Evidence map›Paper›PMID 31755993›Full record

Trial reportBritish journal of clinical pharmacology2020

Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus-induced genital lesions.

Melanie Rijsbergen, Rianne Rijneveld, Marina Todd, Gary L Feiss, Stijn T P Kouwenhoven, Koen D Quint, Dirk C J G van Alewijk, Maurits N C de Koning, Erica S Klaassen, Jacobus Burggraaf and 2 more

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
0.8field-weighted citation impact, top 26% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
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  3. Emerging antimicrobial peptides in gastrointestinal disorders: Dual role in immunity and therapy.World journal of gastrointestinal pharmacology and therapeutics · 2026
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  6. Advances of Antimicrobial Peptides in the Treatment of Multidrug-Resistant Bacteria.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
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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 at 5 institutions in 2 countries.

Melanie RijsbergenCentre for Human Drug Research, Leiden, the Netherlands.ORCID 0000-0001-8609-9635
Rianne RijneveldCentre for Human Drug Research, Leiden, the Netherlands.
Marina ToddCentre for Human Drug Research, Leiden, the Netherlands.
Gary L FeissCutanea Life Sciences, Wayne, Pennsylvania, USA.
Stijn T P KouwenhovenDepartment of Dermatology, Leiden University Medical Centre, Leiden, the Netherlands.
Koen D QuintDepartment of Dermatology, Leiden University Medical Centre, Leiden, the Netherlands.
Dirk C J G van AlewijkDDL Diagnostic Laboratory, Rijswijk, the Netherlands.
Maurits N C de KoningDDL Diagnostic Laboratory, Rijswijk, the Netherlands.
Erica S KlaassenCentre for Human Drug Research, Leiden, the Netherlands.
Jacobus BurggraafCentre for Human Drug Research, Leiden, the Netherlands.
Robert RissmannCentre for Human Drug Research, Leiden, the Netherlands.ORCID 0000-0002-5867-9090
Mariëtte I E van PoelgeestCentre for Human Drug Research, Leiden, the Netherlands.
Centre for Human Drug Research · NLLeiden University Medical Center · NLDDL Diagnostic Laboratory · NLLeiden University · NLWayne County Regional Educational Service Agency · US

Funding

Cutanea Life Sciences
6 · The paper itself

Abstract

aimsTo assess safety and tolerability and explore pharmacodynamics and efficacy of omiganan in external anogenital warts (AGW) and vulvar high-grade squamous intraepithelial lesions (HSIL).

methodsTwo randomized controlled trials in patients with external AGW and vulvar HSIL were conducted. Patients received topical omiganan 2.5% or placebo gel once daily for 12 weeks with a follow-up of 12 weeks. Safety and tolerability were monitored and pharmacodynamics and clinical efficacy of omiganan were assessed by analysing lesion count, size and viral load. Self-reported pain, itch and quality of life were assessed by an electronic diary and questionnaire.

resultsTwenty-four AGW and 12 vulvar HSIL patients were enrolled. All patients had a high treatment adherence (99%). No serious adverse events occurred and all adverse events (n = 27) were mild, transient and self-limiting. The treatment groups were not different in terms of safety and tolerability, lesion count and size, and patient-reported outcomes pain, itch and quality of life. Human papillomavirus load significantly reduced after 12 weeks of treatment with omiganan compared to placebo (-96.6%; 95% confidence interval -99.9 to -7.4%; P = .045) in AGW patients only.

conclusionTopical omiganan appears to be safe in patients with AGW and vulvar HSIL and reduced human papillomavirus load after 12 weeks of treatment in AGW patients.

Indexed as

AlphapapillomavirusPapillomavirus InfectionsAntimicrobial Cationic PeptidesGenitaliaHumansPapillomaviridaeQuality of LifeAntimicrobial Cationic PeptidesOmiganandermatologymedication safetypharmacodynamicspharmacokineticsvirology

Identifiers

PMID31755993
PMCPMC7576619
OpenAlexW2989616181

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.