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A 1% glycopyrronium bromide cream for the topical treatment of primary axillary hyperhidrosis: Efficacy and Safety Results from a Phase 3a Randomised Controlled Study.

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A 1% glycopyrronium bromide cream for the topical treatment of primary axillary hyperhidrosis: Efficacy and Safety Results from a Phase 3a Randomised Controlled Study.

Br J Dermatol. 2021 Jan 14;:

Authors: Abels C, Soeberdt M, Kilic A, Reich H, Knie U, Jourdan C, Schramm K, Heimstaedt-Muskett S, Masur C, Szeimies RM

Abstract
BACKGROUND: Effective topical treatment options for patients with primary axillary hyperhidrosis are limited. Recent phase 1 trial showed promising results regarding efficacy and safety for topical cream containing glycopyrronium bromide (GPB).
OBJECTIVE: To assess efficacy, safety and tolerability of a 4-week topical treatment with 1% GPB cream in subjects with primary axillary hyperhidrosis compared to placebo.
METHODS: 171 patients (84 placebo; 87 1% GPB) with primary axillary hyperhidrosis were included in this 4 week, multicenter, randomised, double-blind, placebo-controlled Phase 3a part of the pivotal study. Sweat production was measured by gravimetry. Patients rated disease impact using the Hyperhidrosis Disease Severity Scale (HDSS) and Hyperhidrosis Quality of Life Index (HidroQoL© ).
RESULTS: Absolute change in sweat production from baseline to day 29 in logarithmic values was significantly larger in the 1% GPB group than in the placebo group (p=0.0038). The improvement in HidroQoL© exceeded minimal clinically important difference of 4. The proportion of responders was two-fold higher than for placebo for sweat reduction, HDSS and HidroQoL© (-197.08 mg GPB vs. -83.49 mg placebo; 23% GPB vs 11.9% placebo and 59.8% GPB vs. 26.2% placebo respectively). Treatment was safe, most TEAEs were mild or moderate and transient. Local tolerability was very good with 9.2% of patients having only mild or moderate application site reactions. The most reported ADR was dry mouth (16.1%), an expected anticholinergic effect of the treatment.
CONCLUSION: 1% GPB cream may provide an effective new treatment option exhibiting a good safety profile for patients with primary axillary hyperhidrosis. The long-term open-label part (Phase 3b) is ongoing.

PMID: 33445205 [PubMed – as supplied by publisher]

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Lumbar Sympathetic Nerve Modulation Using Absolute Ethanol for the Treatment of Primary Lower-Extremity Hyperhidrosis: A Dose-Effect Pilot Study.

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Lumbar Sympathetic Nerve Modulation Using Absolute Ethanol for the Treatment of Primary Lower-Extremity Hyperhidrosis: A Dose-Effect Pilot Study.

Med Sci Monit. 2021 Jan 12;27:e928209

Authors: Liu M, Ni H, Tao J, Xie K

Abstract
BACKGROUND Primary lower-extremity hyperhidrosis (PLEH) can be treated by CT-guided lumbar sympathetic nerve modulation using absolute ethanol. However, doses of ethanol that are too high can cause nerve injury, and doses that are too low have suboptimal results. The present study aimed to investigate the dose-effect relationship of CT-guided lumbar sympathetic nerve modulation with absolute ethanol for PLEH. MATERIAL AND METHODS The study was conducted at the First Affiliated Hospital of Jiaxing University between 07/2014 and 02/2017. Twenty participants were enrolled in each group. The doses of absolute ethanol were 2.0 ml in the R₁ group, 2.5 ml in the R₂ group, 3.0 ml in the R₃ group, 3.5 ml in the R₄ group, and 4.0 ml in the R₅ group. Treatment effectiveness was assessed according to the time to complete hyperhidrosis relief: <10 min, effective; ≥10 min, non-effective. RESULTS The patient characteristics among the 5 groups were not statistically different (P>0.05). The onset time and time to complete hyperhidrosis relief decreased significantly with increasing dose of absolute ethanol (P<0.05). The effective rates in the 5 groups were 15.0%, 35.0%, 60.0%, 90.0%, and 100.0%, respectively. The ED₅₀ and ED₉₅ were 2.306 ml (95% CI: 2.003-2.512 ml) and 3.343 ml (95% CI: 3.051-3.962 ml), respectively. CONCLUSIONS This was the first dose-effect pilot study of consecutive PLEH patients treated by CT-guided lumbar sympathetic nerve modulation. CT-guided lumbar sympathetic nerve modulation with 2.306 ml (ED₅₀) and 3.343 ml (ED₉₅) of absolute ethanol showed treatment efficacy for PLEH. No complications were seen.

PMID: 33434188 [PubMed – in process]

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Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis.

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Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis.

Clin Pharmacokinet. 2021 Jan 12;:

Authors: Pariser DM, Lain EL, Mamelok RD, Drew J, Mould DR

Abstract
BACKGROUND: Glycopyrronium tosylate (GT; Qbrexza® [glycopyrronium] cloth, 2.4%) is a topical anticholinergic approved (USA) for primary axillary hyperhidrosis in patients aged ≥ 9 years.
OBJECTIVE: The objective of this study was to compare the pharmacokinetics and safety of GT to oral glycopyrrolate (phase I study) and assess the relationship between glycopyrronium pharmacokinetics and anticholinergic-related adverse events or efficacy with population pharmacokinetics using data from two phase II studies.
METHODS: In the phase I study, study staff applied GT to axillae of patients with primary axillary hyperhidrosis (aged 9-65 years) once daily (5 days); oral glycopyrrolate was administered to healthy adults (aged 18-65 years) every 8 hours (15 days). In the phase II studies (NCT02016885 [20 December, 2013], NCT02129660 [2 May, 2014]), adults with primary axillary hyperhidrosis applied topical glycopyrronium (0.8-3.2%) or vehicle to axillae once daily (4 weeks). Pharmacokinetic and adverse event data were collected in all studies.
RESULTS: Glycopyrronium pharmacokinetic parameters were similar between adult and pediatric patients treated with GT; there was no evidence of accumulation. Systemic absorption of glycopyrronium was lower with GT vs oral glycopyrrolate. No anticholinergic-related adverse events occurred with GT in the phase I study, while dry mouth and nasal dryness occurred with oral glycopyrrolate; anticholinergic adverse events occurred in the phase II studies. In the population pharmacokinetic analysis, frequency/severity of anticholinergic-related adverse events increased with higher glycopyrronium concentration; no relationship was observed between efficacy and pharmacokinetic measures.
CONCLUSIONS: These studies indicate limited absorption of GT compared to oral glycopyrrolate and a low risk of anticholinergic adverse events with proper GT administration when following instructions for use (wipe each underarm once with same cloth, wash hands, avoid ocular contact).

PMID: 33433785 [PubMed – as supplied by publisher]

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A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis.

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A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis.

J Dermatol. 2021 Jan 07;:

Authors: Yokozeki H, Fujimoto T, Abe Y, Igarashi M, Ishikoh A, Omi T, Kanda H, Kitahara H, Kinoshita M, Nakasu I, Hattori N, Horiuchi Y, Maruyama R, Mizutani H, Murakami Y, Watanabe C, Kume A, Hanafusa T, Hamaguchi M, Yoshioka A, Egami Y, Matsuo K, Matsuda T, Akamatsu M, Yorozuya T, Takayama S

Abstract
A phase 3 study was conducted to verify the efficacy and safety of 5% sofpironium bromide (BBI-4000) gel (hereinafter referred to as sofpironium) administrated for 6 weeks in Japanese patients with primary axillary hyperhidrosis. The primary efficacy end-point was the proportion of patients who satisfied both criteria of a Hyperhidrosis Disease Severity Score (HDSS) of 1 or 2 at the end of 6-week treatment and a 50% or more reduction in total gravimetric weight of sweat at the end of treatment relative to baseline. A total of 281 patients were randomized to receive 5% sofpironium (141 patients) or vehicle (140 patients), and all patients were included in the full analysis set (FAS). In the FAS, 70.1% of patients were female, and the median age was 35.0 years. The proportion of patients who achieved the primary efficacy end-point was 53.9% in the sofpironium group and 36.4% in the vehicle group, with a statistically significant difference of 17.5% (95% confidence interval, 6.02-28.93) between these two groups (P = 0.003). The incidence of adverse events was 44.0% in the sofpironium group and 30.7% in the vehicle group, and the incidence of adverse drug reactions was 16.3% in the sofpironium group and 5.0% in the vehicle group. Reported adverse events were generally mild or moderate in severity. In the sofpironium group, common events (incidence, ≥5%) were nasopharyngitis (14.2%) and dermatitis/erythema at the application site (8.5%/5.7%), with no serious adverse events reported. This study demonstrated the efficacy and safety of 5% sofpironium.

PMID: 33410265 [PubMed – as supplied by publisher]

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Does the Sweating Severity of Primary Hyperhidrosis Sites Affect Post-Sympathotomy Results?

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Does the Sweating Severity of Primary Hyperhidrosis Sites Affect Post-Sympathotomy Results?

Thorac Cardiovasc Surg. 2020 Dec 24;:

Authors: Çınar HU, Çelik B

Abstract
BACKGROUND:  Improvement in quality of life (QOL) and patient satisfaction after endoscopic thoracic sympathotomy (ETS) in patients with primary hyperhidrosis may be affected by various factors. We examined whether the preoperative sweating severity of primary hyperhidrosis sites affects postoperative results.
METHODS:  The records of 112 patients who underwent bilateral ETS were reviewed retrospectively. The patients were divided into three groups according to the sweating severity score obtained from all primary hyperhidrosis sites (primary hyperhidrosis severity score [PHSS]) and analyzed comparatively. Group A (PHSS = 1-4) included 22 patients, Group B (PHSS = 5-8) 36 patients, and Group C (PHSS ≥ 9) 54 patients. Outcome measures included QOL prior to surgery, improvement in QOL after surgery, degree of clinical improvement, presence, severity, localization, and site number of reflex sweating (RS) and general patient satisfaction after 6 months of surgery.
RESULTS:  The preoperative QOL of patients with higher PHSS (groups B, C) was worse than other patients (group A). More than 91% of all patients had any level improvement in QOL, and over 96% had slight or great clinical improvement. RS developed in 80% of the patients, mostly in the back, very severe in 8%, and in median two different body areas. The overall patient satisfaction rate was more than 95%. There was no significant difference between the three groups in terms of all postoperative results.
CONCLUSION:  Preoperative sweating severity of primary hyperhidrosis sites does not affect post-sympathotomy results. Surgeons should not be worried when deciding upon surgery, even in patients with high sweating severity.

PMID: 33368108 [PubMed – as supplied by publisher]

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CT-assisted thoracic sympathicolysis for therapy of primary hyperhidrosis palmaris-retrospective analysis of the influence of the amount and position of the sympathetic agent on the therapeutic outcome and side effects.

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CT-assisted thoracic sympathicolysis for therapy of primary hyperhidrosis palmaris-retrospective analysis of the influence of the amount and position of the sympathetic agent on the therapeutic outcome and side effects.

Rofo. 2020 Dec 21;:

Authors: Andresen JR, Scheer F, Schlöricke E, Andresen R

Abstract
PURPOSE:  The objective of the present study was to evaluate the benefit of a thoracic, computed tomography-guided sympathicolysis (CTSy) in patients with primary, focal hyperhidrosis of the hands. In addition, the influence of the amount and distribution of the administered sympathicolytic agent was to be assessed.
PATIENTS AND METHODS:  Retrospectively, 78 patients [13 (16.7 %) men, mean age 31.2 ± 9 years and 65 (83.3 %) women, mean age 34.2 ± 12 years], who had been treated using CTSy, were included in the study. The indication for treatment was primary focal palmar hyperhidrosis grade II and grade III after exhaustion of all conservative treatment options and a continued high level of suffering. CTSy was performed after establishing the entry plane at the level of the intervertebral space T2 / T3 via a dorsolateral approach using a 22-G coaxial needle. On average 5 (2-10) ml of a sympathicolytic mixture (10 ml consisting of 8 ml 96 % alcohol, 1.6 ml 0.5 % Carbostesin and 0.4 ml 0.9 % NaCl solution, with added amounts of contrast medium) were instilled. The volume of distribution of the sympathicolytic agent was determined in craniocaudal direction using CT images. The patients evaluated their sense of discomfort preinterventionally, 2 days postinterventionally, and 6 and 12 months after the intervention, on the basis of a Dermatology life Quality Index (DLQI) as well as the side effects that occurred.
RESULTS:  The technical success rate of CTSy was 100 %. No major complications occurred. The interventions performed led to a significant reduction (p < 0.001) in the preinterventional sense of discomfort 2 days, 6 and 12 months after CTSy. As the most common side effect, compensatory sweating was reported by 16/78 (20.5 %) of the patients over the further course. In all of these patients, the volume of sympathicolytic agent administered was below 5 ml. In no case did the sympathicolytic agent extend caudally beyond the base plate of Th 3. No compensatory sweating of the back was observed in 5/78 (6.4 %) patients; here the sympathicolytic volume was above 5 ml and extended significantly caudally below the baseplate of T3.Transient miosis and ptosis was found in 8/78 (10.3 %) patients. In all of these patients, the volume of sympathicolytic agent administered was above 5 ml and it extended markedly cranially beyond the upper plate of T2. A mild to moderate recurrent sweating developed in 35/78 (44.9 %) patients, which was more marked if the volume of sympathicolytic administered was below 5 ml and slightly more pronounced on the left than on the right. Given a high level of satisfaction overall, 71/78 (91.0 %) patients said that they would undergo the intervention again.
CONCLUSION:  For patients with primary, focal palmar hyperhidrosis CTSy represents a therapeutic option that offers good benefit and has few side effects. The amount and spatial distribution of the sympathicolytic agent has an influence on the therapeutic outcome and the side effects.
KEY POINTS: · CT-assisted thoracic sympathicolysis is a minimally invasive, low-complication therapy for treatment of severe forms of primary hyperhidrosis palmaris.. · CT-assisted thoracic sympathicolysis can usually be performed on an outpatient basis.. · The quantity and local distribution of the sympathicolytic agent has an influence on the therapeutic outcome and the side effects..
CITATION FORMAT: · Andresen J, Scheer F, Schlöricke E et al. CT-assisted thoracic sympathicolysis for therapy of primary hyperhidrosis palmaris-retrospective analysis of the influence of the amount and position of the sympathetic agent on the therapeutic outcome and side effects. Fortschr Röntgenstr 2020; DOI: 10.1055/a-1299-2098.

PMID: 33348382 [PubMed – as supplied by publisher]

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Fractional CO2 Laser for Transcutaneous Drug Delivery of Onabotulinum Toxin in Palmar Hyperhidrosis.

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Fractional CO2 Laser for Transcutaneous Drug Delivery of Onabotulinum Toxin in Palmar Hyperhidrosis.

Dermatol Surg. 2020 Dec 15;Publish Ahead of Print:

Authors: Agamia NF, Sobhy N, Abd-Elraouf A, Tawfik A

Abstract
BACKGROUND: Palmar hyperhidrosis is a common disorder of excessive sweating due to over-stimulation of cholinergic receptors on eccrine glands.
OBJECTIVE: To compare the efficacy of laser-assisted drug delivery of onabotulinum toxin A (BoNTA) and intradermal BoNTA injections in the management of palmar hyperhidrosis.
PATIENTS AND METHODS: This intrapatient comparative study was conducted on 30 adult patients with idiopathic palmar hyperhidrosis. The palms of the patients were divided into 2 groups. Group 1 was treated with intradermal injections of 50 units of BoNTA, whereas Group 2 was subjected to laser-assisted transcutaneous BoNTA delivery using fractional CO2 laser at different doses (25, 50, and 75 units). Each treatment modality was evaluated using the iodine starch test, hyperhidrosis disease severity scale, and gravimetric scoring.
RESULTS: Delivery of 75 units of BoNTA to the dermis on the right-sided palms assisted by fractional CO2 laser was clinically equivalent to 50 units of injection on the left side. Pain intensity was significantly higher on the injected side than on the other side.
CONCLUSION: Laser-assisted drug delivery of botulinum toxin can be considered an effective and safe alternative for treatment of palmar hyperhidrosis with minimal side effects and complications.

PMID: 33337732 [PubMed – as supplied by publisher]

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Efficacy of Photodynamic Therapy for Treatment of Primary Palmar Hyperhidrosis.

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Efficacy of Photodynamic Therapy for Treatment of Primary Palmar Hyperhidrosis.

Dermatol Ther. 2020 Dec 10;:

Authors: Shabaik AH, Shaheen MA, Soltan MY

Abstract
BACKGROUND: Palmar hyperhidrosis represents a condition with a significant cosmetic and psychological burden. Various treatment modalities are available; however, searching for newer options to meet patients’ needs and expectations is encouraged.
AIM: The study aimed to evaluate the efficacy of photodynamic therapy (PDT) for treatment of primary palmar hyperhidrosis. Two different photosensitizers for PDT were evaluated: eosin Y, and methylene blue. The study focused on the clinical efficacy, patient’s satisfaction, and the time & number of sessions needed to achieve a satisfactory response.
METHODS: Twenty patients with primary palmar hyperhidrosis were enrolled in a single-center clinical study. Patients were treated with PDT for a maximum of eight sessions. Two photosensitizers were tested: eosin Y, and methylene blue for the right and left hand, respectively. The Hyperhidrosis disease severity scale (HDSS), and Sweating Intensity Visual Scale of Minor’s test were used for assessment.
RESULTS: Photodynamic therapy effectively reduced the severity scores of hyperhidrosis with comparable results between the two photosensitizers. The treatment effect was maintained up to three months after the last procedure.
CONCLUSION: Photodynamic therapy is a good treatment option for primary palmar hyperhidrosis with results maintainable for three months after the treatment end.

PMID: 33301218 [PubMed – as supplied by publisher]

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Craniofacial hyperhidrosis: clinical characteristics and response to treatment in a cohort of 97 patients treated with oral oxybutynin.

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Craniofacial hyperhidrosis: clinical characteristics and response to treatment in a cohort of 97 patients treated with oral oxybutynin.

Dermatol Ther. 2020 Dec 10;:

Authors: García-Souto F, Del Boz J, Colmenero-Sendra M, Polo-Padillo J

Abstract
The term craniofacial hyperhidrosis (HH) refers to HH that affects the face and/or scalp. Few studies have focused on this specific location, and even fewer distinguish between the two areas. Our study aims are to describe the clinical characteristics of patients with craniofacial HH, specifying whether the condition affects the scalp, face or both, and to compare these cases with those recorded at other locations. As secondary objectives, we determine the effectiveness and adverse effects of oral oxybutynin (OOx), and assess patients’ adherence to treatment. This prospective observational study was carried out with respect to the period 2007-2019. All patients diagnosed with HH of the scalp and/or face and who were treated with OOx at our HH unit were included in the study group. Of 292 patients treated with OOx, 97 (33.2%) had craniofacial HH. Of these, four (4.1%) presented HH exclusively on the scalp, 56 (57.7%) exclusively on the face and 37 (38.1%) in both locations. The patients in the latter category (compared to those with exclusively facial HH) were significantly older than the others, had a later onset of HH, a greater frequency of secondary HH, less simultaneous involvement of the classical areas of primary focal HH (the palms, soles and armpits) and greater generalised HH and of the trunk. No significant differences were observed between the three locations (face, scalp or both) regarding the efficacy and side effects of OOx. The patients with exclusively facial HH presented greater adherence to treatment. This article is protected by copyright. All rights reserved.

PMID: 33301207 [PubMed – as supplied by publisher]