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

NCT01398280 | Completed Early Phase 1 Results

• 1 other identifier: 100867
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea

Keywords

Rosacea; Dermatology; UCSD; Skin disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Aminocaproic Acid (ACA)

EXPERIMENTAL

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 Kallikrein 5 (KLK5) activity.

Drug: Topical aminocaproic acid (ACA) mixed with Vanicream

Vehicle cream

PLACEBO COMPARATOR

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 Kallikrein 5 (KLK5) activity.

Drug: Vehicle cream

Interventions

Topical aminocaproic acid (ACA) mixed with Vanicream DRUG

25% Aminocaproic acid cream twice daily for up to 12 weeks.

Aminocaproic Acid (ACA)

Vehicle cream DRUG

Vehicle cream moisturizer twice daily for up to 12 weeks

Vehicle cream

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego Perlman Ambulatory Center

La Jolla, California, 92037, United States

Location

Related 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. doi: 10.1038/nm1616. Epub 2007 Aug 5.

  PMID: 17676051 BACKGROUND

• 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.

  PMID: 19481425 BACKGROUND

MeSH Terms

Conditions

Rosacea; Skin Diseases

Interventions

Aminocaproic Acid; Antibodies, Anticardiolipin

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminocaproates; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Antibodies, Antiphospholipid; Autoantibodies; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCSD Dermatology Clinical Trials Manager
• Organization: UCSD Dermatology Clinical Trials

dermstudies@ucsd.edu

(858)657-8390

Study Officials

• Tissa Hata, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 20, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 13, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-08

Locations

US (1)