Evaluation of the Inhibitory Effects of Topical Ivermectin on Markers of Rosacea Specific Inflammation.
| Status: | Recruiting |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 8/24/2018 |
| Start Date: | July 2016 |
| End Date: | August 2019 |
| Contact: | Faiza Shafiq |
| Email: | ucsddermstudies@ucsd.edu |
| Phone: | 858-657-8390 |
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.
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.
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.
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
We found this trial at
1
site
San Diego, California 92122
Principal Investigator: Tissa Hata, MD
Phone: 858-657-7192
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