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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

Evaluation of the Inhibitory Effects of Topical Ivermectin on Markers of Rosacea Specific Inflammation.

NCTNCT02806414 (opens ClinicalTrials.gov in a new tab)Other idUCSD 160765
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names LL-37, does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
25 participants (actual)
Sponsor
University of California, San Diego · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jul 2016
Primary completion
Jul 2019
Completion
May 2021
First posted
20 Jun 2016 (estimated)
Last update posted
5 Oct 2021
Conditions
Rosacea

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019202020212022
  1. Ph 1/2

    Evaluation of the Inhibitory Effects of Topical Ivermectin on Markers of Rosacea Specific Inflammation.

    NCT02806414

    Jul 2016 to May 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will assess the role of topical Ivermectin 1% cream and its effect on protease and antimicrobial peptide expression and on the skin microbiome (the microorganisms that live on the skin) in rosacea. This is a single-site 16-week open-label study at University of California, San Diego. The investigators will do this by first measuring serine protease activity and cathelicidin and skin microbiome of all subjects. All subjects will receive Ivermectin topical cream and will be instructed on how to apply it daily for 12 weeks. Participants will return for monthly visits during which their clinical symptoms of facial redness and number of facial papules will be scored, and they will have repeat tape stripping and/or skin swabs. At the end of the study, tape strips and skin swabs will be analyzed to determine serine protease activity and skin microbiome of participants at each of their visits and expression of cathelicidin (LL-37) mRNA. The investigators will then look at changes in serine protease activity and LL-37 expression and skin microbiome over time, and they will also determine whether or not these changes correlate with disease severity.

Interventions

  • IvermectinDrug

Arms1

  • Experimental

    Ivermectin

    All subjects will be treated with topical ivermectin daily for up to 12 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Relative Trypsin-like Enzyme Activity

    Time frame · 12 weeks

    Registry description

    Activity was quantified using a protease activity assay involving aprotinin, a known selective inhibitor of trypsin-related enzyme activity

Secondary outcomes(1)

  1. Relative Fold Change in Cathelicidin mRNA

    Time frame · 12 weeks

    Registry description

    Ratio of fold change in cathelicidin mRNA at 12 weeks to fold change in cathelicidin mRNA at baseline

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12 weeks

Relative Trypsin-like Enzyme Activity

GroupValue (percentage of baseline)
Ivermectin1.10
Secondary and other outcome results(1)
Secondary outcomeMean· 12 weeks

Relative Fold Change in Cathelicidin mRNA

GroupValue (ratio)
Ivermectin3.25

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
IvermectinAll subjects will be treated with topical ivermectin daily for up to 12 weeks. Ivermectin0 / 250 / 253 / 25

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subject is male or non-pregnant female, 18 - 70 years of age. * Subjects willing and able to give informed consent. * Subjects willing and able to comply with the requirements of the study. * Subject has the clinical diagnosis of rosacea with at least one inflammatory papule and at least mild erythema. * Subject has been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) OR the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study * Subject is in general good health in the opinion of the investigator. * Subject has normal baseline labs or in the opinion of the investigator are values are not clinically significant and would not inhibit the ability to monitor the patient for both safety and efficacy throughout the study. Exclusion Criteria: * Subject has a diagnosis of Steroid Rosacea or Pyoderma Faciale (rosacea fulminans). * Subject has used facial topical therapies (OTC drug products or prescription products) for any reason within the prior 28 days * Subject has used systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days. * Subject has had laser or light-based treatment for rosacea within the prior 3 months. * Subject has had systemic retinoids and retinoid derivatives over the past 6 months * Subject has a known hypersensitivity or allergy to topical ivermectin or components of the vehicle. * Subject is pregnant or lactating or planning a pregnancy during the duration of the study * Subject has been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study * Subject has clinically significant findings, medical history or conditions (other than rosacea), which in the opinion of the Investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation

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