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

Information source: University of California, San Diego
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rosacea

Intervention: Topical aminocaproic acid (ACA) mixed with Vanicream (Drug); Vehicle cream (Drug)

Phase: Phase 0

Status: Recruiting

Sponsored by: University of California, San Diego

Official(s) and/or principal investigator(s):
Tissa Hata, MD, Principal Investigator, Affiliation: University of California, San Diego

Overall contact:
Alvin B Coda, MD, Phone: 858-657-7192, Email: ucsddermstudies@gmail.com

Summary

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Cathelicidin protein analysis

Secondary outcome: KLK5 protease activity

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Alvin B Coda, MD, Phone: 858-657-7192, Email: ucsddermstudies@gmail.com

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

UCSD Dermatology - Clinical Trials Unit

Related 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.

Starting date: July 2011
Last updated: July 19, 2011

Page last updated: December 08, 2011

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