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CompletedNCT01398280ACAUpdated Sep 13, 2019Results posted

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

An Early Phase 1 interventional study of Topical aminocaproic acid (ACA) mixed with Vanicream and Vehicle cream in Rosacea, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-13.

Sponsored by University of California, San Diego · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

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Conditions studied

  • Rosacea

Keywords

  • Rosacea
  • Dermatology
  • UCSD
  • Skin disease
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In context

Rosacea

225 studies on the registry are indexed under Rosacea; 19 are open to participants now.

This study's enrollment of 15 is below the median of 61 across 195 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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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Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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.

    Drug: Topical aminocaproic acid (ACA) mixed with Vanicream

  • 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.

    Drug: Vehicle cream

Interventions

  • DrugTopical aminocaproic acid (ACA) mixed with Vanicream

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

  • DrugVehicle cream

    Vehicle cream moisturizer twice daily for up to 12 weeks

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What researchers measure

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.

    Time frame: Up to 12 weeks

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Results

Posted Sep 13, 2019

Participant flow

Participant flow — Overall Study
MilestoneAminocaproic Acid (ACA)Vehicle Cream
Started114
Completed74
Not completed40

Outcome measures

PrimaryKallikrein 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.

Time frame:
Up to 12 weeks
Reported as:
Mean · RFU/uL
Kallikrein 5 (KLK5) Protease Activity
RFU/uLAminocaproic Acid (ACA)Vehicle Cream
Kallikrein 5 (KLK5) Protease Activity581.1 ± 261.0816.5 ± 422.4

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Aminocaproic Acid (ACA)0/11 (0%)0/11 (0%)0/11 (0%)
Vehicle Cream0/4 (0%)0/4 (0%)0/4 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Aminocaproic Acid (ACA)Vehicle CreamTotal
Mean53 ± 18.563 ± 5.655.7 ± 16.5
Sex: Female, Male
Sex: Female, Male(Participants)Aminocaproic Acid (ACA)Vehicle CreamTotal
Female7310
Male415
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Aminocaproic Acid (ACA)Vehicle CreamTotal
Hispanic or Latino213
Not Hispanic or Latino628
Unknown or Not Reported314
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Study locations

1 site
  • University of California, San Diego Perlman Ambulatory Center
    La Jolla, California 92037, United States
09

References and documents

Publications

  • 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. PubMed 17676051 ↗
  • 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. PubMed 19481425 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01398280
Lead sponsor
University of California, San Diego
Responsible party
Tissa Hata, MD (Clinical Professor, University of California, San Diego) — Principal investigator
First posted
Jul 20, 2011
Start date
Jul 2011
Primary completion
Dec 2012
Completion
Dec 2012
Results posted
Sep 13, 2019
Last update
Sep 13, 2019

Study contacts

Tissa Hata, MD
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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