Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation
This study has been completed.
Sponsor:
University of California, San Diego
Information provided by (Responsible Party):
Jeremiah Miller, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01398280
First received: July 19, 2011
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rosacea |
Drug: Topical aminocaproic acid (ACA) mixed with Vanicream Drug: Vehicle cream |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Rosacea
Drug Information available for:
Aminocaproic acid
U.S. FDA Resources
Further study details as provided by University of California, San Diego:
Primary Outcome Measures:
- Cathelicidin protein analysis [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]To determine the effect of aminocaproic acid on the antimicrobial peptide cathelicidin in adult skin from patients with rosacea.
Secondary Outcome Measures:
- KLK5 protease activity [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]To determine the effect of topical aminocaproic acid on serine protrease activity of kallikrein 5 in adult skin from patients with rosacea
| Enrollment: | 15 |
| Study Start Date: | July 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 KLK activity and LL-37 expression.
|
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 KLK activity and LL-37 expression.
|
Drug: Vehicle cream
Vehicle cream moisturizer twice daily for up to 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398280
Locations
| United States, California | |
| University of California, San Diego Perlman Ambulatory Center | |
| La Jolla, California, United States, 92037 | |
Sponsors and Collaborators
University of California, San Diego
Investigators
| Principal Investigator: | Tissa Hata, MD | University of California, San Diego |
More Information
Additional Information:
Publications:
| Responsible Party: | Jeremiah Miller, Resident-Physician, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT01398280 History of Changes |
| Other Study ID Numbers: | 100867 |
| Study First Received: | July 19, 2011 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
|
Rosacea Dermatology UCSD Skin disease |
Additional relevant MeSH terms:
|
Inflammation Rosacea Pathologic Processes Skin Diseases 6-Aminocaproic Acid Antifibrinolytic Agents Fibrin Modulating Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013