Kallikrein 5 (KLK5) Protease Activity
| Group | Value (RFU/uL) | Spread |
|---|---|---|
| Aminocaproic Acid (ACA) | 581.1 | 261.0 |
| Vehicle Cream | 816.5 | 422.4 |
Trial · Interventional
CompletedEarly phase 1Results postedRegistry dataShort name ACA
This trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Aminocaproic Acid (ACA)
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.
Placebo comparator
Vehicle cream
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.
Outcomes the sponsor listed as primary.
Kallikrein 5 (KLK5) Protease Activity
Time frame · Up to 12 weeks
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (RFU/uL) | Spread |
|---|---|---|
| Aminocaproic Acid (ACA) | 581.1 | 261.0 |
| Vehicle Cream | 816.5 | 422.4 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Aminocaproic Acid (ACA)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 KLK activity and LL-37 expression. Topical aminocaproic acid (ACA) mixed with Vanicream: 25% Aminocaproic acid cream twice daily for up to 12 weeks. | 0 / 11 | 0 / 11 | 0 / 11 |
| Vehicle CreamSubjects 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 KLK activity and LL-37 expression. Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks | 0 / 4 | 0 / 4 | 0 / 4 |
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