Rosacea
Conditions
Brief summary
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
DRUGIvermectin
Sponsors
Galderma R&D
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Trypsin-like Enzyme Activity | 12 weeks | Activity was quantified using a protease activity assay involving aprotinin, a known selective inhibitor of trypsin-related enzyme activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Fold Change in Cathelicidin mRNA | 12 weeks | Ratio of fold change in cathelicidin mRNA at 12 weeks to fold change in cathelicidin mRNA at baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ivermectin All subjects will be treated with topical ivermectin daily for up to 12 weeks.
Ivermectin | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Ivermectin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 58.3 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 3 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Relative Trypsin-like Enzyme Activity
Activity was quantified using a protease activity assay involving aprotinin, a known selective inhibitor of trypsin-related enzyme activity
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ivermectin | Relative Trypsin-like Enzyme Activity | 1.10 percentage of baseline |
Secondary
Relative Fold Change in Cathelicidin mRNA
Ratio of fold change in cathelicidin mRNA at 12 weeks to fold change in cathelicidin mRNA at baseline
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ivermectin | Relative Fold Change in Cathelicidin mRNA | 3.25 ratio |