Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation

This study has been completed.
Sponsor:
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
  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:


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
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, see Learn About Clinical Studies.

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 July 20, 2014