Skip to main content
OpenTrials
Completed

NCT Number: NCT02806414

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UCSD Division of Dermatology

San Diego, California, 92122, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivermectin

Drug

Other names: Soolantra

Primary outcomes

  1. Relative Trypsin-like Enzyme Activity

    Time frame: 12 weeks

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

Secondary outcomes

  1. Relative Fold Change in Cathelicidin mRNA

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Galderma R&D

Registry information

Official study title

A Single Site Evaluation of the Inhibitory Effects of Topical Ivermectin on Serine Protease Activity and Production of LL-37 Cathelicidin Peptide, Biochemical Markers of Rosacea-specific Inflammation and on the Skin Microbiome in Rosacea.

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Jun 20, 2016
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.