Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01398280
Other study ID # 100867
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date July 2011
Est. completion date December 2012

Study information

Verified date August 2019
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Topical aminocaproic acid (ACA) mixed with Vanicream
25% Aminocaproic acid cream twice daily for up to 12 weeks.
Vehicle cream
Vehicle cream moisturizer twice daily for up to 12 weeks

Locations

Country Name City State
United States University of California, San Diego Perlman Ambulatory Center La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & 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. Epub 2007 Aug 5. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT05597462 - Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks Phase 1
Completed NCT02601963 - Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea Phase 2
Completed NCT02249065 - Mirvaso in Use Study Phase 4
Completed NCT02292797 - Assessment of the Rosacea Prevalence in the General Population N/A
Completed NCT01659853 - Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea Phase 3
Completed NCT01426269 - Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo Phase 4
Completed NCT00991198 - The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage Phase 2
Terminated NCT04336163 - Skin Imaging to Inform Laser Treatments N/A
Recruiting NCT04108897 - Analysis of the Microbiome in Rosacea Early Phase 1
Completed NCT03872050 - Deep Phenotyping of Rosacea and Migraine
Active, not recruiting NCT06033352 - Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea Phase 2
Completed NCT03263273 - Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea Phase 2
Completed NCT04508660 - CGB-400 for the Reduction of Facial Redness Phase 1
Completed NCT04508205 - CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes Phase 1
Completed NCT05094700 - A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants N/A
Active, not recruiting NCT03211585 - EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA N/A
Completed NCT02576847 - Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel Phase 3
Completed NCT02576860 - Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle Phase 3
Completed NCT02637232 - Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)
Completed NCT02583009 - A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea Phase 2