Clinical trial NCT01398280: Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Rosacea
Keywords: Rosacea
Dermatology
UCSD
Skin disease
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Kallikrein 5 (KLK5) Protease Activity
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego Perlman Ambulatory Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Tissa Hata, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1038/nm1616. Epub 2007 Aug 5.
citation: Yamasaki K, Gallo RL. The molecular pathology of rosacea. J Dermatol Sci. 2009 Aug;55(2):77-81. doi: 10.1016/j.jdermsci.2009.04.007. Epub 2009 May 29.