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

Sponsor:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT01398280

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

Estimated Enrollment:	12
Study Start Date:	July 2011
Estimated Primary Completion Date:	July 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

Contacts

Contact: Alvin B Coda, MD	858-657-7192	ucsddermstudies@gmail.com
Contact: Maryam Afshar, MD	858-657-8390	ucsddermstudies@gmail.com

Locations

United States, California
University of California, San Diego Perlman Ambulatory Center	Recruiting
La Jolla, California, United States, 92037
Contact: Alvin B Coda, MD 858-657-7192 acoda@ucsd.edu
Contact: Maryam Afshar, MD 858-657-8390 maafshar@ucsd.edu
Sub-Investigator: Richard L Gallo, MD PhD
Principal Investigator: Tissa Hata, MD

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator:

Tissa Hata, MD

University of California, San Diego

More Information

Additional Information:

UCSD Dermatology - Clinical Trials Unit This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2007 Aug 5.

Yamasaki K, Gallo RL. The molecular pathology of rosacea. J Dermatol Sci. 2009 Aug;55(2):77-81. Epub 2009 May 29. Review.

Responsible Party:	Tissa Hata, M.D., UCSD Dermatology, Clinical Trials Unit
ClinicalTrials.gov Identifier:	NCT01398280 History of Changes
Other Study ID Numbers:	100867
Study First Received:	July 19, 2011
Last Updated:	July 19, 2011
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, 2012