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Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials.

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Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials.

Pediatr Dermatol. 2018 Nov 19;:

Authors: Hebert AA, Glaser DA, Green L, Werschler WP, Forsha DW, Drew J, Gopalan R, Pariser DM

Abstract
OBJECTIVES: Hyperhidrosis in pediatric patients has been understudied. Post hoc analyses of two phase 3 randomized, vehicle-controlled, 4-week trials (ATMOS-1 [NCT02530281] and ATMOS-2 [NCT02530294]) were performed to assess efficacy and safety of topical anticholinergic glycopyrronium tosylate (GT) in pediatric patients.
METHODS: Patients had primary axillary hyperhidrosis ≥ 6 months, average Axillary Sweating Daily Diary (ASDD/ASDD-Children [ASDD-C]) Item 2 (sweating severity) score ≥ 4, sweat production ≥ 50 mg/5 min (each axilla), and Hyperhidrosis Disease Severity Scale (HDSS) ≥ 3. Coprimary end points were ≥ 4-point improvement on ASDD/ASDD-C Item 2 (a validated patient-reported outcome) and change in gravimetrically measured sweat production at Week 4. Efficacy and safety data are shown through Week 4 for the pediatric (≥ 9 to ≤ 16 years) vs older (> 16 years) subgroups.
RESULTS: Six hundred and ninety-seven patients were randomized in ATMOS-1/ATMOS-2 (GT, N = 463; vehicle, N = 234); 44 were ≥ 9 to ≤ 16 years (GT, n = 25; vehicle, n = 19). Baseline disease characteristics were generally similar across subgroups. GT-treated pediatric vs older patients had comparable improvements in ASDD/ASDD-C Item 2 (sweating severity) responder rate, HDSS responder rate (≥ 2-grade improvement]), sweat production, and quality of life (mean change from Baseline in Dermatology Life Quality Index [DLQI]/children’s DLQI), with greater improvement vs vehicle. Treatment-emergent adverse events were similar between subgroups, and most were mild, transient, and infrequently led to discontinuation.
CONCLUSIONS: Topical, once-daily GT improved disease severity (ASDD/ASDD-C, HDSS), sweat production, and quality of life (DLQI), with similar findings in children, adults, and the pooled population. GT was well tolerated, and treatment-emergent adverse events were qualitatively similar between subgroups and consistent with other anticholinergics.

PMID: 30451318 [PubMed – as supplied by publisher]

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Comparative study of transepidermal water loss in patients with and without hyperhidrosis by closed-chamber measurer in an air-conditioned environment.

Comparative study of transepidermal water loss in patients with and without hyperhidrosis by closed-chamber measurer in an air-conditioned environment.

Einstein (Sao Paulo). 2018 Nov 08;16(4):eAO4312

Authors: Miotto A, Honda PAA, Bachichi TG, Holanda CS, Evangelista Neto E, Perfeito JAJ, Leão LEV, Costa ADS

Abstract
OBJECTIVE: To evaluate the difference in transepidermal water loss in patients diagnosed with hyperhidrosis and healthy subjects, in an air-conditioned environment.
METHODS: Twenty patients diagnosed with hyperhidrosis and 20 healthy subjects were subjected to quantitative assessment using a closed-chamber device, in six previously established sites.
RESULTS: The measurements showed different transepidermal water loss values for healthy subjects and patients with hyperhidrosis, especially in the hands and feet. In the Control Group, the median for the hands was 46.4g/m2/hour (p25: 36.0; p75: 57.6), while in the Hyperhidrosis Group, the median was 123.5g/m2/hour (p25: 54.3; p75: 161.2) – p<0.001. For the feet, the Control Group had a median of 41.5g/m2/hour (p25: 31.3; p75: 63.5) and the Hyperhidrosis Group, 61.2g/m2/hour (p25: 32.3; p75: 117) - p<0.02. Measurements of the axillas also showed differences. In the Control Group, the median was 14.8g/m2/hour (p25: 11.8; p75: 19.0) and, in the Hyperhidrosis Group, 83.5g/m2/hour (p25: 29.5; p75: 161.7) - p<0.001.
CONCLUSION: Measuring transepidermal water loss is sufficient for diagnosis and follow-up of patients with hyperhidrosis.

PMID: 30427484 [PubMed – in process]

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Changes in Palm Temperature as Predictor of Long-term Cure of Sympathicotomy for Palmar hyperhidrosis?

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Changes in Palm Temperature as Predictor of Long-term Cure of Sympathicotomy for Palmar hyperhidrosis?

J Neurol Surg A Cent Eur Neurosurg. 2018 Oct 31;:

Authors: Liu G, Kang G, Huang J, Xie S, Hu H

Abstract
OBJECTIVES:  To investigate the long-term relationship between intraoperative temperature changes of the palm, treatment effects and compensatory hyperhidrosis (CH).
METHODS:  We retrospectively analyzed the data of 41 patients with palmar hyperhidrosis who underwent bilateral endoscopic sympathicotomy 3 to 6 years ago. Before and after the operation, changes in ipsilateral palm temperature were monitored and recorded to evaluate the curative effect of the sympathicotomy.
RESULTS:  All operations were performed successfully. Concerning cure, there was no statistically significant difference between patients with different maximum temperature (Tmax) values (p = 0.455). There was a very weak correlation between postoperative palm temperature (34.309 ± 1.377°C) (p = 0.049; correlation coefficient - 0.218). The T3 + T4 sympathicotomies had a higher Tmax (p = 0.000). The incidence and degree of CH had no relationship with Tmax in the left (p = 0.266 and p = 0.168, respectively) or the right hand (p = 0.640 and p = 0.824, respectively).
CONCLUSIONS:  Temperature change has a relationship with surgery, but it cannot directly predict the long-term curative effect of a sympathicotomy or the occurrence of CH. Additional studies are required.

PMID: 30381813 [PubMed – as supplied by publisher]

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Topical Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Patient-Reported Outcomes from the ATMOS-1 and ATMOS-2 Phase III Randomized Controlled Trials.

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Topical Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Patient-Reported Outcomes from the ATMOS-1 and ATMOS-2 Phase III Randomized Controlled Trials.

Am J Clin Dermatol. 2018 Oct 30;:

Authors: Pariser DM, Hebert AA, Drew J, Quiring J, Gopalan R, Glaser DA

Abstract
BACKGROUND: Glycopyrronium tosylate (GT) is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years. GT was evaluated for primary axillary hyperhidrosis in replicate, randomized, double-blind, vehicle-controlled, phase III trials. GT reduced sweating severity and production versus vehicle and was generally well tolerated.
OBJECTIVE: Our objective was to evaluate patient-reported outcomes (PROs) from these trials.
METHODS: Patients aged ≥ 9 years with primary axillary hyperhidrosis ≥ 6 months, gravimetrically measured sweat production ≥ 50 mg/5 min in each axilla, Axillary Sweating Daily Diary (ASDD) Item 2 severity score ≥ 4, and Hyperhidrosis Disease Severity Scale (HDSS) score ≥ 3 were randomized 2:1 to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks. The 4-item ASDD, 6 Weekly Impact (WI) items, Patient Global Impression of Change (PGIC), HDSS, and Dermatology Life Quality Index (DLQI) were utilized.
RESULTS: In the pooled population, 463 patients were randomized to GT and 234 to vehicle; 426 (92.0%) and 225 (96.2%) completed the trials. At baseline, most patients considered their axillary sweating to be at least moderate in severity, impact, and bothersomeness (ASDD items 2, 3, and 4, respectively). Improvement was substantially greater for GT than for vehicle at every study week, and, at week 4, ASDD scores improved from baseline by 62.6 versus 34.0% (severity), 65.5 versus 40.3% (impact), and 65.4 versus 39.0% (bothersomeness). Improvements favoring GT versus vehicle also occurred for WI items, PGIC, HDSS, and DLQI.
CONCLUSIONS: PRO results demonstrated that GT reduced the disease burden of primary axillary hyperhidrosis.
TRIAL REGISTRATION: Clinicaltrials.gov; ATMOS-1 (NCT02530281), ATMOS-2 (NCT02530294).

PMID: 30378087 [PubMed – as supplied by publisher]

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Genetic polymorphism analysis of patients with primary hyperhidrosis.

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Genetic polymorphism analysis of patients with primary hyperhidrosis.

Clin Cosmet Investig Dermatol. 2018;11:477-483

Authors: Simes BC, Moore JP, Brown TC, Rushforth TJ, Bookout AL, Richardson CL

Abstract
Background: Hyperhidrosis affects 220 million people worldwide. The hallmark of this condition is excessive sweating, which negatively impacts the social, emotional, and occupational lives of these individuals. A familial predisposition has been established; however, the specific genes involved have yet to be identified.
Objective: The aim of this study was to determine possible genetic variations contributing to primary hyperhidrosis, specifically single-nucleotide polymorphisms (SNPs).
Patients and methods: Twenty-one case and 21 control DNA samples were extracted and genotyped for 20 SNPs associated with the Butyrylcholinesterase (BCHE) and Cholinergic Receptor Nicotinic Alpha-7 subunit (CHRNA7) genes.
Results: For rs1126680, the -116A variant allele (P-value=0.15) was found only in hyperhidrosis patients who also had the K-variant allele (P-value=0.65) in rs1803274. Further analysis testing the null hypothesis of independence between the combined genotypes and case/control status yielded a P-value of 0.30.
Conclusion: Our results are consistent with previous research that shows the K-variant requires the -116A variant to be present in order to observe a decrease in BChE activity levels. These results are not statistically significant (P-value >0.05), but the exclusive association between the -116A and K-variants on the BCHE gene in hyperhidrosis patients warrants further investigation using a larger sample size.

PMID: 30349345 [PubMed]

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Clinical evaluation of an antiperspirant for hyperhidrosis.

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Clinical evaluation of an antiperspirant for hyperhidrosis.

G Ital Dermatol Venereol. 2018 Sep 20;:

Authors: Bussoletti C, Mastropietro F, Tolaini MV, Celleno L, Pigatto PD

Abstract
BACKGROUND: Hyperhidrosis is a fairly common condition characterized by excessive sweating, usually in axillary areas. Although not involving major health problems, it is a significant psychological distress to those affected, compromising their social life. The first line of defense used to address this problem are antiperspirants, usually containing aluminum salts, capable of blocking the excessive sweating.
METHODS: We made a clinical trial to test the deodorant effectiveness and anti-bacterial activity of an antiperspirant product, based on Agaricine, Aluminum hydrochloride and Silver Citrate, in a panel of 20 subjects following a single laboratory application under controlled conditions. Later, the same product has been tested for skin compatibility, effectiveness and cosmetic quality after repeated home applications under normal conditions of use for 14 consecutive days.
RESULTS: After 6 and 24 hours from the application, the microbial load observed in treated axilla was inferior in a statistically significant way compared to the untreated axilla. There was not found the presence of pathogenic bacteria on any of the two armpits. The tested product has shown an excellent anti-bacterial activity.
CONCLUSIONS: Overall, the product has been highly appreciated by the volunteers for its effectiveness and its cosmetic qualities, particularly because it has a good deodorant activity, its deodorant activities persist throughout the day, it does not stain clothes, and it has a practical package.

PMID: 30249082 [PubMed – as supplied by publisher]