10.5826/dpc.1303a192
Introduction: Hyperhidrosis is excessive sweating beyond thermoregulatory needs. It is a potentially disabling condition with challenging management. Aluminum chloride is the established topical treatment; however, response remains unsatisfactory. Oxybutynin is an anticholinergic drug that stands as a therapeutic chance for hyperhidrosis.
Objectives: comparing the efficacy of topical oxybutynin 3% gel versus aluminum chloride 15% lotion in treatment of primary focal hyperhidrosis.
Methods: Forty patients with hyperhidrosis were randomly distributed into 2 equal groups treated by either topical oxybutynin 3% gel or topical aluminum chloride 15% lotion once daily night application for 4 weeks (both groups). Evaluation was done at 2 and 4 weeks of treatment and after 1 month of the end of treatment for follow up by Minor iodine starch test, hyperhidrosis disease severity scale (HDSS) and dermatology life quality index (DLQI).
Results: Both treatment modalities were effective with insignificant differences between patients of both groups regarding improvement in Minor iodine starch test and HDSS after 2 weeks of treatment (P = 0.561, 0.33 respectively). Oxybutynin 3% gel yielded significantly better improvement of Minor’s test, HDSS and patient’s quality of life at the end of 4 weeks of treatment with lower recurrence rate than aluminum chloride 15% lotion at 1 month follow up. Minimal adverse effects were noted in both studied groups.
Conclusions: Oxybutynin 3% gel could be considered as a promising treatment modality for hyperhidrosis with higher efficacy than aluminum chloride 15% lotion and lower recurrence rate.
text/xml
2160-9381
3067
en
Iman  Hamed El-Maadawy
https://creativecommons.org/licenses/by-nc/4.0
Dermatology Practical & Conceptual
Topical
Topical Oxybutynin 3% Gel versus Aluminum Chloride 15% Lotion in Treatment of Primary Focal Hyperhidrosis
Text.Serial.Journal
https://dpcj.org/index.php/dpc
Original Article
2023-07-31
2022-12-11
2023-07-31
2023-09-26
e2023192
Dermatol Pract Concept
Introduction: Hyperhidrosis is excessive sweating beyond thermoregulatory needs. It is a potentially disabling condition with challenging management. Aluminum chloride is the established topical treatment; however, response remains unsatisfactory. Oxybutynin is an anticholinergic drug that stands as a therapeutic chance for hyperhidrosis.
Objectives: comparing the efficacy of topical oxybutynin 3% gel versus aluminum chloride 15% lotion in treatment of primary focal hyperhidrosis.
Methods: Forty patients with hyperhidrosis were randomly distributed into 2 equal groups treated by either topical oxybutynin 3% gel or topical aluminum chloride 15% lotion once daily night application for 4 weeks (both groups). Evaluation was done at 2 and 4 weeks of treatment and after 1 month of the end of treatment for follow up by Minor iodine starch test, hyperhidrosis disease severity scale (HDSS) and dermatology life quality index (DLQI).
Results: Both treatment modalities were effective with insignificant differences between patients of both groups regarding improvement in Minor iodine starch test and HDSS after 2 weeks of treatment (P = 0.561, 0.33 respectively). Oxybutynin 3% gel yielded significantly better improvement of Minor’s test, HDSS and patient’s quality of life at the end of 4 weeks of treatment with lower recurrence rate than aluminum chloride 15% lotion at 1 month follow up. Minimal adverse effects were noted in both studied groups.
Conclusions: Oxybutynin 3% gel could be considered as a promising treatment modality for hyperhidrosis with higher efficacy than aluminum chloride 15% lotion and lower recurrence rate.
Iman  Hamed El-Maadawy
2023/07/31
10.5826/dpc.1303a192
e2023192
Faculty of Medicine, Dermatology and Venereology Department, Tanta University, Tanta, Egypt
2160-9381
Topical
en
e2023192
Grabell DA, Hebert AA. Current and Emerging Medical Therapies for Primary Hyperhidrosis. Dermatol Ther (Heidelb). 2017;7(1):25-36. doi: 10.1007/s13555-016-0148-z. PMID: 27787745. PMCID: PMC5336423.
Topical Oxybutynin 3% Gel versus Aluminum Chloride 15% Lotion in Treatment of Primary Focal Hyperhidrosis
https://dpcj.org/index.php/dpc/article/download/3067/2197
         Topical Oxybutynin 3% Gel Versus Aluminum
         Chloride 15% Lotion in Treatment of Primary
                     Focal Hyperhidrosis
    Amany El-Agamy El-Samadony1, Doaa Salah Hegab1, Gamal Mohamed El Maghraby2,
                             Iman Hamed El-Maadawy1


1 Faculty of Medicine, Dermatology and Venereology Department, Tanta University, Tanta, Egypt
2 Faculty of Pharmacy, Pharmaceutical Technology Department, Tanta University, Tanta, Egypt



Key words: aluminum chloride, hyperhidrosis, oxybutynin, therapy, topical
Citation: El-Agamy El-Samadony A, Hegab DS, El Maghraby GM, El-Maadawy IH. Topical Oxybutynin 3% Gel versus Aluminum
Chloride 15% Lotion in Treatment of Primary Focal Hyperhidrosis. Dermatol Pract Concept. 2023;13(3):e2023192.
DOI: https://doi.org/10.5826/dpc.1303a192
Accepted: February 11, 2023; Published: July 2023
Copyright: ©2023 El-Agamy El-Samadony et al. This is an open-access article distributed under the terms of the Creative Commons
Attribution-NonCommercial License (BY-NC-4.0), https://creativecommons.org/licenses/by-nc/4.0/, which permits unrestricted
noncommercial use, distribution, and reproduction in any medium, provided the original authors and source are credited.
Funding: None.
Competing Interests: None.
Authorship: All authors have contributed significantly to this publication.
Corresponding Author: Doaa Salah Hegab, MD, Professor of Dermatology and Venereology, Dermatology and Venereology
Department, Faculty of Medicine, Tanta University, El Geish Street, Tanta, 31111, Tanta, Egypt. Telephone number: 00201224500857
E-mail: doaasalahhegab@yahoo.com




  ABSTRACT             Introduction: Hyperhidrosis is excessive sweating beyond thermoregulatory needs. It is a potentially
                       disabling condition with challenging management. Aluminum chloride is the established topical treat-
                       ment; however, response remains unsatisfactory. Oxybutynin is an anticholinergic drug that stands as
                       a therapeutic chance for hyperhidrosis.
                       Objectives: comparing the efficacy of topical oxybutynin 3% gel versus aluminum chloride 15%
                       lotion in treatment of primary focal hyperhidrosis.
                       Methods: Forty patients with hyperhidrosis were randomly distributed into 2 equal groups treated by
                       either topical oxybutynin 3% gel or topical aluminum chloride 15% lotion once daily night applica-
                       tion for 4 weeks (both groups). Evaluation was done at 2 and 4 weeks of treatment and after 1 month
                       of the end of treatment for follow up by Minor iodine starch test, hyperhidrosis disease severity scale
                       (HDSS) and dermatology life quality index (DLQI).
                       Results: Both treatment modalities were effective with insignificant differences between patients of both
                       groups regarding improvement in Minor iodine starch test and HDSS after 2 weeks of treatment (P = 0.561,
                       0.33 respectively). Oxybutynin 3% gel yielded significantly better improvement of Minor’s test, HDSS and
                       patient’s quality of life at the end of 4 weeks of treatment with lower recurrence rate than aluminum chlo-
                       ride 15% lotion at 1 month follow up. Minimal adverse effects were noted in both studied groups.




Original Article | Dermatol Pract Concept. 2023;13(3):e2023192                                                                       1
                     Conclusions: Oxybutynin 3% gel could be considered as a promising treatment modality for hyperhi-
                     drosis with higher efficacy than aluminum chloride 15% lotion and lower recurrence rate.




Introduction                                                      Methods
Hyperhidrosis is a dermatologic disorder characterized by         This single-blinded, prospective, comparative study in-
sweating beyond what is necessary for thermoregulation in         cluded 40 hyperhidrosis patients who did not receive any
the person environment. Primary and secondary hyperhidro-         treatment for the condition during the preceding 6 months
sis are the chief categories of the condition [1]. Diagnosis      and were selected from the outpatient clinics of Dermatol-
of primary hyperhidrosis is associated with hyperactivity of      ogy and ­Venereology Department, Tanta University Hos-
the sympathetic nervous system after exclusion of other pa-       pitals. Patients were randomly allocated into two equal
thologies that result in diaphoresis. By contrast, secondary      groups; patients of group A were treated with topical oxy-
hyperhidrosis is attributable to an underlying cause as neu-      butynin 3% gel (liquid crystalline gel containing oleic acid
rologic, endocrine conditions, infectious, chronic diseases, or   20gm, tween eighty 30gm, ethanol 10gm, water 40gm and
medication side effects [2].                                      oxybutynin 3gm), and group B with aluminum chloride
    In terms of social, psychological, professional, and emo-     15% lotion. All patients were instructed to apply the treat-
tional aspects, hyperhidrosis is quite embarrassing. The          ment once daily, at night (when sweating is diminished) for
degree of impairment of quality of life is similar to that re-    4 weeks (adequate period for the optimal response of the
ported in chronic conditions including severe psoriasis and       topically applied drug to occur). Treatment was applied on
kidney failure [3]. The unpredictable and uncontrollable          the skin for 6 to 8 hours and was washed off in the next
nature of the condition makes it very distressing for suf-        morning with avoiding contact of the gel or the lotion with
ferers [4].                                                       the eyes, nose and mouth.
    Typically, primary hyperhidrosis treatment follows an            The study was declared for Ethical and Research ap-
incremental, stepwise approach from less invasive therapies       proval by Tanta University Institutional Review Broad,
(eg, aluminum chloride and iontophoresis) to more invasive        approval code no: 34256 / 11 / 20. An informed written con-
treatments such as botulinum toxin-A injection, oral anti-        sent was obtained from all patients before the study.
cholinergics or surgery. These treatments, however, have             Exclusion criteria were the presence of bacterial or viral
various limitations due to their inability to penetrate thick     infection at treated area, history of sensitivity to aluminum
epidermal layers (topical treatments on palmoplantar areas),      salts, history of hyperthyroidism or diabetes mellitus, other
pain (injections), skin irritability (topical treatments on ax-   inflammatory or genetic skin diseases affecting the treated
illary areas) or systemic effects (oral therapies and invasive    area (eg eczema, psoriasis or keratoderma), pregnancy, lac-
treatments) [5].                                                  tation and medications that induce hyperhidrosis as cholin-
    Topical treatment is the first recommendation because it      esterase inhibitors, selective serotonin reuptake inhibitors,
is safe, cost-effective and non-invasive. Aluminum chloride       opioids or tricyclic antidepressants.
can cause skin irritation due to formation of hydrochloric           All patients were subjected to full history taking (present,
acid in the presence of water [6]. Oxybutynin, a small ter-       past history and family history of hyperhidrosis), general and
tiary amine molecule, is well suited for use as a transdermal     full dermatological examination and laboratory investiga-
agent. The unionized free base form predominates at phys-         tions including thyroid function tests and hemoglobin A1C.
iologic pH. Its serum half-life is 62-84 hours when applied          Assessment of the severity of hyperhidrosis at the affected
topically suggesting that treatment may have a longer dura-       site and the efficacy of the treatment used was done through:
tion of action than existing topical therapies as aluminum
chloride [7].                                                     • Minor iodine starch test [8]: After cleaning the affected
                                                                    area, povidone-iodine solution was applied to dry skin

Objectives                                                          and allowed to dry. A thin layer of starch powder was
                                                                    applied to the painted area. The test was monitored un-
To compare the efficacy of topical oxybutynin 3% gel versus         til formation of purplish sediment in the evaluated area.
aluminum chloride 15% lotion in treatment of primary focal          Different intensities of sweating were identified and re-
hyperhidrosis.                                                      corded using digital photographs with 48 and 5-mega




2                                                                     Original Article | Dermatol Pract Concept. 2023;13(3):e2023192
  pixel dual camera (Oppo F11, 2019), at baseline and after        (minimum and maximum), mean, standard deviation, me-
  2 and 4 weeks of treatment, then 1 month after stopping          dian and interquartile range (IQR). Significance of the ob-
  treatment for follow up assessment (a proper period for          tained results was considered at 0.05.
  evaluation of the long term effect of the topically applied
  drug and to re-initiate therapy for patients who had re-
                                                                   Results
  currence thereafter). All photographs were graded by 2
  blinded dermatologists by giving points to represent the         The demographic data of patients of both groups are sum-
  degree of improvement as: 0 = no improvement, 1= minor           marized in Table 1. Evaluation of the degree of improvement
  improvement of < 25%, 2 = moderate improvement of                of both groups according Minor iodine starch test, HDSS
  26 - less than 50%, 3 = major improvement of 51- less            and DLQI at different periods of evaluation is summarized
  than 75%, 4= <75% improvement. Finally, the mean of              in Table 2 and Figure 1.
  the two evaluators scores was calculated at each time of             Regarding Minor test; in group A, the best degree of
  evaluation.                                                      improvement was at the fourth week. Meanwhile in group
• Hyperhidrosis disease severity scale (HDSS) [9]: Patients        B, the best degree of improvement was at the second week
  were asked to rate the condition severity by HDSS at base-       (Figures 1A, 2 and 3).
  line. A score of 1 indicated mild hyperhidrosis, 2 indicated         Regarding HDSS; in group A, the best level of decline
  moderate hyperhidrosis, and 3 or more (3 or 4) indicated         of HDSS was at the fourth week. While in group B, HDSS
  severe hyperhidrosis. Response to treatment was assessed         declined significantly at the second week and that decline
  by calculating the change in HDSS from baseline to weeks         continued at the fourth week with no significant difference
  2 and 4 then 1 month after stoppage of treatment. The            (Figure 1B).
  outcome was addressed by reduction of the HDSS by                    Regarding DLQI; in group A, there was a statistically
  points ranging from zero to 4 points.                            significant decline in DLQI score at the fourth week and at
• Dermatology life quality index (DLQI) [10]: Quality              1 month follow up. In group B, there was a statistically sig-
  of life was assessed with DLQI at baseline, at the end of        nificant decline in DLQI score at the fourth week but with
  treatment (after 4 weeks) and 1 month after stoppage of          no significant difference between baseline and 1 month fol-
  treatment.                                                       low up (Figure 1C).
                                                                       Comparison between the two studied groups according
Statistical Analysis                                               to Minor’s test, HDSS and DLQI at different periods of eval-
Data were fed to the computer and analyzed using IBM               uation is presented in Figure 4.
SPSS software package version 20.0. (IBM Corp). The                    Regarding Minor test, at the fourth week, group A
Shapiro-Wilk test was used to verify the normality of dis-         showed a statistically significant better improvement in
tribution. Qualitative data were described using number            comparison with group B. Both groups showed decline of
and percent. Quantitative data were described using range          improvement at 1 month follow up, but group A results were



   Table 1. Comparison between the two studied groups according to demographic data (Group A:
 treated by topical oxybutynin 3% gel. Group B: treated by topical aluminum chloride 15% lotion).
                                            Group A (N=20)       Group B (N=20)     Test of significance             P value
 Age; mean(SD)                                  15.8(5.3)          13.9(6.44)       U Mann Whitney test = 136.5       0.086
 Gender; N (%)
 - Male                                          8 (40%)            5 (25%)                    χ2= 1.026              0.31
 - Female                                       12 (60%)           15 (75%)
 Positive family history of                       8 (40)            11 (55)                    χ2= 0.902              0.34
 hyperhidrosis; N (%)
 Duration of hyperhydrosis (years);             7.7 (5.6)           6.4 (4.8)       U Mann Whitney test = 191         0.82
 mean(SD)
 Site of hyperhydrosis; N (%)
 - Palmar                                        12 (60)            11 (55)                    χ2=0.388               1.0
 - Plantar                                        7 (35)            8 (40)
 - Axillary                                        1 (5)             1 (5)

SD = standard deviation.




Original Article | Dermatol Pract Concept. 2023;13(3):e2023192                                                                 3
  Table 2. Evaluation of the degree of improvement of both studied groups according Minor iodine
starch test, hyperhidrosis disease severity scale and dermatology life quality index at different periods
                                              of evaluation.
       Degree of improvement
      according to Minor iodine                                                                   1 month
        starch test; mean (SD)               2 weeks                   4 weeks                   follow up           Fr         P value
 Group A (N=20)                             2.9 (1.25)                 3.7 (0.73)                2.7 (1.45)        17.59        <0.001
 Significance between periods                                P1=0.006, P2=0.693, P3=0.002
 Group B (N=20)                              2.9 (1.6)                 2.4 (1.9)                    0.6 (1.3)       19.9        >0.001
 Significance between periods                                P1=0.874, P2=0.002, P3=0.003
    Degree of reduction of HDSS;                                                                  1 month
             mean (SD)                       Baseline         2 weeks           4 weeks          follow up           Fr         P value
 Group A (N =20)                             3.7 (0.5)        1.8 (1.07)        0.9 (0.9)        2.1 (1.02)         48.9        <0.001
 P0                                                            <0.001            <0.001              0.003
 Significance between periods                                P1=0.017, P2=0.298, P3=0.001
 Group B (N =20)                             3.9 (0.3)         2.2 (1.2)        2.3 (1.5)           3.6 (0.9)       35.3        <0.001
 P0                                                            <0.001            <0.001              0.501
 Significance between periods                                P1=0.951, P2=0.002, P3=0.003
                                                                                                  1 month
          DLQI; mean (SD)                            Baseline                   4 weeks          follow up           Fr         P value
 Group A (N=20)                                      19.9 (3.8)                 1.6 (3.3)        5.05 (5.3)         37.3        <0.001
 P0                                                                                0.001             0.001
 P3                                                                                          0.014
 Group B (N=20)                                      21.2 (2.6)                 12.2 (7.8)       19.5 (4.5)         24.3        <0.001
 P0                                                                              0.001*              0.527
 P3                                                                                         0.006

Group A = treated by topical oxybutynin 3% gel; Group B = treated by topical aluminum chloride 15% lotion; Fr = Friedman test, ­Significance
between periods was done using post-hoc test (Dunn); SD = standard deviation; P = P value for comparing between the three studied periods,
P0 = P value for comparing between baseline and each other periods, P1 = P value for comparing between 2 weeks and 4 weeks, P2 = P value
for comparing between 2 weeks and 1 month follow-up, P3 = P value for comparing between 4 weeks and 1 month follow-up.




Figure 1. Comparison of the degree of improvement at different periods of evaluation. Group A treated with topical oxybutynin 3% gel.
Group B treated with topical aluminum chloride 15% lotion. (A) According to Minor test. (B) B according to hyperhidrosis disease severity
scale (HDSS). (C) According to Dermatology Life Quality Index (DLQI).




still significantly better (Figure 4A). Regarding HDSS, there           4 weeks of treatment (P <0.001) and at 1 month follow up
was a significantly lower HDSS in patients of group A than              (P value < 0.001) (Figure 4C).
in those of group B after 4 weeks of treatment (P = 0.004)                  Regarding side effects, no side effects were reported ex-
and at 1 month follow up (P >0.001) (Figure 4B). Regarding              cept for mild irritation and scaling in one patient (5%) in
DLQI, there was a significantly better score and less impact            group A and irritation with moderate dryness in another pa-
on patient’s quality of life in group A than group B, after             tient (5%) in group B.



4                                                                            Original Article | Dermatol Pract Concept. 2023;13(3):e2023192
      Figure 2. A 14- year old male patient with palmar hyperhidrosis of 2 years duration, group A, treated by topical oxybutynin
      3% gel. (A_D) Minor iodine starch test. (A) Before treatment. (B) After 2 weeks of treatment. (C) After 4 weeks of treatment,
      showing more than 75 % improvement. (D) At 1 month follow-up after stoppage of treatment, showing no recurrence.




      Figure 3. A 12-year old female patient with palmar hyperhidrosis of 5 years duration, group B, treated by topical aluminum
      chloride 15% lotion. (A-D) Minor iodine starch test. (A) Before treatment. (B) After 2 weeks of treatment (C) After 4 weeks of
      treatment, showing recurrence. (D) At 1 month follow-up after stoppage of treatment.



Original Article | Dermatol Pract Concept. 2023;13(3):e2023192                                                                         5
Figure 4. Comparison between the two studied groups at different periods of evaluation. Group A: treated by topical oxybutynin 3% gel,
group B: treated by topical aluminum chloride 15% lotion. A: according to Minor’s test. B: according to hyperhidrosis disease severity scale
(HDSS). C: according to dermatology life quality index (DLQI).




    Table 3. Correlation and relation between Minor test at 4 weeks of treatment and different patient
                                     parameters in both study groups.
                                                                                   Minor test at 4 weeks
                                                               Group A (N=20)                               Group B (N=20)
                                                       rs                      P                      rs                     P
 Age (years)                                        −0.367                  0.112                  0.349                   0.131
 Duration (years)                                   −0.149                  0.532                  −0.325                  0.163
                                                       n                  Mean(SD)                    n                 Mean(SD)
 Sex
 - Male                                                8                 3.75(0.71)                   5                  3.8(0.45)
 - Female                                              2                 3.67(0.78)                  15                 1.93(1.94)
 U, P                                                          U=46, P=0.910                               U=18.5, P=0.098
 Family history
 - Negative                                            12                3.67(0.78)                   9                 2.56(1.94)
 - Positive                                            8                 3.75(0.71)                  11                  2.27(1.9)
 U, P                                                           U=46, P=0.91                                 U=45, P=0.77
 Site of hyperhidrosis
 - Palmar                                              12                3.67(0.78)                  11                 2.73(1.85)
 - Plantar                                             7                    4(0.0)                    8                 1.88(2.03)
                                                           a                       a
 - Axillary                                            1                       2                      1                      3a
 U, P                                                           U=35, P=0.59                                U=32.5, P=0.4

Group A = treated by topical oxybutynin 3% gel; Group B = treated by topical aluminum chloride 15% lotion; R = Spearman coefficient;
SD = standard deviation; U = Mann Whitney test; P = P value for comparing between the different categories. a Excluded from the compar-
ison due to small number of case (N = 1).




     There was no statistically significant correlation between             Moreover, no statistically significant relations were de-
percentage of improvement in Minor test after 4 weeks of                tected between the percentage of improvement in Minor’s
treatment and either patient’s age or hyperhidrosis duration            test at 4 weeks of treatment and either the patient’s sex, fam-
in the two studied groups (Table 3).                                    ily history or hyperhidrosis site (Table 4).




6                                                                            Original Article | Dermatol Pract Concept. 2023;13(3):e2023192
        Table 4. Relation between Minor’s test at 4 weeks and different parameters in each group.
                                                                                Minor’s test at 4 weeks
                                                                   Group A                                  Group B
                                                    N                 Mean(SD)                   N              Mean(SD)
 Sex
 - Male                                              8                3.75(0.71)                  5              3.8(0.45)
 - Female                                            2                3.67(0.78)                 15             1.93(1.94)
 U, P                                                        U=46. P=0.910                             U=18.5, P=0.098
 Family history
 - Negative                                         12                3.67(0.78)                  9             2.56(1.94)
 - Positive                                          8                3.75(0.71)                 11              2.27(1.9)
 U, P                                                            U=46, P=0.91                             U=45, P=0.77
 Site of hyperhidrosis
 - Palmar                                           12                3.67(0.78)                 11             2.73(1.85)
 - Plantar                                           7                  4(0.0)                    8             1.88(2.03)
 - Axillary                                          1#                   2#                      1                 3#
 U, P                                                                U=35, P=0.59                             U=32.5, P=0.4

Group A: treated by topical oxybutynin 3% gel. Group B: treated by topical aluminum chloride 15% lotion. SD: Standard deviation.
U: Mann Whitney test. P: P value for comparing between the different categories. #: Excluded from the comparison due to small number of
case (n = 1).



Discussion                                                             treatment) in the present study are near to those in several
                                                                       previous studies investigating lines of treatment of hyperhi-
Regarding the site of hyperhidrosis in the present study, pal-         drosis [6,7].
mar hyperhidrosis was the most predominant with a per-                    Regarding the treatment outcome in the present study,
centage of 60% and 55% in groups A and B respectively,                 oxybutynin 3% gel achieved statistically significant better
followed by plantar hyperhidrosis with a percentage of 35%             outcome than aluminum chloride 15% lotion in reducing
in groups A and 40% in group B. This was in contrast to                hyperhidrosis symptoms after 4 weeks of treatment accord-
the study carried out by Artzi et al in which axillary hyper-          ing to Minor test, HDSS and DLQI. It was noted that none
hidrosis was most predominant (38%) [10]. Many authors                 of the patients in group A showed failed treatment, whereas
reported that axillary hyperhidrosis has the highest incidence         20% of group B patients failed to respond to aluminum
among primary focal hyperhidrosis patients [9,11,12]. The              chloride lotion.
higher prevalence of palmar hyperhidrosis in our study could              The response obtained from oxybutynin gel was sus-
be explained by the young age of the patients (5-28 years)             tained, even improved, throughout the 4 weeks of treatment
in whom excessive hand sweating might hinder their daily               in 100% of patients of group A. This was in contrast to the
scholar and life activities. Moraites et al [11] and Wolosker          response to aluminum chloride lotion which showed dimin-
et al [13] suggested that when the condition occurs in pre-            ishing efficacy after 2 weeks and potential recurrence of hy-
pubertal individuals, the palmar or plantar variety generally          perhidrosis symptoms despite continued treatment in 15%
manifests (88.9%), with less presentations in the axillary             of patients of group B.
(15.5%), facial (6.6%), abdominal and dorsal (4.4%) re-                   The superiority of oxybutynin over aluminum chloride
gions. Moreover, in our culture, palmar and plantar hyper-             may be explained by its relatively longer half-life which ex-
hidrosis were of more concern to patients secondary to their           tends to 84 hours when applied topically and hence it has a
impact on quality of life in contrary to axillary hyperhidrosis        longer duration of action [14]. On the other hand, the su-
which is usually perceived as an extreme physiological form            perficial plugs formed by aluminum chloride in the distal
of sweating.                                                           eccrine sweat gland ducts are thought to remain in place for
    In the present study, oxybutynin gel was used in a con-            around 24 hours and to be washed away over time, when
centration of 3% was to ach optimal tolerability and lower             the sweat output returns. Therefore, re-application was pre-
side effects.                                                          viously recommended for maintenance of its effect [15].
    It should be noted that the duration of treatment                     The results of oxybutynin gel in the present study came
(4 weeks) and follow up (additional 4 weeks after the end of           in accordance with those of Artzi et al [10] who evaluated




Original Article | Dermatol Pract Concept. 2023;13(3):e2023192                                                                       7
the efficacy of twice daily application of oxybutynin 10%        application aluminum chloride lotion, just before sleep
gel versus placebo in treatment of primary focal hyperhidro-     (when sweat is at its lowest level) to be washed off after 6 to
sis (palmar, plantar or axillary). They reported a significant   8 hours. This should result in efficient plug formation, limit
sweat reduction in the drug-treated areas in comparison with     skin irritation, increase efficacy, and limit clothing damage
placebo-treated areas with a statistically significant mean      [1,19,20].
improvement in HDSS and DQLI pre- and post-treatment                Regarding the drug concentration, the current study
(P = 0.001 for both). Seventy four percent of their patients     showed that oxybutynin 3% gel had comparable efficacy to
reported moderate-to-high satisfaction.                          the 10% gel used in the study conducted by Artzi et alat
    In a similar context, the study conducted by Nguyen et al    the application sites [10]. However, the higher concentration
reported that a daily application of oxybutynin 3% gel re-       might be associated with higher systemic absorption and
duced primary axillary hyperhidrosis symptoms according          hence better efficacy at distant untreated sites. The effect on
to the HDSS in all included seven patients [7]. Also, DLQI       distant sites was not evaluated in the current study and could
scores improved in all patients who completed the study.         be an area of potential future research.
They also reported that all patients with concurrent palmo-         Regarding the adverse events in the present study, no re-
plantar hyperhidrosis experienced improvement in at least        markable side effects were reported in the two groups ex-
one untreated site and that could be attributed to the passive   cept for mild irritation, scaling and dryness in only 5% of
diffusion of the gel across the stratum corneum and its sys-     cases. No systemic adverse events were noted, and no serious
temic absorption [10].                                           adverse effects that led to withdrawal from the study were
    Regarding aluminum chloride lotion, several studies          encountered.
reported its efficacy in the treatment of primary focal             In a previous study, the use of oxybutynin 10% gel was
hyperhidrosis (axillary, palmar and plantar) with con-           associated with transient headaches in the first week in
centrations ranging from 6.25% to 40% and several in-            3.8% of patients, 47.8% of axillary hyperhidrosis patients
vestigators consider aluminum chloride hexahydrate in            reported erythema and pruritus, 50% of plantar hyperhi-
alcohol solution as the first-line treatment for axillary        drosis patients reported that the product was “sticky” and
hyperhidrosis [16-18].                                           unpleasant to use and 11.3% of the patient population
    On the other hand, some authors declared that alumi-         withdrew from the study secondary to adverse effects [10].
num chloride might be less rewarding in palmar and plantar       The higher incidence of adverse effects in comparison with
hyperhidrosis than in axillary hyperhidrosis and they sug-       the present study might be related to higher concentration
gested that if aluminum chloride solutions are to be used on     of the gel used.
the palms or soles, the concentration must be raised up to          In a previous small pilot study carried out on 10 pa-
30% [1,16,19]. This could explain the lower efficacy of alu-     tients with severe axillary hyperhidrosis who were treated
minum chloride noted in the current study as cases of palmar     with topical oxybutynin 3% gel, 7 patients completed the
and plantar hyperhidrosis were most predominant and the          study and 33.3% of them experienced mild systemic ad-
used concentration was 15%. Some authors suggested that          verse event; where 22.2% reported xerostomia during the
if aluminum chloride solutions are to be used on the palms       first week, and 11.1% reported constipation and blurry
or soles, the concentration must be raised up to 30% [1,16].     vision which was associated with opioid use after elective
In contrast, a previous study showed that aluminum chloride      surgery and probably not related to the study drug [7].
12.5% was as effective as 30% for the treatment of plantar       The authors recommended further large, prospective,
hyperhidrosis [17].                                              placebo-controlled studies to assess safety and efficacy of
    Regarding the frequency of treatment application, the        oxybutynin 3% gel.
current study showed that only once nightly application             Regarding aluminum chloride lotion, it has been previ-
of oxybutynin gel 3% was effective with comparable re-           ously reported that skin irritation and most adverse effects
sults to the twice daily application (morning and evening)       were correlated with higher concentrations [1] which were
adopted by Artzi et al in reducing over sweating at the          avoided by the use of 15% lotion in the current study.
application sites [10]. This suggested that morning appli-          The present study had some limitations including the
cation might be of limited value and that night-time ap-         relatively small sample size, being a single center study, in
plication was more effective due to the low sweat output         addition to the short period of patients follow-up. There-
during sleep which allowed the drug to remain in place           fore, more studies with larger sample size on different types
with longer contact duration and better diffusion into the       of focal hyperhidrosis, whether affecting one site or several
sweat glands.                                                    sites at the same time, are recommended to evaluate the ef-
    Similarly and in accordance with application regimen in      fect and safety of oxybutynin gel and its influence on distant
the current study, many authors recommended a night-time         untreated sites.



8                                                                    Original Article | Dermatol Pract Concept. 2023;13(3):e2023192
Conclusions                                                              8. Hexsel D, Rodrigues TC, Soirefmann M, Zechmeister-Prado D.
                                                                            Recommendations for performing and evaluating the results
Oxybutynin 3% gel tended to reduce hyperhidrosis severity                   of the minor test according to a sweating intensity visual scale.
                                                                            Dermatol Surg. 2010;36(1):120-122. DOI: 10.1111/j.1524-
and improve quality of life in patients with primary focal
                                                                            4725.2009.01364.x. PMID: 19930398.
hyperhidrosis. It might be more effective than aluminum                  9. Nawrocki S, Cha J. The etiology, diagnosis, and management
chloride 15% lotion at relieving hyperhidrosis symptoms                     of hyperhidrosis: A comprehensive review: Etiology and clini-
with no tachyphylaxis and lower recurrence rate after stop-                 cal work-up. J Am Acad Dermatol. 2019;81(3):657-666. DOI:
page of treatment and minor side effects. Hence, it should be               10.1016/j.jaad.2018.12.071. PMID: 30710604.
considered as a possible added efficient topical treatment for          10. Artzi O, Loizides C, Zur E, Sprecher E. Topical Oxybutynin
                                                                            10% Gel for the Treatment of Primary Focal Hyperhidrosis:
primary focal hyperhidrosis besides topical aluminum chlo-
                                                                            A Randomized Double-blind Placebo-controlled Split Area
ride. Further studies on oxybutynin gel on a larger number                  Study. Acta Derm Venereol. 2017;97(9):1120-4112. DOI:
of patients and for longer duration of follow up are needed                 10.2340/00015555-2731. PMID: 28654131.
to confirm its efficacy and safety in treatment of primary              11. Moraites E, Vaughn OA, Hill S. Incidence and prevalence of
focal hyperhidrosis.                                                        hyperhidrosis. Dermatol Clin. 2014;32(4):457-465. DOI:
                                                                            10.1016/j.det.2014.06.006. PMID: 25152338.
                                                                        12. Augustin M, Radtke MA, Herberger K, Kornek T, Heigel H,
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Original Article | Dermatol Pract Concept. 2023;13(3):e2023192                                                                                9
