Evidence map›Paper›PMID 30378087›Full record

Trial reportAmerican journal of clinical dermatology2019

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.

David M Pariser, Adelaide A Hebert, Janice Drew, John Quiring, Ramanan Gopalan, Dee Anna Glaser

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of clinical dermatology, 2019. 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 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT02530281 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhydrosis

TypeinterventionalSponsorJourney Medical CorporationRan2015 to 2016Enrolled344ConditionsHyperhidrosisArmsglycopyrronium Topical Wipes, Vehicle
NCT02530294 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis

TypeinterventionalSponsorJourney Medical CorporationRan2015 to 2016Enrolled353ConditionsHyperhidrosisArmsglycopyrronium Topical Wipes, Vehicle
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Quality of life in individuals with primary hyperhidrosis: a systematic review and meta-analysis.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2023
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Observational
  15. Article
  16. Treatment of Hyperhidrosis: An Update.American journal of clinical dermatology · 2022
    Review
  17. Realizing the Potential of the Patient Perspective.Patient preference and adherence · 2020
    Article
  18. Review
  19. Management Strategies Of Palmar Hyperhidrosis: Challenges And Solutions.Clinical, cosmetic and investigational dermatology · 2019
    Article
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

6 authors.

David M PariserEastern Virginia Medical School and Virginia Clinical Research, Inc., 6160 Kempsville Circle, Suite 200A, Norfolk, VA, 23502, USA. dpariser@pariserderm.com.
Adelaide A HebertUTHealth McGovern Medical School, Houston, TX, USA.
Janice DrewDermira, Inc., Menlo Park, CA, USA.
John QuiringQST Consultations, Allendale, MI, USA.
Ramanan GopalanDermira, Inc., Menlo Park, CA, USA.
Dee Anna GlaserSaint Louis University, St. Louis, MO, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlycopyrronium 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.

objectiveOur objective was to evaluate patient-reported outcomes (PROs) from these trials.

methodsPatients 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.

resultsIn 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.

conclusionsPRO results demonstrated that GT reduced the disease burden of primary axillary hyperhidrosis.

trial registrationClinicaltrials.gov; ATMOS-1 (NCT02530281), ATMOS-2 (NCT02530294).

Indexed as

Patient Reported Outcome MeasuresAdolescentAdultAxillaChildCholinergic AntagonistsDouble-Blind MethodFemaleGlycopyrrolateHumansHyperhidrosisMaleMiddle AgedQuality of LifeSeverity of Illness IndexSweatingCholinergic AntagonistsGlycopyrrolateglycopyrronium tosylate

Identifiers

PMID30378087
PMCPMC6516143

What OpenQuestion holds

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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.