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

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ClinicalTrials.gov Identifier: NCT01398280
Recruitment Status : Completed
First Posted : July 20, 2011
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Tissa Hata, MD, University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Rosacea
Interventions Drug: Topical aminocaproic acid (ACA) mixed with Vanicream
Drug: Vehicle cream
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aminocaproic Acid (ACA) Vehicle Cream
Hide Arm/Group Description

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.

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 KLK activity and LL-37 expression.

Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks

Period Title: Overall Study
Started 11 4
Completed 7 4
Not Completed 4 0
Arm/Group Title Aminocaproic Acid (ACA) Vehicle Cream Total
Hide Arm/Group Description

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.

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 KLK activity and LL-37 expression.

Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks

Total of all reporting groups
Overall Number of Baseline Participants 11 4 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 4 participants 15 participants
53  (18.5) 63  (5.6) 55.7  (16.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 4 participants 15 participants
Female
7
  63.6%
3
  75.0%
10
  66.7%
Male
4
  36.4%
1
  25.0%
5
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 4 participants 15 participants
Hispanic or Latino
2
  18.2%
1
  25.0%
3
  20.0%
Not Hispanic or Latino
6
  54.5%
2
  50.0%
8
  53.3%
Unknown or Not Reported
3
  27.3%
1
  25.0%
4
  26.7%
1.Primary Outcome
Title Kallikrein 5 (KLK5) Protease Activity
Hide 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.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aminocaproic Acid (ACA) Vehicle Cream
Hide Arm/Group Description:

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.

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 KLK activity and LL-37 expression.

Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks

Overall Number of Participants Analyzed 7 4
Mean (Standard Deviation)
Unit of Measure: RFU/uL
581.1  (261.0) 816.5  (422.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aminocaproic Acid (ACA) Vehicle Cream
Hide Arm/Group Description

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.

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 KLK activity and LL-37 expression.

Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks

All-Cause Mortality
Aminocaproic Acid (ACA) Vehicle Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Aminocaproic Acid (ACA) Vehicle Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aminocaproic Acid (ACA) Vehicle Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/4 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCSD Dermatology Clinical Trials Manager
Organization: UCSD Dermatology Clinical Trials
Phone: (858)657-8390
EMail: dermstudies@ucsd.edu
Layout table for additonal information
Responsible Party: Tissa Hata, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01398280     History of Changes
Other Study ID Numbers: 100867
First Submitted: July 19, 2011
First Posted: July 20, 2011
Results First Submitted: June 4, 2019
Results First Posted: September 13, 2019
Last Update Posted: September 13, 2019