Efficacy and Safety of Glycopyrronium Bromide 1% Cream in Axillary and Extra-Axillary Primary Hyperhidrosis: A Real-Life Two-Center Experience on 68 Subjects

Abstract

Introduction: Primary hyperhidrosis (PH) is a common disorder affecting approximately 1% of the general population, characterized by focal sweating in excess of that required for normal temperature regulation without any associated condition. It is an embarrassing and disabling condition with a great impact on patients’ quality of life. Glycopyrronium bromide (GPB) 1% cream is a recently authorized topical pharmacological treatment for primary axillary PH. Although the efficacy of this treatment for axillary hyperhidrosis is well established, there are no clinical data regarding both efficacy and safety of GPB 1% cream when used in other body areas such as palm, plantar, and craniofacial regions (out-of-label use).

Materials and Methods: In this study, the real-life experience of two Italian tertiary center care dermatology clinics for treatment of PH with GPB 1% cream for both axillary and extra-axillary localizations has been reported. Patients suffering from PH were treated for 12 weeks. The treatment of the affected areas with GPB 1% cream consisted of once-daily application for 4 weeks (T4), followed by a reduced frequency of application over the following 8 weeks (T12). Main efficacy outcomes included assessment of change in the 4-point Hyperhidrosis Disease Severity Scale (HDSS) and the 36-point Hyperhidrosis Quality of Life Index (HidroQoL); axillary PH patients were also assessed for change in the 4-item Axillary Daily Sweating Diary (ASDD). Safety of use was assessed at both T4 and T12, through anamnestic collection of symptoms and direct patient observation.

Results: Patients with PH evaluated were 68 (39 female and 29 males with a mean age of 40 ± 16.0 years). Thirty-one subjects (45%) suffered from axillary PH, 10 subjects (15%) had multiple localizations (axilla and palmoplantar and axilla and craniofacial), 13 subjects showed only palmar involvement (19%), and 14 subjects experienced only craniofacial PH (21%). All subjects but 5 (7%) completed the 12-week treatment period. HDSS score before treatment was 3.54 ± 0.53, HidroQoL 27.874 ± 2.238.7, and ASDD (n = 31) 13.66 ± 1.5. The mean HDSS value was reduced significantly to 1.1 ± 0.45 at T4 (p = 0.001) and to 1.2 ± 0.50 at T12; the overall percentage of HDSS good responder patients (patients experiencing a reduction in HDSS of at least two points = reduction in sweating between 50% and 75% from baseline value) was 53% at T4 and 43% at T12, and the other patients were considered mild responders. HidroQoL was reduced to 8.18 ± 1.83(T4) and 9.05 ± 0.78 (T12) (p = 0.001). As expected, GPB 1% cream was highly effective in subjects with axillary PH considering the reduction in ASDD score to 2.1 ± 0.57 and 2.2 ± 0.65 at T4 and T12, respectively (p = 0.001). Considering the different localizations of hyperhidrosis separately, at T4, the percentage of patients experiencing a reduction in HDSS of at least two points was 76%, 30%, 55%, and 50% for axillary, palmar, craniofacial, and multiple localizations, respectively. At T12, the percentage of patients experiencing a reduction in HDSS of at least two points was 70%, 26%, 40%, and 35% for axillary, palmar, craniofacial, and multiple localizations, respectively. At T4, the treatment was effective also for multiple localizations (axilla and palmoplantar and axilla and craniofacial) and craniofacial PH, although the efficacy was lower in comparison with axillary PH (p = 0.01 for both comparisons) but higher than palmar hyperhidrosis (p = 0.05 at least). At T12, the treatment confirms its efficacy for multiple localizations and craniofacial PH, although with less efficacy than axillary PH (p = 0.001) and without any difference between body sites. The treatment was safe, and no adverse events emerged other than those expected. Two patients with craniofacial PH dropped out due to adverse events (transient blurred vision and urinary hesitancy).

Conclusion: Our real-life experience with GPB 1% cream confirmed that the treatment is very effective and safe in axillary PH. Moderate–good efficacy was observed also for PH involving craniofacial and multiple localizations (axilla and palmoplantar and axilla and craniofacial), while less efficacy was found in the treatment of palmar hyperhidrosis. The use of GPB 1% cream in the craniofacial region should be carried out with caution due to possible adverse events.