Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation (ACA)
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|ClinicalTrials.gov Identifier: NCT01398280|
Recruitment Status : Completed
First Posted : July 20, 2011
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rosacea||Drug: Topical aminocaproic acid (ACA) mixed with Vanicream Drug: Vehicle cream||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Single Site Evaluation of the Effect of Topical Application of Aminocaproic Acid (ACA) to Inhibit Kallikrein 5 Serine Protease Activity and Production of LL-37 Cathelicidin Peptide, Biochemical Markers of Rosacea-specific Inflammation.|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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.
Drug: Topical aminocaproic acid (ACA) mixed with Vanicream
25% Aminocaproic acid cream twice daily for up to 12 weeks.
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.
Drug: Vehicle cream
Vehicle cream moisturizer twice daily for up to 12 weeks
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398280
|United States, California|
|University of California, San Diego Perlman Ambulatory Center|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Tissa Hata, MD||University of California, San Diego|