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OpenTrials
Completed

NCT Number: NCT01398280

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of California, San Diego Perlman Ambulatory Center

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical aminocaproic acid (ACA) mixed with Vanicream

Drug

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

Vehicle cream

Drug

Vehicle cream moisturizer twice daily for up to 12 weeks

Primary outcomes

  1. Kallikrein 5 (KLK5) Protease Activity

    Time frame: Up to 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study 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.

Acronym: ACA

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2011
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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