Evidence map›Paper›PMID 33433785›Full record

Trial reportClinical pharmacokinetics2021

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

David M Pariser, Edward L Lain, Richard D Mamelok, Janice Drew, Diane R Mould

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02016885 phase2completednot on this map

A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

TypeinterventionalSponsorJourney Medical CorporationRan2013 to 2014Enrolled198ConditionsHyperhidrosisArmsglycopyrrolate, 1.0%, glycopyrrolate, 2.0%, glycopyrrolate, 3.0%, glycopyrrolate, 4.0%, Vehicle
NCT02129660 phase2completednot on this map

A Phase 2, Randomized, Double-Blind Vehicle-Controlled Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis

TypeinterventionalSponsorJourney Medical CorporationRan2014 to 2015Enrolled105ConditionsHyperhidrosisArmsDose 1 of glycopyrrolate, 2.0% QD, Dose 2 of glycopyrrolate, 3.0% QD, Dose 1 of glycopyrronium, 2.5% QD, Dose 2 of glycopyrronium, 3.75% QD, Vehicle
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 1 country.

David M PariserEastern Virginia Medical School and Virginia Clinical Research, Inc., 6160 Kempsville Circle, Suite 200A, Norfolk, VA, 23502, USA. dpariser@pariserderm.com.
Edward L LainAustin Institute for Clinical Research, Austin, TX, USA.
Richard D MamelokMamelok Consulting, Palo Alto, CA, USA.
Janice DrewDermira, Inc., a wholly owned subsidiary of Eli Lilly and Company, Menlo Park, CA, USA.
Diane R MouldProjections Research, Inc., Phoenixville, PA, USA.
Eastern Virginia Medical School · USEli Lilly (United States) · USHouston Institute for Clinical Research · USPhoenixville Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlycopyrronium tosylate (GT; Qbrexza

objectiveThe 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.

methodsIn 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.

resultsGlycopyrronium 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.

conclusionsThese 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).

Indexed as

GlycopyrrolateHyperhidrosisAdolescentAdultAgedAxillaChildCholinergic AntagonistsHumansMiddle AgedMuscarinic AntagonistsYoung AdultCholinergic AntagonistsGlycopyrrolateglycopyrronium tosylateMuscarinic Antagonists

Identifiers

PMID33433785
PMCPMC8113176
OpenAlexW3120772925

What OpenQuestion holds

Textmetadata
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.