Evidence map›Paper›PMID 25047038›Full record

Trial reportPloS one2014

A randomised trial evaluating the effects of the TRPV1 antagonist SB705498 on pruritus induced by histamine, and cowhage challenge in healthy volunteers.

Rachel A Gibson, Jon Robertson, Harshna Mistry, Stewart McCallum, Disala Fernando, Melody Wyres, Gil Yosipovitch

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01673529 (A Two Part Randomized, Double-blind, Placebo Controlled Study to Investigate the Effects of Topical Doses of SB705498 Oncapsaicin, Histamine, and Cowhage Responses in Healthy Volunteers.), which is not on this map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
8.0field-weighted citation impact, top 2% 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.

NCT01673529 phase1completednot on this map

A Two Part Randomized, Double-blind, Placebo Controlled Study to Investigate the Effects of Topical Doses of SB705498 Oncapsaicin, Histamine, and Cowhage Responses in Healthy Volunteers.

TypeinterventionalSponsorGlaxoSmithKlineRan2012 to 2012Enrolled16ConditionsDermatitis, AtopicArmsSB705498, Placebo
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 74 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. TRPV1: The key bridge in neuroimmune interactions.Journal of intensive medicine · 2024
    Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Observational
  19. Review
  20. Cutaneous vessel features of sensitive skin and its underlying functions.Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2020
    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

7 authors at 4 institutions in 2 countries.

Rachel A GibsonAcademic Discovery Performance Unit, GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom.
Jon RobertsonQuantitative Sciences, GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom.
Harshna MistryClinical Pharmacology Science and Study Operations GlaxoSmithKline, Cambridge, Cambridgeshire, United Kingdom.
Stewart McCallumAcademic Discovery Performance Unit, GlaxoSmithKline, Collegeville, Pennsylvania, United States of America.
Disala FernandoClinical Unit, GlaxoSmithKline, Cambridge, Cambridgeshire, United Kingdom.
Melody WyresClinical Development, Stiefel, a GSK company, Research Triangle Park, North Carolina, United States of America.
Gil YosipovitchDepartment of Dermatology and Temple Itch Center, Temple University School of Medicine, Philadelphia, Pennsylvania, United States of America.
GlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (United States) · USResearch Triangle Park Foundation · USTemple University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTransient receptor potential vanilloid type 1 (TRPV1) is a non-selective cation channel widely expressed in skin tissues, and peripheral sensory nerve fibres. Activation of TRPV1 releases neuropeptides; the resulting neurogenic inflammation is believed to contribute to the development of pruritus. A TRPV1 antagonist has the potential to perform as an anti-pruritic agent. SB705498 is a TRPV1 antagonist that has demonstrated in vitro activity against cloned TRPV1 human receptors and when orally administered has demonstrated pharmacodynamic activity in animal models and clinical studies.

objectivesTo select a topical dose of SB705498 using the TRPV1 agonist capsaicin; to confirm engagement of the TRPV1 antagonistic action of SB705498 and assess whether the dose selected has an effect on itch induced by two challenge agents.

methodsA clinical study was conducted in 16 healthy volunteers to assess the effects of 3 doses of SB705498 on skin flare induced by capsaicin. Subjects with a robust capsaicin response were chosen to determine if the selected topical formulation of SB705498 had an effect on challenge agent induced itch.

resultsFollowing capsaicin challenge the greatest average reduction in area of flare was seen for the 3% formulation. This dose was selected for further investigation. Itch intensity induced by two challenge agents (cowhage and histamine) was assessed on the Computerised Visual Analogue Scale. The difference in average itch intensity (Weighted Mean Over 15 Mins) between the 3% dose of SB705498 and placebo for the cowhage challenge was -0.64, whilst the histamine challenge showed on average a -4.65 point change.

conclusionsThe 3% topical formulation of SB705498 cream was clinically well tolerated and had target specific pharmacodynamic activity. However there were no clinically significant differences on pruritus induced by either challenge agent in comparison to placebo. SB705498 is unlikely to be of symptomatic benefit for histaminergic or non-histaminergic induced itch.

trial registrationClinicalTrials.gov NCT01673529.

Indexed as

Administration, TopicalAdultCapsaicinHealthy VolunteersHistamineHumansMaleMiddle AgedPruritusPyrrolidinesSkinTRPV Cation ChannelsUreaCapsaicinHistaminePyrrolidinesSB 705498TRPV1 receptorTRPV Cation ChannelsUrea

Identifiers

PMID25047038
PMCPMC4105653
OpenAlexW2000953416

What OpenQuestion holds

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LicenceCC BY
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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.