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Trial · Interventional

CompletedEarly phase 1Results postedRegistry data

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

Short name ACA

This trial does not test a peptide that PepBank tracks.

  • Names LL-37, does not test it. It appears in the title.

Overview

Status
Completed
Phase
Early phase 1
Enrollment
15 participants (actual)
Sponsor
University of California, San Diego · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jul 2011
Primary completion
Dec 2012
Completion
Dec 2012
First posted
20 Jul 2011 (estimated)
Last update posted
13 Sept 2019
Conditions
Rosacea

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013
  1. Ph Early 1

    ACA

    NCT01398280

    Jul 2011 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Topical aminocaproic acid (ACA) mixed with VanicreamDrug
  • Vehicle creamDrug

Arms2

  • Experimental

    Aminocaproic Acid (ACA)

    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.

  • Placebo comparator

    Vehicle cream

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Kallikrein 5 (KLK5) Protease Activity

    Time frame · Up to 12 weeks

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Up to 12 weeks

Kallikrein 5 (KLK5) Protease Activity

GroupValue (RFU/uL)Spread
Aminocaproic Acid (ACA)581.1261.0
Vehicle Cream816.5422.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Aminocaproic Acid (ACA)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 KLK activity and LL-37 expression. Topical aminocaproic acid (ACA) mixed with Vanicream: 25% Aminocaproic acid cream twice daily for up to 12 weeks.0 / 110 / 110 / 11
Vehicle CreamSubjects 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 KLK activity and LL-37 expression. Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks0 / 40 / 40 / 4

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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