BJD

C L I NI C A L T R IA L S British Journal of Dermatology

Oxybutynin as a treatment for generalized hyperhidrosis: a

randomized, placebo-controlled trial
M. Schollhammer,1,2 E. Brenaut,2 N. Menard-Andivot,3 M. Pillette-Delarue,1,2 A. Zagnoli,4 M. Chassain-Le Lay,1
B. Sassolas,5 N. Jouan,1,2 Y. Le Ru,1 C. Abasq-Thomas,2 M. Greco,1,2 K. Penven,1 A.M. Roguedas-Contios,2

-Goetghebeur,4 C. Gouedard,4 L. Misery2 and G. Le Gal6
D. Dupre
1
Dermatologist, Brest, France
2
Department of Dermatology and 5Department of Internal Medicine, University Hospital, Brest, France
3
Dermatologist, Quimper, France
4
Dermatologist, Landerneau, France
6
INSERM CIC 1412, Universite de Brest, Brest, France

Summary

Correspondence Background Hyperhidrosis is a disorder that can impair quality of life. Localized
Gregoire Le Gal. treatments may be cumbersome and ineffective, and no systemic treatments have
E-mail: gregoire.legal@chu-brest.fr proven to be significantly beneficial.
Objectives To evaluate the effectiveness and tolerance of low-dose oxybutynin for
Accepted for publication
11 June 2015
hyperhidrosis.
Methods We conducted a prospective, randomized, placebo-controlled trial. From
Funding sources June 2013 to January 2014, 62 patients with localized or generalized hyperhidro-
This study was partially funded by the French sis were enrolled. Oxybutynin was started at a dose of 2
5 mg per day and
Society of Dermatology (Call for Research Projects increased gradually to 7
5 mg per day. The primary outcome was defined as
in Private Practice).
improvement of at least one point on the Hyperhidrosis Disease Severity Scale
Conflicts of interest (HDSS). Dermatology Life Quality Index (DLQI) and tolerance were also reported.
L.M. has been an investigator and speaker for Results Most patients (83%) in our study had generalized hyperhidrosis. Oxybu-
Pfizer. tynin was superior to placebo in improving the HDSS: 60% of patients treated
with oxybutynin, compared with 27% of patients treated with placebo, improved
M.S. and E.B. contributed equally to this work. at least one point on the HDSS (P = 0
009). The mean improvement in quality
of life measured by DLQI was significantly better in the oxybutynin arm (6
9)
DOI 10.1111/bjd.13973
than in the placebo arm (2
3). The most frequent side-effect was dry mouth,
which was observed in 43% of the patients in the oxybutynin arm, compared
with 11% in the placebo arm.
Conclusions Treatment with low-dose oxybutynin is effective in reducing symp-
toms of hyperhidrosis in generalized or localized forms. Side-effects were fre-
quent but minor and mainly involved dry mouth.

What’s already known about this topic?

• Hyperhidrosis is a frequent disorder that can impair quality of life. Treatments are
not always effective.

What does this study add?

• In this randomized, placebo-controlled trial, oxybutynin was effective in 60% of
patients with hyperhidrosis, and this treatment is inexpensive and well tolerated.
• Oxybutynin should be considered as a therapeutic option for patients with hyper-
hidrosis.
• This is the first study to include generalized hyperhidrosis, and not only localized
forms.

© 2015 British Association of Dermatologists British Journal of Dermatology (2015) 173, pp1163–1168 1163
1164 Oxybutynin for generalized hyperhidrosis, M. Schollhammer et al.
Hyperhidrosis is frequently observed in dermatological prac-
tice. The prevalence of hyperhidrosis is estimated to be
between 1% and 2
9% in the general population.1,2 The
most frequent form is primary hyperhidrosis, which is local-
ized to the palms, soles, axillae, trunk and face, and is exac-
erbated by intense emotion or stress. Secondary
hyperhidrosis can be localized or generalized and is associ-
ated with other systemic disorders such as malignancy and
infectious, endocrine or neurological disorders. Quality-of-
life impairment (i.e. occupational, emotional, psychological,
social and physical) can be severe. This negative impact on
health-related quality of life has been reported by validated
questionnaires to be similar to or greater than that reported
for other dermatological (e.g. psoriasis) and nondermatologi-
cal chronic diseases.3 Despite an impaired quality of life,
patients do not show increased symptoms of anxiety,
depression or social phobia.3 Some treatments are available
for localized hyperhidrosis. These include topical aluminium
chloride hexahydrate, tap water iontophoresis or intradermal
injection of botulinum toxin, but they are not always effi-
cient. No treatment has been validated for generalized
hyperhidrosis.
Oxybutynin is a cholinergic antagonist that is used to treat
pollakiuria and hyper-reflectory urine bladder, and it is gen-
erally used at a dose of 10–15 mg per day. In 1988 a case
report described a patient with hyperhidrosis who began tak-
ing oxybutynin for urinary urgency; his episodes of severe
sweating were abolished within a few hours.4 Subsequently,
four other cases have been reported.5–7 Several series of
patients treated with oxybutynin have been published,8–10
including from specific populations such as postmenopausal
patients,10 children11 and obese patients,12 and from specific
locations, such as plantar,13 palmar14 or facial15 hyperhidro-
sis. Two randomized trials evaluated its use in patients with
localized palmar or axillar hyperhidrosis,16 and in women
with persistent plantar hyperhidrosis despite sympathec-
tomy.17
To date, no study has evaluated the efficacy and tolerance
of oxybutynin in generalized hyperhidrosis. To fill this knowl-
edge gap, we designed a placebo-controlled trial of low-dose
oxybutynin in patients with primary generalized or localized
hyperhidrosis.
Materials and methods
This was a multicentre (Brest, Quimper, Landerneau, Mor-
laix), prospective, randomized, placebo-controlled clinical
trial. The trial was registered on ClinicalTrials.gov, with the
title ‘Treatment of hyperhidrosis with oxybutynin’ and the
identifier NCT01855256.
The study protocol was approved by the institutional ethics
committee (Comit
e de Protection des Personnes Ouest VI,
Brest, France) and the French national health authority, the
ANSM (Agence Nationale de S
ecurit
e du M
edicament et des
Produits de Sant
e).
British Journal of Dermatology (2015) 173, pp1163–1168
Participants
From June 2013 to January 2014, 62 consecutive patients
with primary hyperhidrosis, generalized or localized (palmar,
plantar, axillary, facial or truncal), and whose Hyperhidrosis
Disease Severity Scale (HDSS)18 was ≥ 2 were asked to partici-
pate in the study. On the HDSS, the patients answered the
question, ‘How would you rate the severity of your sweat-
ing?’, and the answer was classified on a four-point scale: 1,
my sweating is never noticeable and never interferes with my
daily activities; 2, my sweating is tolerable but sometimes
interferes with my daily activities; 3, my sweating is barely
tolerable and frequently interferes with my daily activities; or
4, my sweating is intolerable and always interferes with my
daily activities.
The patients came from 11 private dermatology physicians’
offices and one hospital outpatient dermatology unit. Other
eligibility criteria included age ≥ 18 years, affiliation with the
National Health Insurance system, and the ability and consent
to enrol. Exclusion criteria were age < 18 years, patient not
reachable for follow-up, patient currently participating in
another clinical trial, current pregnancy, breastfeeding, hyper-
sensitivity to oxybutynin or any of the excipients, known pro-
static disorders, intestinal occlusion, toxic megacolon,
intestinal atony, severe ulcerative colitis, myasthenia and clo-
sure glaucoma of the anterior chamber angle. Written consent
was obtained from all patients.
Interventions
The patients were randomized using a computer-generated list
of random numbers, through a dedicated website. Randomiza-
tion lists were stratified by centre (Brest, Quimper, Lan-
derneau, Morlaix), and the randomization sequence was kept
concealed from both patients and investigators. Oxybutynin or
placebo was started at 2
5 mg per day and increased gradually
until it reached an effective dose, without exceeding 7
5 mg
per day. The dose of oxybutynin or placebo was 2
5 mg per
day from day 1 to 4, at which point patients could increase to
5 mg per day from day 5 to 7 and to 7
5 mg per day from
day 8 to the end of the 6 weeks. The placebo was produced
by the hospital pharmacy and had exactly the same appearance
as oxybutynin.
Outcomes
The primary outcome was improvement of one point or more
on the HDSS.18 The HDSS was evaluated at the beginning of
the study and after 6 weeks of treatment.
The secondary outcome was improvement of quality of
life evaluated with the Dermatology Life Quality Index
(DLQI).19 The DLQI score was evaluated at the beginning of
the study and after 6 weeks of treatment. Tolerance was also
evaluated by the reporting of side-effects at the follow-up
visit.
© 2015 British Association of Dermatologists
 Oxybutynin for generalized hyperhidrosis, M. Schollhammer et al. 1165
Sample size
Power analysis (a = 0
05; b = 0
80) determined that a sam-
ple size of 28 patients in each group was needed to detect a
decrease of one point or more on the HDSS, with an expected
response of 70% in the oxybutynin group and 30% in the pla-
cebo group. Thirty patients were enrolled per group to allow
for dropouts. To recruit this sample of patients, a 12-month
inclusion period was anticipated.
Statistical methods
The percentage of patients with improvement of at least one
HDSS point was estimated in each arm and compared using a
v2-test. In secondary analysis, Student’s t-test was used to
compare the mean improvement of the DLQI score between
the two groups. The significance level considered for all statis-
tical tests was 0
05. The study was analysed using intention-
to-treat analysis, including all patients who received at least
one dose of the study drug.
Results
The flow of patients is summarized in Figure 1. Sixty-two
patients satisfied the eligibility criteria and were included in
the study; 32 were randomized to oxybutynin and 30 were
randomized to placebo. Two patients withdrew their consent
Assessed for eligibility (n = 62)
Randomized (n = 62)
Allocated to arm oxybutynin (n = 32)
- Received allocated intervenon (n = 30)
- Did not receive allocated intervenon (n = 2) (Two paents
decided to stop study before receiving allocated
intervenon)
Lost to follow-up (n = 0)
Disconnued intervenon (n = 0)
Analysed (n = 30)
Fig 1. Flow diagram of this double-blind, prospective, randomized, placebo-controlled trial of oxybutynin or placebo in patients with
hyperhidrosis.
© 2015 British Association of Dermatologists
before receiving the first dose of the allocated intervention
and were not included in the analysis (oxybutynin arm,
n = 2). One patient was lost to follow-up (placebo arm,
n = 1) and another decided to withdraw from the study on
day 2 (placebo arm, n = 1). The intention-to-treat analysis
involved 30 patients in the oxybutynin arm and 30 patients in
the placebo arm. The demographic and baseline clinical char-
acteristics of the patients are summarized in Table 1. Most
patients (83%) had generalized hyperhidrosis, which was
defined by two or more locations (among palmar, plantar,
axillary, facial or truncal), and 17% had localized hyperhidro-
sis (defined by one location). All patients reached the dose of
7
5 mg per day, except for one who remained at 5 mg per
day.
At 6 weeks, the patients were classified according to
whether they had improvement of one point or more on the
HDSS (Table 2). In the intention-to-treat analysis, more
patients had improvement of HDSS in the oxybutynin arm
(60% of patients) than in the placebo arm (27%) and this dif-
ference was statistically significant (P < 0
01). The mean
improvement of DLQI was significantly better in the oxybu-
tynin arm (6
9) than in the placebo arm (2
3) (P < 0
01).
The side-effects observed in the two groups are presented in
Table 3. Dry mouth was significantly (P < 0
01) more fre-
quent in the oxybutynin arm (13 of 30 patients, 43%) than
in the placebo arm (three of 28 patients, 11%). Among the
13 patients with dry mouth in the oxybutynin arm, six (46%)
Allocated to arm placebo (n = 30)
- Received allocated intervenon (n = 30)
- Did not receive allocated intervenon (n = 0)
Lost to follow-up (n = 1)
Disconnued intervenon (n = 1) (paent䇻s decision to
withdraw)
Analysed (n = 28)
British Journal of Dermatology (2015) 173, pp1163–1168
1166 Oxybutynin for generalized hyperhidrosis, M. Schollhammer et al.

Table 1 Demographic and baseline clinical characteristics of patients Table 3 Distribution of side-effects
with hyperhidrosis who were randomized to receive oxybutynin or
placebo Oxybutynin Placebo
(n = 30), n (%) (n = 28), n (%)
Oxybutynin (n = 30) Placebo (n = 30) Gastrointestinal effects
Age (years) Dry moutha 13 (43) 3 (11)
Median (range) 33
5 (18–62) 35
0 (18–58) Nausea 1 (3) 0 (0)
Mean  SD 34
3  11
3 36
4  12
3 Diarrhoea 1 (3) 1 (4)
Sex, n (%) Gastro-oesophageal reflux 1 (3) 0
Female 19 (63) 15 (50) Abdominal pain 0 1 (4)
Male 11 (37) 15 (50) Central nervous system effects
HDSS, n (%) Headache 1 (3) 0
4 10 (33) 10 (33) Asthenia 1 (3) 0
3 17 (57) 18 (60) Dizziness 1 (3) 1 (4)
2 3 (10) 2 (7) Flush 1 (3) 0
DLQI score Blurred vision 4 (13) 0
Median (range) 11
0 (5–22) 11
5 (2–18) Urinary difficulty 1 (3) 0
Mean  SD 11
4  4
1 10
8  4
7 a
P = 0
0034 (v2-test).
n = 32 Allocated
Hyperhidrosis location, n (%)
Palmar 22 (69) 14 (47) receiving oxybutynin than in those receiving placebo: 60% vs.
Plantar 22 (69) 17 (57) 27%, respectively. Among the 18 patients who improved on
Axillary 24 (75) 21 (70) oxybutynin, there was a three-point improvement on the
Facial 7 (22) 12 (40) HDSS in 11% of the patients, a two-point improvement in
Truncal 13 (41) 13 (43)
61% and a one-point improvement in 28%. Among the eight
Type of hyperhidrosis, n (%)
Localized 5 (17) 5 (17)
patients who improved on placebo, improvement on the HDSS
Generalized 25 (83) 25 (83) was only one point in most cases (75%) and two points in
25% of cases. Among the patients without improvement, the
HDSS, Hyperhidrosis Disease Severity Scale; DLQI, Dermatology
Life Quality Index.
score was stable but never worse. Thus, improvement was
more frequent and significant in patients treated with oxybu-
tynin than in patients on placebo, and this could be regarded
as clinically significant. In parallel to improvement on the
Table 2 Classification of patients after treatment: improvement of one
HDSS, there was an improvement in quality of life.
point or more of the Hyperhidrosis Disease Severity Scale (HDSS) or The doses of oxybutynin used to treat urinary disorders are
no improvement of HDSS greater (15 mg per day) than those we used to treat hyper-
hidrosis. Previous studies on hyperhidrosis used doses up to a
Oxybutynin, n (%) Placebo, n (%) maximum of 7
5 mg per day8 or more often 10 mg per
Improvement of HDSS 18 (60) 8 (27)
day.10,16,17,20 We decided to use a maximum dose of 7
5 mg
Level of improvement per day to avoid side-effects, which are dose dependent. The
1 point 5 (28) 6 (75) treatment was well tolerated and no patient stopped the study
2 points 11 (61) 2 (25) drug because of side-effects. No serious adverse events were
3 points 2 (11) 0 reported. In our study, dry mouth was frequent (43% in the
No improvement of HDSS 12 (40) 20 (67) oxybutynin group vs. 11% in the placebo group) but usually
Same score 12 20
of slight (46%) or mild intensity (38%). When used for uri-
Worse score 0 0
Lost to follow-up 0 2 (7)
nary incontinence, oxybutynin caused dry mouth in approxi-
mately 70–80% of patients.21
There is no validated objective method to measure the
intensity of hyperhidrosis.22 Measures depend on the location
evaluated this symptom as having slight intensity, five (38%) and can be different for palmar, plantar or axillar disease, for
as having mild intensity and two (15%) as having severe example. In most cases, the decision to treat a patient is based
intensity. only on their description of the symptoms. Subjective tools
seem better than objective methods because impairment of
quality of life depends not only on the severity of hyperhidro-
Discussion
sis but also on each patient’s individual adaptation. For this
In this study, oxybutynin at a low dose was superior to pla- subjective evaluation, we decided to use a validated scale, the
cebo in relieving symptoms of localized and generalized HDSS,18,23 as our primary outcome. It is a single-item four-
hyperhidrosis. The HDSS improved more in the patients point scale on which patients rate the tolerability of their

British Journal of Dermatology (2015) 173, pp1163–1168 © 2015 British Association of Dermatologists
 Oxybutynin for generalized hyperhidrosis, M. Schollhammer et al. 1167
hyperhidrosis symptoms and the degree of interference with
the activities associated with those symptoms. The HDSS had
the advantage of being previously validated.18 However, due
to it being a four-point scale, it is less sensitive, which may
account somewhat for the lower rates of efficacy than previ-
ously reported.
The DLQI was used to assess the patients’ quality of life.19
It is a validated 10-item questionnaire with questions on lei-
sure, personal relationships, daily activities and treatment. The
maximum score is 30, with 0 indicating the least impairment
and 30 the most impairment in a patient’s quality of life.
Topical treatments for hyperhidrosis include topical alu-
minium chloride hexahydrate, tap water iontophoresis and
intradermal injection of botulinum toxin.23–25 Surgical tech-
niques for treatment of hyperhidrosis include endoscopic
transthoracic sympathectomy, excision of axillary sweat glands
and axillary liposuction. Other medications have been used in
hyperhidrosis. Oral glycopyrrolate was effective, but treatment
was limited by side-effects in approximately one-third of
patients.26 In another retrospective study27 with 31 children
treated with oral glycopyrrolate, 90% of patients experienced
improvement, but side-effects were noted by 29% of children,
most commonly dry mouth (26%) and eyes (10%). Clonidine
had a response rate of 46% with frequent adverse effects such
as decreased blood pressure.28 Use of benzodiazepines can also
be helpful through their anxiolytic mechanism of action. Nev-
ertheless, benzodiazepines are not used very often due to their
induced side-effects such as drowsiness and cognitive impair-
ment, as well as the risk of dependency and withdrawal.25
A few papers have been published during the past few years
showing interest in oxybutynin, but mainly in case reports4–7
or open trials.8–10,14,15,20 One randomized, placebo-controlled
trial with oxybutynin16 for treatment of palmar or axillary
hyperhidrosis has been published, with similar results to ours.
Recently, another randomized trial was published on persistent
plantar hyperhidrosis in women after sympathectomy.18 Six-
teen patients were included in each group (placebo and oxy-
butynin); there was a clinical improvement based on the
quality-of-life questionnaire and a significant decrease in
transepidermal water loss in the oxybutynin group. These
studies demonstrated the efficacy and raised interest for oxy-
butynin treatment in localized hyperhidrosis. Oxybutynin
might also be useful in healthy individuals who may experi-
ence an aggravation of dermatoses as a result of sweating.
However, in a randomized, double-blind, placebo-controlled
trial, oxybutynin did not result in inhibition of exercise-
induced sweating in normohidrotic individuals.29
One limitation of our study is its relatively short duration,
with a follow-up period of 6 weeks. Admittedly, we cannot
provide any information on the long-term efficacy and safety
of oxybutynin beyond this period. In studies with a longer
follow-up (3 months),10,13 it is noticeable that patients con-
tinue using the medication despite side-effects, suggesting that
these effects are not so important compared with improve-
ment of hyperhidrosis. Another limitation is the relatively
small sample size, which might have prevented us from
© 2015 British Association of Dermatologists
detecting rare adverse events. It could have been interesting to
include only generalized forms of hyperhidrosis. The last limi-
tation is the unblinding that will inevitably occur in the
patients in the oxybutynin group, due to side-effects.
In conclusion, in this randomized controlled study of oxy-
butynin for generalized or localized hyperhidrosis, oxybutynin
was effective at relieving symptoms and improving quality of
life. Side-effects were minor, with dry mouth the most fre-
quent. This treatment can be used for patients with mild or
severe hyperhidrosis with an impaired quality of life. This is
the first randomized trial with oxybutynin including patients
with generalized hyperhidrosis and not only localized forms.
Acknowledgments
We acknowledge for their contributions Emmanuel Nowak,
Florence Morvan, Ga€elle Larhantec, Julien Coadic, Maelenn
Gouillou, Zarrin Alavi, Delphine Legoupil, Patrice Plantin,
Karine Sannier and Patricia Schoenlaub.
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© 2015 British Association of Dermatologists