Evidence map›Paper›PMID 21876641›Full record

Trial reportInfectious diseases in obstetrics and gynecology2011

Imiquimod 3.75% cream applied daily to treat anogenital warts: combined results from women in two randomized, placebo-controlled studies.

David A Baker, Daron G Ferris, Mark G Martens, Kenneth H Fife, Stephen K Tyring, Libby Edwards, Anita Nelson, Kevin Ault, Kenneth F Trofatter, Tiepu Liu and 2 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Infectious diseases in obstetrics and gynecology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03901690 (Betaglucin 0.2% Gel Versus Imiquimod Cream 5% in the Treatment of Anogenital Warts in 102 Individuals Older Than 18 Years.), which is not on this map. Cited by 13 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 4 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.

NCT03901690 phase3unknown statusnot on this mapstarted 2019, after this paper: background citation

Betaglucin 0.2% Gel Versus Imiquimod Cream 5% in the Treatment of Anogenital Warts in 102 Individuals Older Than 18 Years.

TypeinterventionalSponsorCentro de Investigaciones Medicas y Ensayos Clinicos Dr Italo FabbriRan2019 to 2020Enrolled102ConditionsGenital Wart Virus InfectionArmsBetaglucin soluble gel 0.2%, Imiquimod 5% cream
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Guideline
  2. Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021
    Guideline
  3. Sexually transmitted diseases treatment guidelines, 2015.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2015
    Guideline
  4. Imiquimod for anogenital warts in non-immunocompromised adults.The Cochrane database of systematic reviews · 2014
    Pooled it
  5. [Anogenital warts-An update].Dermatologie (Heidelberg, Germany) · 2024
    Review
  6. Current and future direction in treatment of HPV-related cervical disease.Journal of molecular medicine (Berlin, Germany) · 2022
    Review
  7. Article
  8. Article
  9. Position statement for the diagnosis and management of anogenital warts.Journal of the European Academy of Dermatology and Venereology : JEADV · 2019
    Article
  10. Approved Antiviral Drugs over the Past 50 Years.Clinical microbiology reviews · 2016
    Review
  11. Review
  12. Review
  13. Clinical and pathological aspects of condyloma acuminatum - review of literature and case presentation.Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie
    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

12 authors.

David A BakerDivision of Infectious Disease, Department of Obstetrics, Gynecology & Reproductive Medicine, Stony Brook Health Science Center, Stony Brook University Medical Center, Stony Brook, NY 11794-8091, USA. dbaker@notes.cc.sunysb.edu
Daron G Ferris
Mark G Martens
Kenneth H Fife
Stephen K Tyring
Libby Edwards
Anita Nelson
Kevin Ault
Kenneth F Trofatter
Tiepu Liu
Sharon Levy
Jason Wu

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate if new imiquimod formulations using a shorter treatment duration are safe and efficacious to treat anogenital warts.

methodsIn two studies 534 women ≥12 years of age (mean 33.4) with 2-30 warts (mean 7.9) and total wart area ≥10 mm(2) (mean 166.3) were randomized (1:2:2) to placebo (106), imiquimod 2.5% (212) or 3.75% (216) creams applied once daily until complete clearance or a maximum of 8 weeks.

resultsFor placebo, imiquimod 2.5% and 3.75%, respectively, complete clearance of all warts was achieved in 14.2%, 28.3%, and 36.6% of women (intent-to-treat, P = 0.008 imiquimod 2.5%, and P < 0.001 3.75% versus placebo). Mean changes in wart counts were -10.7%, -50.9%, and -63.5% (per-protocol, P < 0.001 each active versus placebo) and safety-related discontinuation rates 0.9%, 1.4%, and 2.3%.

conclusionsImiquimod 3.75% applied daily for up to 8 weeks was well tolerated and superior to placebo in treating women with external anogenital warts.

Indexed as

AdolescentAdultAgedAged, 80 and overAminoquinolinesAntiviral AgentsCondylomata AcuminataData Interpretation, StatisticalFemaleGenital Diseases, FemaleHumansImiquimodMiddle AgedPlacebosTreatment OutcomeAminoquinolinesAntiviral AgentsImiquimodPlacebos

Identifiers

PMID21876641
PMCPMC3162968

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.