An Early Phase 1 interventional study of Topical aminocaproic acid (ACA) mixed with Vanicream and Vehicle cream in Rosacea, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-13.
Sponsored by University of California, San Diego · Early Phase 1, Interventional, and Basic science
The purpose of this study is to determine the effect of topical aminocaproic acid on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with rosacea. It is hypothesized that aminocaproic acid applied topically will alter the body's immune system in patients with rosacea by inhibiting activation of antimicrobial peptides.
225 studies on the registry are indexed under Rosacea; 19 are open to participants now.
This study's enrollment of 15 is below the median of 61 across 195 interventional studies indexed under Rosacea.
Browse Rosacea studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
Subjects will treat their facial skin twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess Kallikrein 5 (KLK5) activity.
Drug: Topical aminocaproic acid (ACA) mixed with Vanicream
Subjects will apply vehicle twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess Kallikrein 5 (KLK5) activity.
Drug: Vehicle cream
25% Aminocaproic acid cream twice daily for up to 12 weeks.
Vehicle cream moisturizer twice daily for up to 12 weeks
Kallikrein 5 (KLK5) Protease Activity
Serine protease activity of KLK5 in adult skin from patients with rosacea is measured after treatment with vehicle or aminocaproic acid cream. Protease activity of facial skin surface is monitored using a synthetic fluorogenic trypsin-like proteinase substrate. Protease activity is monitored as an increase of fluorescence (RFU/uL) with SpectraMax GEMINI EM.
Time frame: Up to 12 weeks
| Milestone | Aminocaproic Acid (ACA) | Vehicle Cream |
|---|---|---|
| Started | 11 | 4 |
| Completed | 7 | 4 |
| Not completed | 4 | 0 |
Serine protease activity of KLK5 in adult skin from patients with rosacea is measured after treatment with vehicle or aminocaproic acid cream. Protease activity of facial skin surface is monitored using a synthetic fluorogenic trypsin-like proteinase substrate. Protease activity is monitored as an increase of fluorescence (RFU/uL) with SpectraMax GEMINI EM.
| RFU/uL | Aminocaproic Acid (ACA) | Vehicle Cream |
|---|---|---|
| Kallikrein 5 (KLK5) Protease Activity | 581.1 ± 261.0 | 816.5 ± 422.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aminocaproic Acid (ACA) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Vehicle Cream | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Continuous(years) | Aminocaproic Acid (ACA) | Vehicle Cream | Total |
|---|---|---|---|
| Mean | 53 ± 18.5 | 63 ± 5.6 | 55.7 ± 16.5 |
| Sex: Female, Male(Participants) | Aminocaproic Acid (ACA) | Vehicle Cream | Total |
|---|---|---|---|
| Female | 7 | 3 | 10 |
| Male | 4 | 1 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Aminocaproic Acid (ACA) | Vehicle Cream | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 6 | 2 | 8 |
| Unknown or Not Reported | 3 | 1 | 4 |
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Diego