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A Phase 2a Trial Investigating the Safety and Tolerability of the Novel Cortical Enhancer IRL752 in Parkinson’s Disease Dementia

Abstract

Background
IRL752 is a novel small‐molecule compound that acts to regioselectively enhance norepinephrine, dopamine, and acetylcholine neurotransmission in the cerebral cortex.

Objective
The primary objective of the trial was to investigate the safety and tolerability of IRL752 in patients with Parkinson’s disease and dementia.

Methods
Patients with Parkinson’s disease and dementia were randomized to IRL752 or placebo treatment (3:1 ratio) for 28 days. The study drug was given as an adjunct treatment to the patients’ regular stable antiparkinsonian medication. Dosing was individually titrated for 14 days after which the dose was kept stable for an additional 14 days.

Results
A total of 32 patients were randomized to treatment, and 29 patients completed the 4‐week treatment. Adverse events were generally mild and transient and were mostly reported during the dose titration phase. There were 2 serious adverse events, and none of them were related to the experimental treatment. The average dose achieved in the stable dose phase was 600 mg daily, yielding a 2‐hour postdose plasma concentration of about 4 μM on day 28. Exploratory assessment of secondary outcomes indicated efficacy for symptoms and signs known to be poorly responsive to levodopa.

Conclusions
IRL752 appears to be safe and well tolerated for a 4‐week treatment in patients with Parkinson’s disease and dementia. © 2020 International Parkinson and Movement Disorder Society

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Successful treatment of Pityriasis Versicolor by photodynamic therapy mediated by methylene blue

Abstract

Background
Although systemic therapies are recommended for severe or recalcitrant cases of pityriasis versicolor (PV), they are not free of important side effects and drug interactions. Photodynamic therapy (PDT) utilizes the action of singlet oxygen and free radicals produced by a light‐activated photosensitizer to kill viruses, bacteria, or fungi. In this study, the effect of a PDT mediated by methylene blue (MB) in PV was evaluated.

Methods
Five women with PV disseminated on the back and diagnosed by fresh microscopic analysis were treated with a solution of MB (2%) applied to the PV lesions for 3 minutes. Next, a red LED lamp (λ = 630±5 nm, 37 J/cm2), placed 100 mm from the skin for 10 minutes, was applied on the dyed PV lesions. Six sessions of MB/PDT were implemented with a 2‐week interval in between. Wood’s lamp examination was used to monitor fungal infection at each time point.

Results
Complete cure was observed in the five women at the 4 weeks post‐treatment follow‐up. Fluoresce images from PV lesions by Wood’s lamp allowed to evaluate whether the lesions were healed or not at each time point. No patient showed relapse at the 6‐month follow‐up. The patients did not have any adverse effect, and good cosmetic outcome was observed.

Conclusions
Six sessions of MB/PDT spaced at 14‐day intervals are sufficient for the treatment for PV in healthy patients.

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Quality of life after thoracic sympathectomy for palmar hyperhidrosis: a meta-analysis.

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Quality of life after thoracic sympathectomy for palmar hyperhidrosis: a meta-analysis.

Gen Thorac Cardiovasc Surg. 2020 May 10;:

Authors: Wei Y, Xu ZD, Li H

Abstract
OBJECTIVE: Palmar hyperhidrosis affects 0.6-10% of the general population, having an important impact in patients’ quality of life. The definitive treatment for palmar hyperhidrosis is thoracic sympathectomy. The purpose of this study is to evaluate the quality of life after thoracic sympathectomy for palmar hyperhidrosis.
METHODS: The interest studies were searched in six comprehensive databases. The quality of the studies was assessed using the risk of bias tool recommended by the Cochrane system evaluation manual. Meta-analysis was performed with RevMan version 5.3. The outcome of interest was quality of life. The subgroup analysis and sensitive analysis were performed.
RESULTS: Nine trials, including 895 patients, with accessible data comparing preoperative quality of life score with postoperative quality-of-life score were used for data analysis. Compared with preoperative quality-of-life score, application of thoracic sympathectomy improved the postoperative quality of life of palmar hyperhidrosis patients (MD = 57.81, 95% CI 53.33-62.30). Subgroup analysis of the different thoracic sympathectomy segment showed that there was no significant difference in the results obtained when operated with single segment or multiple segments (single segment: MD = 61.16, 95% CI [56.10, 66.22], multiple segments: MD = 52.14, 95% CI [48.39, 55.88]).
CONCLUSION: The meta-analysis provided evidence of the improved quality of life after thoracic sympathectomy for palmar hyperhidrosis.

PMID: 32390086 [PubMed – as supplied by publisher]

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The impact of endoscopic thoracic sympathectomy on sudomotor function in patients with palmar hyperhidrosis.

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The impact of endoscopic thoracic sympathectomy on sudomotor function in patients with palmar hyperhidrosis.

Clin Auton Res. 2020 Apr 27;:

Authors: Hirakawa N, Higashimoto I, Takamaori A, Tsukamoto E, Uemura Y

Abstract
PURPOSE: When performing endoscopic thoracic sympathectomy (ETS) in palmar hyperhidrosis patients, a device can be used to measure sweat volume pre- and postoperatively in order to assess indications and treatment effects. In this study, we measured changes in the dynamics of sweating in hyperhidrosis patients pre- and postoperatively and compared the values with those in healthy subjects without hyperhidrosis.
METHODS: The patient group comprised 25 persons with palmar hyperhidrosis who were scheduled for ETS. The dynamics of sweating was measured at 1 day prior to surgery and at 2 days postoperatively, in 18 patients at > 1 year postoperatively in another palmar hyperhidrosis group, and in 20 healthy subjects without hyperhidrosis. A device for measuring local sweat volume was applied at the thenar eminence of both palms. Indicators established were basal sweat rate (BSR; mg/min/cm2), peak sweat rate (PSR; mg/min/cm2) during mental stress (sympathetic sweating response), sweat volume (SV), and sweat time (ST; s).
RESULTS: After surgery, all of the indicators were significantly reduced in hyperhidrosis patients and there was very little response to mental stress. The subgroup of these patients assessed at > 1 year after ETS showed a trend of increased BSR similar to that of healthy subjects. These changes did not correlate with the extent of the removal surgery. Preoperatively, hyperhidrosis patients had significantly greater BSR, PSR, and SV and longer ST than healthy subjects.
CONCLUSION: All of the sweating parameters were increased in palmar hyperhidrosis patients prior to surgery. Immediately after ETS, all these parameters were significantly reduced. At > 1 year after ETS, the BSR had increased to a level similar to that of the healthy volunteers, although PSR did not respond to mental stress.

PMID: 32342237 [PubMed – as supplied by publisher]

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Correlation between benign joint hypermobility syndrome and primary focal hyperhidrosis in children: a novel concept.

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Correlation between benign joint hypermobility syndrome and primary focal hyperhidrosis in children: a novel concept.

BMC Musculoskelet Disord. 2020 Apr 24;21(1):268

Authors: Parvaneh VJ, Shahvaladi H, Rahmani K, Yekta SJ, Gorji FA, Shiari R, Abdollahimajd F

Abstract
BACKGROUND: Benign joint hypermobility syndrome (BJHS) is one of the most common hereditary connective tissue disorders in children in which autonomic nervous system involvement has been reported. This study aimed to evaluate the frequency of primary focal hyperhidrosis in children with BJHS.
METHODS: This observational-analytical study was conducted in a case-control setting on children aged 3 to 15 years in 2018 at Mofid Children’s Hospital, Tehran, Iran. Benign joint hypermobility syndrome was diagnosed according to the Brighton criteria; then, the patients referred to a dermatologist for evaluation of hyperhidrosis.
RESULTS: In total, 130 eligible patients with confirmed BJHS and 160 age- and sex-matched healthy subjects were enrolled in this study. Primary focal hyperhidrosis (PFH) was seen in 56.2 and 16.3% of the cases and controls, respectively, indicating a significant difference (P < 0.05). The severity of hyperhidrosis did not differ between the two groups.
CONCLUSION: Although the results of the study showed a significant correlation between BJHS and PFH, more comprehensive studies are needed to confirm these findings.

PMID: 32331513 [PubMed – as supplied by publisher]

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Long-term results of the treatment of primary hyperhidrosis with oxybutynin: follow-up of 1,658 cases.

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Long-term results of the treatment of primary hyperhidrosis with oxybutynin: follow-up of 1,658 cases.

Int J Dermatol. 2020 Apr 16;:

Authors: Wolosker N, Kauffman P, de Campos JRM, Faustino CB, da Silva MFA, Teivelis MP, Puech-Leão P

Abstract
BACKGROUND: Hyperhidrosis (HH) is characterized by exaggerated sweating in a specific region due to hyperfunction of the sweat glands. In the late 2000s, we started treating patients with an anticholinergic, oxybutynin, that was not being used until then.
OBJECTIVES: To present, after 12 years of utilizing this medication in our service, the substantial experience obtained with the use of oxybutynin as an initial treatment of HH in a large series of 1,658 patients.
METHODS: We analyzed 1,658 patients treated with oxybutynin for HH from May 2006 to June 2018. The patients were divided into four groups according to the main site of HH: the plantar group, the axillary group, the facial group, and the palmar group. To measure the degree of satisfaction, a quality of life (QoL) questionnaire was used.
RESULTS: Pre-treatment QoL was poor or very poor in more than 94% of the cases, and the palmar group had the worst quality of life. After treatment, we observed an improvement in the quality of life in 77% of patients. More than 70% of the patients in all groups present moderate or optimal subjective clinical improvement in sweating after treatment. The group with the best result was the facial group. Intense dry mouth was reported in 24.9% of all patients in all groups.
CONCLUSIONS: This study included a large number of patients followed for a long period and demonstrated the good effectiveness of treatment with oxybutynin for hyperhidrosis in the main sites of sweating.

PMID: 32301117 [PubMed – as supplied by publisher]

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New sympathicotomy for prevention of severe compensatory hyperhidrosis in patients with primary hyperhidrosis.

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New sympathicotomy for prevention of severe compensatory hyperhidrosis in patients with primary hyperhidrosis.

J Thorac Dis. 2020 Mar;12(3):765-772

Authors: Han JW, Kim JJ, Kim YH, Kim IS, Jeong SC

Abstract
Background: Primary hyperhidrosis (PH) is characterized by excessive and uncontrollable secretion in the eccrine sweat glands of the craniofacial region, armpits, hands, and feet. Sympathicotomy is the most effective treatment for severe PH; however, compensatory hyperhidrosis (CH) remains the most devastating postoperative complication. The purpose of the present study was to suggest a new sympathicotomy method for PH to prevent severe CH.
Methods: From March 2014 to December 2018, a total of 212 patients were included in the study. R2 (53 cases) sympathicotomy for craniofacial hyperhidrosis and R3 (79 cases) or R4 (80 cases) sympathicotomy for palmar hyperhidrosis using the thoracoscopic technique were performed, respectively. Sympathicotomy was performed using two different methods (conventional 145 cases and new 67 cases). Expanded sympathicotomy was performed as the new method (67 cases), which was divided into two groups (partial- and full-expanded sympathicotomy). Operative effectiveness was evaluated by a reduction in percentage of post-operative sweating compared with pre-operative sweating and groups were divided into complete and incomplete sweat reduction characteristics. Complete sweat reduction was defined as sweat reduction ≥80% compared with preoperative sweating. The degrees of CH were classified as negligible, mild bothering (tolerable), and severe bothering (intolerable). Data on preoperative subject characteristics, disease status, operative technique, and postoperative outcomes were gathered using medical records and telephone surveys.
Results: According to sympathicotomy techniques, the conventional procedure (non-expanded sympathicotomy) was performed in 145 cases and the new expanded sympathicotomy procedure was performed in 67 cases (partial-expanded sympathicotomy 28 cases; full-expanded sympathicotomy 39 cases). Craniofacial hyperhidrosis was significantly more prevalent in the older group and in female patients (P<0.001 and P=0.007, respectively). Sympathicotomy was significantly more effective in palmar hyperhidrosis than craniofacial hyperhidrosis (P<0.001). CH was significantly more severe in craniofacial hyperhidrosis than palmar hyperhidrosis after sympathicotomy (P<0.001). In craniofacial hyperhidrosis, there was no significant difference in sweat reduction and CH between conventional and the expanded sympathicotomy techniques (P=0.177 and P=0.474, respectively). In palmar hyperhidrosis, there was no significant difference in sweat reduction between the conventional and the expanded sympathicotomy (P=0.178), however, degree of CH in the conventional technique was significantly more severe than in the expanded technique (P=0.001). Regarding comparison between partial- and full-expanded sympathicotomy, there was no significant difference in sweat reduction between partial-, and full-expanded sympathicotomy; however, CH was significantly more severe in partial-expanded sympathicotomy (craniofacial hyperhidrosis P=0.006; palmar hyperhidrosis P<0.001). Irrespective of hyperhidrosis types, there was no significant difference in sweat reduction between full-expanded and the others (non-expanded and partial-expanded sympathicotomy), however, full-expanded sympathicotomy showed a significantly less degree of CH than non-expanded and partial-expanded sympathicotomy (craniofacial, P=0.002; palmar, P<0.001).
Conclusions: Full-expanded sympathicotomy is a safe and feasible treatment that shows a significant decrease in the degree of CH with the same effect in sweat reduction in both craniofacial and palmar hyperhidrosis. Importantly, no severe CH developed after a full-expanded sympathicotomy without any major postoperative complications.

PMID: 32274143 [PubMed]

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Robotic Staged Bilateral Selective Postganglionic Sympathectomy for Upper-Extremity Hyperhidrosis.

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Robotic Staged Bilateral Selective Postganglionic Sympathectomy for Upper-Extremity Hyperhidrosis.

Surg Technol Int. 2020 Apr 06;36:

Authors: Gharagozloo F, Meyer M, Tempesta B

Abstract
PURPOSE: The prevalence of compensatory hyperhidrosis (CH) has been reported to be as high as 80% in patients following thoracic sympathectomy for upper-extremity hyperhidrosis. The CH rate is 7.2% with simultaneous bilateral robotic selective dorsal sympathectomy. We reviewed the results in patients who underwent staged bilateral robotic selective dorsal sympathectomy (SBRSS).
METHODS: A case series analysis of patients who underwent SBRSS was performed. A surgical robot was used to divide the postganglionic sympathetic fibers and communicating rami to intercostal nerves 2, 3, and 4. The sympathetic chain was left intact. The operation was performed on the dominant side, and the same procedure was then performed on the contralateral side after 4 weeks. The success of the sympathectomy was determined by intraoperative temperature measurement, patient interviews, and the Hyperhidrosis Disease Severity Scale.
RESULTS: There were 47 patients (22 men, 25 women), with a mean age of 22 ± 3 years. Minor complications were seen in 4% of patients. One patient had transient heart block. One patient had transient partial Horner’s syndrome. Forty percent of patients had transient CH after the first surgery, and 45% had transient CH after sympathectomy on the contralateral side. There were no deaths. The median hospitalization was 3 days. At a mean follow-up of 28 ± 6 months, 46/47 patients (98%) had sustained relief of hyperhidrosis. In one patient (1/47, 2%), hyperhidrosis recurred on the first operated side. One patient (2%) exhibited sustained CH.
CONCLUSION: SBRSS is associated with a lower rate of CH than when the procedure is performed bilaterally in a simultaneous fashion. This procedure is associated with the lowest reported rate of CH.

PMID: 32250442 [PubMed – as supplied by publisher]

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Microwave Thermolysis Reduces Generalized and Social Anxiety in Young Adults With Axillary Hyperhidrosis.

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Microwave Thermolysis Reduces Generalized and Social Anxiety in Young Adults With Axillary Hyperhidrosis.

Lasers Surg Med. 2020 Mar 16;:

Authors: Parrish C, Waldbaum B, Coleman D, Blevins C, Rodgers K, Lee B, Ober C, Hudhud L, Cox S, Griffin C, Chew S, Chen B, Brock M

Abstract
BACKGROUND AND OBJECTIVE: Hyperhidrosis (HH) is associated with impairments in quality of life (QOL) and elevated anxiety. Microwave thermolysis is a newer treatment that reduces sweating, yet effects on QOL and emotional symptoms have not been examined. Two treatment sessions are recommended to achieve 80% amelioration of clinical HH. We hypothesized that microwave thermolysis would reduce sweat severity, improve QOL, and reduce anxiety in young adults suffering from axillary HH in a prospective clinical trial.
STUDY DESIGN/MATERIALS AND METHODS: We enrolled 24 young adults (mean age = 23.57 years, 54% female) with elevated scores on the Hyperhidrosis Disease Severity Scale. All participants received one session of microwave thermolysis, and 83% received two sessions. Participants completed measures of sweat severity, QOL, generalized anxiety, social anxiety, social avoidance, and anxious/depressive mood symptoms at baseline; post-first treatment; and following second treatment.
RESULTS: At baseline, all participants had severe sweating; 87.5% had impaired QOL, 75% had elevated social anxiety, 50% with generalized anxiety, 48% with social avoidance, and 38% with anxious/depressed mood. Paired samples t tests indicated significant improvements from baseline to first procedure, including decreased sweating (t(21) = 5.68, P < 0.001), improved QOL (t(23) = 4.97, P < 0.001), and decreased generalized anxiety (t(23) = 8.11, P < 0.001), social anxiety (t(22) = 4.55, P < 0.001), mood symptoms (t(21) = 3.81, P = 0.001), and social avoidance (t(22) = 3.12, P = 0.005). After second treatment, further improvements were noted in sweating (t(18) = 3.28, P = 0.004) and QOL (t(18) = 3.83, P = 0.003), and a marginal trend for generalized anxiety (t(19) = 1.96, P = 0.064).
CONCLUSION: There were significant improvements in sweat severity, skin-specific QOL, generalized anxiety, social anxiety, anxious/depressive symptoms, and social avoidance. The majority of the psychosocial benefit appears to emerge after one treatment of microwave thermolysis, whereas the level of sweat severity and QOL continued to show further improvements after a second treatment. Results would suggest that although two microwave thermolysis sessions are needed for maximal treatment optimization of axillary HH, patients may experience significant benefits in improving psychosocial functioning after just one session. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.

PMID: 32175622 [PubMed – as supplied by publisher]