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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aminocaproic Acid (ACA) | Experimental | 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. |
|
| Vehicle cream | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical aminocaproic acid (ACA) mixed with Vanicream | Drug | 25% Aminocaproic acid cream twice daily for up to 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tissa Hata, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego Perlman Ambulatory Center | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17676051 | Background | Yamasaki K, Di Nardo A, Bardan A, Murakami M, Ohtake T, Coda A, Dorschner RA, Bonnart C, Descargues P, Hovnanian A, Morhenn VB, Gallo RL. Increased serine protease activity and cathelicidin promotes skin inflammation in rosacea. Nat Med. 2007 Aug;13(8):975-80. doi: 10.1038/nm1616. Epub 2007 Aug 5. | |
| 19481425 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 KLK activity and LL-37 expression. Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Posted | Mean | Standard Deviation | RFU/uL | Up to 12 weeks |
|
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCSD Dermatology Clinical Trials Manager | UCSD Dermatology Clinical Trials | (858)657-8390 | dermstudies@ucsd.edu |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015119 | Aminocaproic Acid |
| D017153 | Antibodies, Anticardiolipin |
| ID | Term |
|---|---|
| D000614 | Aminocaproates |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Vehicle cream | Drug | Vehicle cream moisturizer twice daily for up to 12 weeks |
|
| Yamasaki K, Gallo RL. The molecular pathology of rosacea. J Dermatol Sci. 2009 Aug;55(2):77-81. doi: 10.1016/j.jdermsci.2009.04.007. Epub 2009 May 29. |
| BG001 | 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 KLK activity and LL-37 expression. Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| 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 KLK activity and LL-37 expression. Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | 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 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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| D009930 |
| Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017152 | Antibodies, Antiphospholipid |
| D001323 | Autoantibodies |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |