RosaceaEarly Phase 1ACANCT01398280
Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation
A Early Phase 1 study testing Topical aminocaproic acid (ACA) mixed with Vanicream in people with Rosacea, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rosacea
- What is being tested?
- Topical aminocaproic acid (ACA) mixed with Vanicream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2012
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego Perlman Ambulatory Center
La Jolla, California, 92037
About this study
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.
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
- Being tested
- Topical aminocaproic acid (ACA) mixed with Vanicream, Vehicle cream
- Keywords
- Rosacea, Dermatology, UCSD, Skin disease
- Medical subject headings
- Rosacea, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical aminocaproic acid (ACA) mixed with VanicreamDrug
25% Aminocaproic acid cream twice daily for up to 12 weeks.
Vehicle creamDrug
Vehicle cream moisturizer twice daily for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tissa Hata, MD, University of California, San Diego
- Investigators
- Tissa Hata, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398280
- Sponsor's protocol ID
- 100867
- Acronym
- ACA
- Status last verified
- Aug 2019
- First submitted
- 19 Jul 2011
- Last updated
- 13 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 17676051Yamasaki 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01398280
- Acronym / sponsor ID
- ACA / 100867
- Conditions
- Rosacea
- Keywords
- Rosacea, Dermatology, UCSD, Skin disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Posted 13 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aminocaproic Acid (ACA) | Experimental | Drug: Topical aminocaproic acid (ACA) mixed with VanicreamSubjects 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. |
| Vehicle cream | Placebo comparator | Drug: 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 Kallikrein 5 (KLK5) activity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical aminocaproic acid (ACA) mixed with Vanicream25% Aminocaproic acid cream twice daily for up to 12 weeks. | Drug | Aminocaproic Acid (ACA) |
| Vehicle creamVehicle cream moisturizer twice daily for up to 12 weeks | Drug | Vehicle cream |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17676051Yamasaki 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.
- Background: PubMed 19481425Yamasaki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tissa Hata, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Topical aminocaproic acid (ACA) mixed with Vanicream in people with Rosacea, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kallikrein 5 (KLK5) Protease Activity (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01398280, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.