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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin | Experimental | All subjects will be treated with topical ivermectin daily for up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Trypsin-like Enzyme Activity | Activity was quantified using a protease activity assay involving aprotinin, a known selective inhibitor of trypsin-related enzyme activity | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Fold Change in Cathelicidin mRNA | Ratio of fold change in cathelicidin mRNA at 12 weeks to fold change in cathelicidin mRNA at baseline | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tissa Hata, MD | UCSD Division of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Division of Dermatology | San Diego | California | 92122 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ivermectin | All subjects will be treated with topical ivermectin daily for up to 12 weeks. Ivermectin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ivermectin | All subjects will be treated with topical ivermectin daily for up to 12 weeks. Ivermectin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Inter-Quartile Range | percentage of baseline | 12 weeks |
|
|
Baseline visit to follow-up phone visit (4 months total)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ivermectin | All subjects will be treated with topical ivermectin daily for up to 12 weeks. Ivermectin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| melanoma excision | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials Unit | UCSD Dermatology | 8586571697 | dermstudies@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2020 | Aug 17, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | Posted | Mean | Inter-Quartile Range | ratio | 12 weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 3 |
| 25 |
| cold | Infections and infestations | Non-systematic Assessment |
|
| mild bleeding | Investigations | Non-systematic Assessment | intermittently from tape stripping site for 2 days |
|
| ear infection | Infections and infestations | Non-systematic Assessment |
|
| epidermal inclusion cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
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