a study
by Strutton et al., both axillary and palmar hyperhidrosis
have the earliest average age of onset between 13 and 19
years [3]. The mean peak differs between 18 and 54
years. A genetic disposition is assumed, due to a high
percentage of positive family history.
Hyperhidrosis can lead to frustration, embarrassment,
a low self-esteem and finally may rest in social with-
drawal [4]. Patients who are affected by axillary hyper-
hidrosis must change their clothing several times a day or
choose only dark clothing which sweat points are not as
visible. In addition skin maceration and secondary skin
diseases such as fungal infection are promoted and bac-
terial colonization particularly leads to an unpleasant
odor that also can significantly reduce quality of life [5].
The treatment options for primary focal hyperhidrosis
involve a range of conservative, physical and surgical
techniques. Iontophoresis causes a blockage of the sweat
duct in the stratum corneum by directing a mild electrical
current. However long-term maintenance therapy is re-
quired to keep patients without symptoms [6,7]. Anticho-
linergic agents have substantial side effects such as dry-
ness of mouth, constipation and blurring of vision [8,9].
Surgical therapeutic options like endoscopic sympathec-
tomy are effective but have a main limitation in a great
potential of side effect and in a high incidence of mild to
severe compensatory hyperhidrosis [10].
Due to the limitation of the mentioned therapeutic op-
tions, the treatment of primary focal hyperhidrosis with
aluminum chloride or botulinum toxin A is the most
popularly therapeutic option. Both efficacies are proven
in several studies and the basic mechanism of actions has
been established [11-16].
Aluminum chloride in concentrations of 12.5% to 25%
reduces sweating by occluding the ducts of the eccrine
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Compared Evaluation of Botulinum Toxin A and a Cosmetic Antiperspirant
in the Treatment of Focal Axillary Hyperhidrosis
191
sweat glands [11,13]. They diffuse into the sweat duct
and form complexes with mucopolysaccharides and
metal ions. Compared with the nocturnal activity of ec-
crine sweat glands antiperspirants including aluminum
chloride have to apply at night. In some cases the appli-
cation of aluminum chloride must be discontinued because
of skin irritations.
Intradermal injections of botulinum toxin A reversibly
block autonomic cholinergic nerve fibres. Acetylcholine
is no longer released and the sweat glands chemically
denervated [16]. Earlier studies have shown the efficacy
in reducing sweat production. In addition, since there is a
successful treatment of focal hyperhidrosis with botuli-
num toxin A in a few case reports, chemodenervation has
emerged as a safe and effective treatment in several
clinical trials [17-20]. Because of disappearing after 6
month, this treatment option is costly intensive.
The aim of the study was to compare a single treat-
ment of botulinum toxin A with topical treatments of an
antiperspirant, including aluminum chloride in a low dose
formation for patients with primary focal hyperhidrosis
using clinical scores and biophysical measurements.
2. Methods
2.1. Patients
This randomized, single-center half-side trail was con-
ducted between March and September 2011. It was ap-
proved by the local ethical committee of Hamburg, Ger-
many. Patients with primary focal hyperhidrosis on basis
of the history questionnaire according to Bechara and of
sweat production greater than 50 mg per minute were
included [21]. Moreover subjects who have not used an-
tiperspirant, iontophoresis in the last 6 month or had been
treated with botulinum toxin A in the last 12 month were
selected. Patients had to understand the requirements of
the study and sign an informed consent form. Skin dis-
eases such as atopic dermatitis or fungal infections in the
treatment area or known intolerability of aluminum salts
were represented exclusion criteria. In total we enrolled
22 female patients aged 32 to 60 years.
2.2. Study Design and Measurements
After enrollment, patients received therapy with 12.5%
aluminum chloride (Sweat-Off®, Sweat-off GmbH, Hü-
gelsheim, Germany) on one side and 50 U of onabotu-
linumtoxin A. on the contralateral side following a ran-
domization plan.
For the first two weeks the patients were asked to use
the topical antiperspirant every evening. After reduce of
the sweat production the patients have to apply the pre-
paration according to the sweating.
For each patient one vial of onabotulinumtoxin A
(BTX-A) was prepared according to the randomization
plan. One vial contained 100 U powders for solution
which was reconstituted with 4.0 ml sterile physiological
(0.9%) sodium chloride solution. After cleaning the
treating area local anesthetic was applied before injection.
All patients received 50 U of onabotulinumtoxin A into
10 to 15 intradermal injection points in an even distribu-
tion within the hyperhidrotic area which were previously
defined by Minor’s iodine-starch test.
The severity of hyperhidrosis was determined using a
clinical score by Wörle et al. [21]. This was performed
by investigator and patients themselves.
Gravimetric measurements were performed to evaluate
the amount of sweat per unit of time. After an acclima-
tion time of 30 min the amount of sweat was absorbed by
filter paper (Melitta, Minden, Germany) and subsequent-
ly weighed using an ultra-fine scale.
In addition a four point subject questionnaire was per-
formed to evaluate the efficacy; following the points: no
efficacy, minimal efficacy, good efficacy and very good
efficacy.
To evaluate the tolerability of the treatments, the pH
value was measured using a combination electrode with
the measurement and reference electrodes integrated in a
single probe with measurement of potential using elec-
trodes made of silver chloride or mercuric wire (Skin pH
Meter PH 900, Courage and Khazaka, Cologne, Ger-
many). In addition the transepidermal water loss (TEWL)
was measured by using a condenser-chamber method
(Aqua Flux Model AF200, London, UK) to evaluate the
effects of aluminum chloride and botulinum toxin A of
the skin barrier.
All measurements were performed at baseline, at day
14, at day 28, at day 84 and at day 168 after first treat-
ment (Table 1). Statistical analyses were performed with
SPSS®. The data were analyzed using the Kolmogorov-
Smirnow test and the paired t-test. Values of p 0.05
were considered significant.
3. Results
Data from 22 patients (mean age MV 47.8 ± 5.7) where
was eligible. Baseline characteristics like age, weight and
bodymass-index were not associated with sweat produc-
tion.
Both injection with 50 U onabotulinumtoxin A and the
treatment with an antiperspirant containing aluminum
chloride induced a significant reduction of sweat secre-
tion (Figure 1). At visit 2, 14 days after treatment resp.
after starting treatment the hyperhidrosis level decreased
treatment 92.9%, after topical aluminum chloride
66.7%. At visit 3, 28 days the reduction in both thera-
peutic options was significant (BTX-A 100%; AL
Copyright © 2013 SciRes. JCDSA
Compared Evaluation of Botulinum Toxin A and a Cosmetic Antiperspirant
in the Treatment of Focal Axillary Hyperhidrosis
Copyright © 2013 SciRes. JCDSA
192
Table 1. Study overview.
Baseline V1 0 1 - 13 V2 14 15 - 27V3 28 29 - 84V4 84 85 - 167V5 168
enrollment X - - - - - - - - -
injection - X - - - - - - - -
acclimazation of 30 min X X - X - X - X - X
apply of antiperspirant - X X - X - X - X -
gravimetric measurements X X - X - X - X - X
clinical score - X - X - X - X - X
pH-value - X - X - X - X - X
TEWL - X - X - X - X - X
Figure 1. Degree of hyperhidrosis compared to baseline (p < 0.05).
73.3%; p 0.05). 6 months after injection the BTX-A
treated side was till significant reduced. Furthermore the
aluminum chloride treated side was also still decreased.
The mean rates of sweat production at baseline were
165 mg/5 min in the axillae assigned to the treatment
with botulinum toxin A and 184 mg/5 min in the axillae
assigned to the treatment with aluminum chloride. The
sweat production of both sides decreased significantly
over the whole study period (Figure 2). Two weeks after
initial treatment, the mean rates of sweat production were
31 mg/5 min in the axillae treated with botulinum toxin
A and 57 mg/5 min in the axillae treated with aluminum
chloride (BTX-A 80.8%; AL 68.8%; p < 0.05). 168
days after baseline the sweat production were 65 mg/5
min in the axillae treated with BTX-A and 57 mg/5 min
in the aluminum chloride treated side (BTX-A 60.4%;
AL 68.9%; p < 0.05).
Patients evaluated for both products 28 days after
baseline good efficacy resp. very good efficacy. 6 mon-
ths after baseline patients rated the BTX-A treated side
between minimal to good efficacy and the antiperspirant
treated side as minimal efficacy (Figure 3).
The evaluation of skin surface pH revealed a reduction
for both test products at all follow-up visits. During the
use of the antiperspirant the pH-value decreased for 13%.
After injection of BTX-A the pH-value decreased for 7%,
6 months after baseline (Figure 4). Both reductions were
not statistically significant.
Compared Evaluation of Botulinum Toxin A and a Cosmetic Antiperspirant
in the Treatment of Focal Axillary Hyperhidrosis
193
Figure 2. Gravimetric values compared to baseline (p < 0.05).
Figure 3. Improvement of hyperhidrosis; 0 = no efficacy; 1 = minimal efficacy; 2 = good efficacy; 3 = very good efficacy.
The TEWL values increased in the axillae assigned to
the treatment with BTX-A over the study period. The
mean increase in the TEWL value two weeks after base-
line with BTX-A was 46.7%, after starting treatment
with aluminum chloride it was 12.8%. 84 days after base-
line the increase in the BTX-A treated side was 32.7%.
The axillae assigned to the aluminum chloride treated
side increased by 12.3%. At the last follow-up visit, 168
days after baseline the values after treatment with BTX-
A were decreased by 28.9%. The TEWL values after
treatment with aluminum chloride increased by 53.1%
(Figure 5).
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Compared Evaluation of Botulinum Toxin A and a Cosmetic Antiperspirant
in the Treatment of Focal Axillary Hyperhidrosis
194
Figure 4. pH value compared to baseline.
Figure 5. Transepidermal water loss compared to baseline.
During the whole study period there were no major
adverse events. 6 patients recorded a mild to moderate
irritation in skin after die first to third applications of the
antiperspirant. There were no adverse events associated
with the treatment with botulinum toxin A.
4. Discussion
Hyperhidrosis is a common pathological condition which
can have a profound effect on patient’s behavior. Ex-
cessive sweating can inhibit social life and therefore de-
crease patient’s quality of life. Further, an excessive
sweating can induce skin maceration and causes second-
dary microbial infections. Treating primary focal hyper-
hidrosis with aluminum chloride often is the first treat-
ment therapy option in dermatology. Major limitations of
aluminum chloride are stinging sensations and burning
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Compared Evaluation of Botulinum Toxin A and a Cosmetic Antiperspirant
in the Treatment of Focal Axillary Hyperhidrosis
195
after application. Moreover skin irritation can be a cumu-
lative side effect of long-term treatment.
Another effective treatment modality is the intrader-
mal injection of botulinum toxin A which has been stud-
ied in numerous clinical trials [15,17-20]. It has demon-
strated a sustained relief of symptoms with a good safety
profile in open-label studies of the treatment of axillary
hyperhidrosis. Naumann et al. demonstrated in a double-
blind, placebo-controlled trial a 93.8% response rate after
a single treatment with 50 U total onabotulinumtoxin A
and a safety profile that was comparable to that of pla-
cebo injections [19]. In addition Heckmann et al. showed
an efficacy of onabotulinumtoxin A in a placebo-con-
trolled trial [15].
Therefore we designed an inter-individual comparison
of onabotulinumtoxin A and a cosmetic antiperspirant
containing aluminum chloride in a panel of 22 female
patients suffering from hyperhidrosis as objected by gra-
vimetry.
Regarding skin physiology both treatments were well
tolerated. While TEWL decreased during both treatment
modalities (BTX-A: 5.9 to 5.54; AL: 5.97 to 5.17), skin
pH never left the physiological range.
Our study confirms and extends the results of previous
studies regarding the gravimetry, the rate of sweat pro-
duction and the tolerability [15-17,20-24].
Further to a previous study which compared botulinum
toxin A with a topical 20% aluminum chloride for the
treatment of focal axillary hyperhidrosis our data confirm
that both products provide efficacy treatment option al-
though our data are different concerning the tolerability
of the antiperspirant [25]. According to Flanagan et al.
the aluminum chloride treatment was well tolerated and
effective only in the minority of the patients. This might
be due to the lower dose of 12, 5% aluminum chloride.
However, while Flanagan et al. demonstrated a clean
superiority of onabotulinumtoxin A and a high risk for
skin irritation after treatment with aluminum chloride,
our data did not reveal any significant differences in ef-
ficacy and tolerability between both treatments. This
might be due to the special developed of non-alcoholic
galinic formation and the low aluminum chloride con-
centration of the Sweat-Off® lotion.
5. Conclusion
Treatments of axillary focal hyperhidrosis with BTX-A
or an antiperspirant containing aluminum chloride in the
evaluated galenic formulation and low dose concentra-
tion are effective and safe options. Both treatment mo-
dalities significantly reduced the degree of hyperhidrosis.
Patients rated both options as an effective treatment.
However, patients with sensitive skin treatments with on-
abotulinumtoxin A seem to have a better therapeutic in-
dex while topical treatment with aluminum chloride de-
monstrates a better economic impact.
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