Botulinum Toxin Type B for Hidradenitis Suppurativa: A Randomised, Double-Blind, Placebo-Controlled Pilot Study.

BACKGROUND: Botulinum toxin (BTX) is a potent neurotoxin with a long history of therapeutic application in neurological and dermatological conditions, with a strong efficacy and safety profile. OBJECTIVE: Our aim was to assess whether intradermal injection with BTX-B is an effective treatment for hidradenitis suppurativa (HS). METHODS: Twenty patients with HS stage I-III disease, according to Hurley's classification, were consecutively included for treatment with either a placebo or BTX-B. At the next intervention after 3 months, all participants received the active substance and another follow-up at 6 months. The primary outcome was quality of life, measured using the Dermatology Life Quality Index (DLQI), while secondary outcomes were the visual analogue scale (VAS) for pain in the worst boil and HS-related impairment of general health (VAS), as well as changes in physician-reported disease activity assessed as the number of total lesions, and reported adverse effects of treatment. RESULTS: The DLQI improved from a median of 17 at baseline to 8 at 3 months in the BTX-B group, compared with a reduction from 13.5 to 11 in the placebo group (p <0.05). Improvement of the patients' own ratings of symptoms and a reduction in total lesions supplemented the primary outcome. Fifty-five percent of the study population reported some degree of hyperhidrosis. CONCLUSION: BTX-B improves the quality of life in patients with HS. Furthermore, comorbidity between HS and hyperhidrosis is suggested. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03103074.

Anxiety and Depression in Primary Hyperhidrosis: An Observational Study of 95 Consecutive Swedish Outpatients.

is missing (Short communication).

Postmenopausal craniofacial hyperhidrosis treated with botulinum toxin type B.

Hyperhidrosis can seriously impair patients' quality of life. Medical history, including heredity and hyperhidrosis during youth, as well as current age and time elapsed since menopause, is important to consider when distinguishing between postmenopausal hyperhidrosis and vasomotor symptoms to enable adequate treatment. This report concerns a subgroup of eight postmenopausal patients participating in a randomized controlled trial regarding botulinum toxin (Btx) type B treatment in craniofacial hyperhidrosis. Even though the sample size is small and the enrolment is not yet completed, the promising data collected hitherto are interesting to present in advance because this subtype of craniofacial hyperhidrosis is often underrecognized and challenging to treat. Patients were randomized to receive Btx type B or placebo. Measurements were performed before treatment and 3 ± 1 weeks after. The Dermatology Life Quality Index (DLQI) score was improved for all patients after Btx type B treatment (n = 3) with a median decrease of 9 points (90% median improvement). The placebo group (n = 5) had a median increase of 2 points (-18% median decline). When the same group (n = 5) received Btx type B (open) the DLQI score decreased with a median of 7 points compared with baseline (91% median improvement). Treatment-related adverse events were temporary and did not prevent improvement of life quality. Furthermore, background data evaluation uncovered interesting findings regarding vasomotor symptoms in relation to postmenopausal hyperhidrosis. In conclusion, the results indicated that Btx type B seems to be a safe and effective treatment in postmenopausal craniofacial hyperhidrosis. Further research is encouraged.

Hyperhidrosis Substantially Reduces Quality of Life in Children: A Retrospective Study Describing Symptoms, Consequences and Treatment with Botulinum Toxin.

Studies on children with hyperhidrosis are sparse. This retrospective study presents clinical data and quality of life, along with treatment effect and safety of botulinum toxin (BTX). Case reports from 366 children were included to capture the medical history of hyperhidrosis. The total median score of the Dermatology Life Quality Index before treatment was 11 for children aged 16-17 years and 12 for children younger than 16 years. The children described physical, psychosocial and consequence-related symptoms. More than 70% had multifocal hyperhidrosis. BTX-A and/or BTX-B were given to 323 children, 193 of whom received repeated treatments. The highest score in a 5-grade scale concerning treatment effect was reported by 176/193 children, i.e. their "sweating disappeared completely". No severe adverse events occurred. Focal and multifocal hyperhidrosis in children reduces quality of life considerably. Treatment with BTX-A and/or BTX-B has been performed with success.

[Hyperhidrosis is a silent handicap]. / Hyperhidrose er et tavst handicap.

Hyperhidrosis affects 2.8% of the population and has severe negative influence on life quality. The disease is represented in many specialties but can unfortunately be incorrectly treated or not treated at all. Primary hyperhidrosis is the most common form. Secondary hyperhidrosis is most often excluded by a few anamnestic data. Botulinum toxin and anticholinergics are adequate treatment options when aluminium chloride is insufficient. This article describes the disease from the physician's as well as the patient's perspective. Furthermore, examination procedures and treatment procedures are presented.

Treatment of compensatory hyperhidrosis after sympathectomy with botulinum toxin and anticholinergics.

PURPOSE: Compensatory hyperhidrosis (CH) is the most common adverse complication of sympathectomy. It often has a major negative impact on life quality. No efficient treatment of CH is available. We report nine cases of CH after sympathectomy, which were treated with botulinum toxin A/B (BTX) and anticholinergics. METHODS: The patients responded to a dermatology life quality index (DLQI) questionnaire before injections with BTX and 3 weeks after treatment. At the follow-up visit, the participants also ranked the effect of the treatment on a five-grade scale. Three patients had residual sweating after BTX treatment, and received additional anticholinergics at the follow-up visit. Those subjects eventually had a third evaluation with the DLQI. RESULTS: The DLQI score was, on average, 16.4 before treatment and decreased to 4.8 after BTX injections. Eight out of nine patients were satisfied with the treatment. The average DLQI score decreased to 2.2 when the patients with residual sweating (n = 3) received additional anticholinergics. Adverse events from BTX were mild and temporary, but dry mouth was substantial in one patient using anticholinergics. CONCLUSIONS: A combination of BTX A/B and anticholinergics alleviated the hyperhidrosis with minor side-effects. We consider this treatment safe, effective, and well tolerated.

Effect of botulinum toxin concentration on reduction in sweating: a randomized, double-blind study.

Dose-response studies of botulinum toxin for reduction of sweating are sparse in the literature. The aim of this study was to determine the most appropriate concentrations of Botox®, Dysport®, Xeomin® and NeuroBloc®, respectively, in order to achieve the greatest reduction in sweating, thus reducing the costs and increasing the safety of treatment. Four concentrations of each product were investigated. Intradermal injections of all products and concentrations were applied to the backs of 20 consenting subjects, in a randomized, double-blind manner. Areas of anhidrotic and hypohidrotic skin were measured with an iodine-starch test after 4, 8 and 12 weeks, respectively. Optimal concentrations were found to be 25 U/ml for Botox and Xeomin, approximately 100 U/ml for Dysport, and 50 U/ml for NeuroBloc. When comparing the mean anhidrotic area per unit for 100 U/ml of each product, the calculated dose conversion ratios were 1:1.6:1.2:1.3 (Botox:Dysport:Xeomin:NeuroBloc). If, instead, the optimal concentration for each product was compared, the dose conversion ratios were 1:4.8:1.3:2.2. Thus, it is crucial to consider botulinum toxin concentration in a treatment regimen.

Botulinum toxin type A and B improve quality of life in patients with axillary and palmar hyperhidrosis.

Hyperhidrosis is a common disorder that may have a severe impact on quality of life. The aim of this study was to investigate the clinical effect of two novel botulinum toxins, Xeomin®, a type A botulinum toxin, and Neuro-bloc®, a type B botulinum toxin, in the treatment of axillary and palmar hyperhidrosis. A total of 84 patients, 58 with axillary and 26 with palmar hyperhidrosis, were included in this open study. Axillae were injected with 107 ± 22 U Xeomin® and palms were injected with 213 ± 19 U Xeomin® and 264 ± 60 U Neurobloc® over the thenar eminences to avoid muscle weakness. At follow-up 3 weeks post-treatment, all patients treated for axillary hyperhidrosis reported satisfaction in self-ranking, evaporation decreased > 40%, and Dermatology Life Quality Index (DLQI) score improved from 12.0 to 1.7 (p < 0.05). In the palmar group 95% were satisfied, evaporation decreased > 50% and DLQI score improved from 10.3 to 1.2 (p < 0.05). Only one patient in the palmar group experienced muscle weakness. In conclusion, Xeomin® has an excellent effect on axillary hyperhidrosis and in combination with Neurobloc® on palmar hyperhidrosis. Neurobloc® may be an option for use in the treatment of palmar hyperhidrosis in order to minimize muscular side-effects.

Bilateral forearm intravenous regional anesthesia with prilocaine for botulinum toxin treatment of palmar hyperhidrosis.

BACKGROUND: Treatment of palmar hyperhidrosis with botulinum toxin (BTX) requires effective anesthesia, but previous methods have not provided enough pain relief or have resulted in a prolonged impaired hand function. OBJECTIVE: This is a study of bilateral forearm intravenous regional anesthesia using prilocaine for BTX treatment of palmar hyperhidrosis. METHODS: In all, 166 patients (100 female and 66 male) were treated bilaterally with intracutaneous BTX type A injections using intravenous regional anesthesia with prilocaine (5 mg/mL). In a subgroup of patients, forearm nerves were studied with neurophysiologic methods and blood concentrations of prilocaine were measured. Pain evaluation with a visual analog scale was accompanied with a questionnaire about the treatment. RESULTS: In all, 95% of the patients answering the questionnaire (response rate 89%) were satisfied with the anesthetic effect. No serious adverse events occurred. There was a fast recovery of motor function (in median 6 minutes) and sensory function (in median 20 minutes). No subclinical signs of sensory nerve damage were found. LIMITATIONS: Recall and reporting bias are potential sources of limitations in this study. CONCLUSION: Bilateral forearm intravenous regional anesthesia provides an effective and well-tolerated anesthesia during BTX treatment of palmar hyperhidrosis.

Equipotent concentrations of Botox and Dysport in the treatment of palmar hyperhidrosis.

There are indications that the dilution of botulinum toxin affects dose-response. This must be considered when comparing different products. The aim of this study was to estimate a concentration of Dysport in physiological saline that is approximately equivalent to Botox 100 U/ml with respect to anhidrotic and muscular effect. Thirty-six patients with primary palmar hyperhidrosis were treated with multiple intradermal injections of 0.02 ml botulinum toxin. Botox(R) was injected in one hand and Dysport in the other in a random order. The concentrations of Dysport were 200 U/ml (n=18), 150 U/ml (n=11) and 100 U/ml (n=7). Muscular effect was measured as the reduction in compound muscle action potential in 3 muscles in the hand and anhidrotic effect was indicated by an iodine-starch test 4 weeks after treatment. Dysport at 200 U/ml was more potent than Botox at 100 U/ml with regard to both anhidrotic and muscular effect. The equipotent concentration of Dysport, compared with Botox 100 U/ml, was found to be in the range 100-150 U/ml.

Anhidrotic effect of intradermal injections of botulinum toxin: a comparison of different products and concentrations.

Botulinum toxin is used in various fields of medicine, including in the treatment of hyperhidrosis. Three products containing botulinum toxin are commercially available in Sweden; Botox, Dysport and Neurobloc. In the literature dose-response has varied with respect to these 3 products. We hypothesized that the dilution level of botulinum toxin is of importance for the effect and we therefore investigated anhidrosis after intradermal injections of each product in 3 different concentrations. Nine healthy subjects received 0.1 ml injections in the back. The anhidrotic areas were identified by an iodine-starch test after 3 weeks. When the 3 products were diluted to 100 U/ml level the achieved mean anhidrotic areas were approximately the same. This is in strong contrast with the large dose conversion factors suggested for intramuscular injections of the products. Furthermore, the lowest used concentrations for Botox(R) (25 U/ml) and Neurobloc (100 U/ml) led to the largest anhidrotic mean area per unit, respectively. The optimal concentration in this study was 25 U/ml for Botox, 100 U/ml for Dysport and 100 U/ml for Neurobloc, but for Botox and Neurobloc the optimal concentrations may be even lower.

Treatment of pachyonychia congenita.

There are currently no specific treatments for pachyonychia congenita (PC). Available treatments generally are directed at specific manifestations of the disorder, and an effective treatment plan must recognize that different patients are more or less troubled by different manifestations of the disease. Treatment for all aspects of PC has been less than completely satisfactory. Very few studies have compared different approaches to treatment, and fewer still have given longitudinal follow-up of efficacy and patient acceptance. This review is essentially a compilation of anecdotes. It was collected from physicians' reports in the literature, from direct communication with physicians currently following patients with PC and from patients who answered a questionnaire on the Pachyonychia Congenita Project web page (http://www.pachyonychia.org/Registry.html).

Sweat gland morphology and periglandular innervation in essential palmar hyperhidrosis before and after treatment with intradermal botulinum toxin.

BACKGROUND: Intradermal botulinum toxin (Btx) produces long-lasting relief of focal hyperhidrosis, but its mechanism of action is poorly understood. OBJECTIVE: To study the effect of Btx A on the size and innervation of sweat glands in patients with palmar hyperhidrosis. METHODS: Palmar skin biopsy was performed in 26 hyperhidrotic patients before scheduled Btx treatment and in 11 controls. Twelve of the patients also underwent biopsy 1 to 6 months after the Btx injections. Sweat gland morphology was investigated by light microscopy; the cross-sectional area of the secretory tubule and its lumen was measured by image analysis. Immunofluorescence (IF) with antibodies to the neural markers protein gene product 9.5 (PGP 9.5) and growth-associated protein 43 (GAP 43), and to vasoactive intestinal peptide (VIP) and calcitonin gene-related peptide (CGRP), was used to analyze the periglandular innervation. RESULTS: The gross morphology of the sweat glands was similar in patients and controls, with no significant differences in tubular and luminal areas between the groups. After Btx treatment, the tubular dimensions remained unchanged, but the lumen tended to be smaller ( P = .07). Around the glands, increased GAP 43 staining indicating sprouting was seen within 3 months after Btx treatment ( P = .016); whereas the PGP 9.5 staining was decreased in most specimens ( P = .09) indicating lack of functional nerve growth. No change in VIP or CGRP immunoreactivity was observed. CONCLUSIONS: The sweat glands appear structurally normal in hyperhidrotic patients before Btx therapy, whereas after therapy the luminal area of the gland is frequently diminished. The IF data GAP 43/PGP 9.5 suggest that Btx therapy induces long-standing functional denervation of the sweat glands, which might explain its anti-transpiratory efficacy.

Treatment of dyshidrotic hand dermatitis with intradermal botulinum toxin.

BACKGROUND: Botulinum toxin (Btx A) has recently been used in the treatment of focal hyperhidrosis. Hyperhidrosis is also an aggravating factor in nearly 40% of patients with dyshidrotic hand eczema. OBJECTIVE: The objective of this study was to evaluate the effect of intradermal injections of Btx A on dermatitis in patients with vesicular hand dermatitis. METHODS: Ten patients with vesicular dermatitis were treated on one hand with intradermal Btx A (mean, 162 U BOTOX, Allergan Pharmaceuticals, Irvine, Calif) with the untreated side as a control. RESULTS: Self-assessment at follow-up 5 to 6 weeks after injection on a 5-point scale (none, slight, moderate, good, or very good effect) showed that 7 of 10 patients experienced good or very good effect. A decrease in itching was shown with a visual linear analogue scale (VAS) for itching, with mean 39% on the treated side compared with an increase by 52% on the untreated side. These findings were supported by the evaluation of clinical signs. Six of 7 patients who experienced good or very good effect also had aggravating hand sweating or worsening during the summer. CONCLUSION: Btx A can be a valuable alternative for patients with treatment-refractory hand eczema of the vesicular type, especially with hyperhidrosis or worsening during the summer.