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

Rosacea Clinical Trial

— ACA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398280
• Other study ID #: 100867
• Status: Completed
• Phase: Early Phase 1
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Rosacea

Intervention

Drug:
• Topical aminocaproic acid (ACA) mixed with Vanicream
25% Aminocaproic acid cream twice daily for up to 12 weeks.
• Vehicle cream
Vehicle cream moisturizer twice daily for up to 12 weeks

Locations

Country	Name	City	State
United States	University of California, San Diego Perlman Ambulatory Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kallikrein 5 (KLK5) Protease Activity	Serine protease activity of KLK5 in adult skin from patients with rosacea is measured after treatment with vehicle or aminocaproic acid cream. Protease activity of facial skin surface is monitored using a synthetic fluorogenic trypsin-like proteinase substrate. Protease activity is monitored as an increase of fluorescence (RFU/uL) with SpectraMax GEMINI EM.	Up to 12 weeks