ARTICLE
Auteur(s) : Anna
Campanati1, Maria Luisa Bernardini1,
Rosaria Gesuita2, Annamaria Offidani1
1Dermatological Clinic, Clinica Dermatologica,
Ospedale Torrette, Via Conca 71 Ancona, 60020, Italy
2Department of Epidemiology, Biostatisctics and Medical
Information Technology, Polytechnic Marche University, Ancona
accepté le 28 Août 2006
Hyperhidrosis is a disorder characterized by excessive sweating
that involves the eccrine sweat glands. There are considerable
emotional and social stigmata attached to this condition [1,
2].Patients afflicted with this type of disorder, especially those
suffering from the plantar form, can routinely soak through
clothing in a matter of minutes and resort to pads, shields,
absorbent tissue, and frequent changes of clothing to cope with the
disorder [1, 2].Even if several studies have shown that botulinum
toxin type A (BTX-A) represents a safe and effective treatment for
axillary and palmar hyperhidrosis, very few data are reported in
literature regarding its use in the plantar form [9, 11].The aim of
this pilot study was to evaluate the effect of BTX-A on plantar
hyperhidrosis over a period of sixteen weeks after treatment.
Materials and methods
A total of 10 patients (5 women and 5 men) suffering from
idiopathic plantar hyperhidrosis resistant to any prior topical
treatment were included in the study and treated with BTX-A
injections. Ethics committee approval was obtained and all patients
gave their informed consent. Pregnant or nursing women, as well as
patients with secondary hyperhidrosis or neuromuscular changes, and
those using systemic medications that could interfere with
neuromuscular activity were excluded from this study.
All patients underwent a complete evaluation consisting of
clinical assessment, photodocumentation of sweat production and
subjective evaluation of disability caused by the symptoms of
hyperhidrosis. The clinical assessment included a pre-treatment
semi-objective examination of sweat production. Pre-treatment
haematological analyses were also carried out to exclude the
presence of any systemic disease underlying hyperhidrosis.
Visualization of the hyperhidrotic area was obtained using the
Minor-iodine-starch test. In this test an iodine solution (2 g of
iodine in 10 mL of almond oil and alcohol) is painted on the
area of skin to be tested. Once it dries out, fine rice starch
powder is applied on it. Sweat production then causes the mixture
to turn dark blue, thus making it easy to discern the exact
location and extension of sweating in the target zone (sweating
grade ranges from 0 to 3).
Subjective evaluation of disability caused by the symptoms of
hyperhidrosis was obtained using the Dermatology Life Quality Index
(DLQI) [12].
The DLQI is a quality of life measure that can be used across
all skin diseases and is also a validated tool to measure the
degree of change in longitudinal studies [13], for example to
measure the effect of a treatment on the quality of life of
patients. It consists of 10 questions regarding work, leisure,
daily activities, personal relationships and treatments. Each
question has five alternative answers: “very much”, “a lot”, “a
little”, “not at all” or “not relevant” with corresponding scores
of 3, 2, 1, 0 respectively (the answer “not relevant” is scored as
0, as suggested by Finlay et al. [12]). The results can
be easily computed by summing the score of each question, resulting
in a global value ranging from 0 to 30. The higher is the score,
the greater is the impairment in the quality of life.
During the follow-up period (1, 4, 8, 12 and 16 weeks after
treatment) each patient underwent Minor’s test and received the
DLQI questionnaire from a clinician external to the study.
Treatment with botulinum toxin type A
In all patients the hyperhidrotic area was evaluated by the Minor
iodine starch test and then subdivided into squares
1.5 × 1.5 cm (2.25 cm2). Lyophilised botulinum
toxin type A (BOTOX®, Allergan, Irvine, California, USA)
100 mouse units (MU), was diluted in 5 mL sterile 0.9% saline
solution. A total amount of 100 MU was injected intracutaneously
and distributed into each 2.25 cm2 area using a
single injection with a 30G × 0.30 × 4 mm gauge needle.
Topical anaesthetics such as EMLA (Astra Pharmaceuticals,
Westborough, MA) were applied 60 minutes before injection to reduce
the discomfort.
Statistical analysis
A non parametrical analysis of variance for repeated measurement
was used to evaluate DLQI index and Minor’s test values across the
points-time. Comparisons between baseline and T1-T16 measurements
were performed to evaluate the significant differences across the
time. A level of probability equal to 5% was used to assess the
statistical significance. Results were expressed as median,
25th and 75th percentiles.
Results
Quality of life showed a significant improvement lasting for 12
weeks after treatment: the DLQI index values from T1 to T12
resulted significantly lower than the basal value (table 1)( Table 1 )); no significance difference was
found between T16 and basal values (table 1).
A significant reduction with respect to the basal value in sweat
production resulted from T1 to T8 (table 1); the Minor’s score at
T12 and T16 was not significantly different from the basal value
(table 1).
Table 1 DLQI index and Minor’s test in patients treated
with BTX-A for plantar hyperhidrosis
|
DLQI index
|
Basal
|
T1
|
T4
|
T8
|
T12
|
T16
|
|
Median
|
19
|
5
|
4
|
7
|
8.5
|
15
|
|
25th-75th percentiles
|
18-20
|
2-8
|
2-8
|
5-9
|
7-10
|
14-18
|
|
Comparisons towards the basal
|
|
p < 0.01
|
p < 0.01
|
p < 0.01
|
p < 0.05
|
ns
|
|
MINOR’s Test
|
|
|
|
|
|
|
|
Median
|
3
|
1
|
1
|
1
|
2
|
3
|
|
25th-75th percentiles
|
3-3
|
1-2
|
1-2
|
1-2
|
2-2
|
2-3
|
|
Comparisons towards the basal
|
|
p < 0.01
|
p < 0.01
|
p < 0.01
|
ns
|
ns
|
Discussion
Plantar localization represents a functional problem for patients
suffering from hyperhidrosis, since topical treatments
(astringents, local antiperspirants, iontophoresis) are usually
ineffective and the surgical approach is not recommended [1].
Several data have been published regarding the use of BTX-A in
the treatment of palmar [1, 2, 5-7] and axillary hyperhidrosis
[1-4, 6, 7], the duration of the anhydrotic effects ranging form
12-20 weeks for palmar sites to 24-32 weeks in axillary sites [8],
whereas few data are reported regarding the effectiveness, safety
and duration of the effect in plantar zones [9-11].
In the present study, all the patients experienced a clinical
improvement after the treatment, with sweat production level
significantly lower than baseline until the 12th week
after the treatment.
A recent study has demonstrated that a DLQI score of > 10
means that a skin disease is having a very severe effect on the
patient’s QoL [14]; in our case-series the median value at baseline
was 19, but after treatment also the quality of life showed a great
and significant improvement both in the period immediately after it
and for the subsequent 12 weeks.
However at T16 all the treated patients experienced symptoms
relapse with a significant worsening of life quality.
Vadoud-Seyedi J et al. [9] reported 10 cases of plantar
hyperhidrosis treated with injections of 50 MU BTX-A, with 7
patients symptom free for up to 20 weeks. Unfortunately, both the
administration of BTX-A and the evaluation of life quality were
performed in a different manner, therefore the results of our
series cannot be compared to the results of their series.
Nevertheless, data of our pilot study confirm that BTX-A
significantly reduces sweat production in plantar hyperhidrosis
over a period of 12 weeks after a single treatment session in
almost all patients. Moreover the treatment seems to be safe as far
as no relevant side effects were detected, especially no transient
weakness in neighbouring muscles of treated patients.
The duration of the anhydrotic effects in the plantar zone does
not seem to last as long as in any other treated area (e.s. axillae
and palms), but the real reason for this difference is not
clear.
This is why wide clinical trials are needed, especially to
understand the cause of this variation in therapeutic effects and
to establish the most appropriate dose for the treatment of this
zone.
Acknowledgements
We wish to thank Dr. C. Previtali for writing assistance. Financial
support: None. Conflict of interest: None.
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