Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation (ACA)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01398280 |
Recruitment Status :
Completed
First Posted : July 20, 2011
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | Randomized |
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 |

Arm | Intervention/treatment |
---|---|
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject is male or non-pregnant female, 18 - 70 years of age.
- Subjects willing and able to give informed consent.
- Subjects willing and able to comply with the requirements of the study.
- Subject has the clinical diagnosis of at least mild/moderate papulopustular rosacea (3-20 papulopustules) and at least mild erythema.
- Subject has been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) OR the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study
- Subject is in general good health in the opinion of the investigator.
- Subject has a calculated creatinine clearance 100% of normal range.
- Subject has normal baseline labs or in the opinion of the investigator are values are not clinically significant and would not inhibit the ability to monitor the patient for both safety and efficacy throughout the study.
Exclusion Criteria:
- Subject has a diagnosis of Steroid Rosacea or Pyoderma Faciale (rosacea fulminans)
- Subject has a history of Carcinoid, Pheochromocytoma, Serotonin Syndrome or other systemic flushing causes.
- Subject has used facial topical therapies (OTC drug products or prescription products) for any reason within the prior 28 days
- Subject has used systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days.
- Subject has had laser or light-based treatment for rosacea within the prior 3 months.
- Subject has had systemic retinoids and retinoid derivatives over the past 6 months
- Subject has an active or recent history of any coagulation (hyper or hypo) disorder, genitourinary bleeding, myopathy, cardiomyopathy, rhabdomyolysis or evidence of clinically significant hepatic disease in the opinion of the investigator,
- Subject is taking any medicines or supplements that interfere with blood clotting such as Coumadin, Plavix, or ASA (>81mg/day).
- Subject has a known hypersensitivity or allergy to aminocaproic acid or components of the vehicle.
- Subject is pregnant or lactating or planning a pregnancy during the duration of the study
- Subject has been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study
- Subject has clinically significant findings, medical history or conditions (other than rosacea), which in the opinion of the Investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation.

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 |
Responsible Party: | Tissa Hata, MD, Clinical Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT01398280 |
Other Study ID Numbers: |
100867 |
First Posted: | July 20, 2011 Key Record Dates |
Results First Posted: | September 13, 2019 |
Last Update Posted: | September 13, 2019 |
Last Verified: | August 2019 |
Rosacea Dermatology UCSD Skin disease |
Rosacea Inflammation Pathologic Processes Skin Diseases Aminocaproic Acid |
Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |