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

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ClinicalTrials.gov Identifier: NCT02806414
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Galderma
Information provided by (Responsible Party):
Tissa Hata, MD, University of California, San Diego

Brief Summary:
This study will assess the role of topical Ivermectin 1% cream and its effect on protease and antimicrobial peptide expression 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 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. At the end of the study, tape strips will be analyzed to determine serine protease activity 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 over time, and they will also determine whether or not these changes correlate with disease severity.

Condition or disease Intervention/treatment Phase
Rosacea Drug: Ivermectin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : July 2016
Actual Primary Completion Date : July 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Ivermectin
All subjects will be treated with topical ivermectin daily for up to 12 weeks.
Drug: Ivermectin
Other Name: Soolantra




Primary Outcome Measures :
  1. The change in biochemical markers of rosacea-specific inflammation, LL-37 and KLK5, after 12 weeks of topical ivermectin. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The correlation between the change in clinical rosacea assessments after 12 weeks of topical ivermectin application and the change in LL-37 and KLK5. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806414


Locations
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United States, California
UCSD Division of Dermatology
San Diego, California, United States, 92122
Sponsors and Collaborators
University of California, San Diego
Galderma
Investigators
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Principal Investigator: Tissa Hata, MD UCSD Division of Dermatology

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Responsible Party: Tissa Hata, MD, Professor of Dermatology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02806414     History of Changes
Other Study ID Numbers: UCSD 160765
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Rosacea
Inflammation
Pathologic Processes
Skin Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents