Trial Outcomes & Findings for Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation (NCT NCT01398280)
NCT ID: NCT01398280
Last Updated: 2019-09-13
Results Overview
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.
COMPLETED
EARLY_PHASE1
15 participants
Up to 12 weeks
2019-09-13
Participant Flow
Participant milestones
| Measure |
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 KLK activity and LL-37 expression.
Vehicle cream: Vehicle cream moisturizer twice daily for up to 12 weeks
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
11
|
|
Overall Study
COMPLETED
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation
Baseline characteristics by cohort
| Measure |
Aminocaproic Acid (ACA)
n=11 Participants
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.
|
Vehicle Cream
n=4 Participants
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
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 18.5 • n=99 Participants
|
63 years
STANDARD_DEVIATION 5.6 • n=107 Participants
|
55.7 years
STANDARD_DEVIATION 16.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksSerine 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.
Outcome measures
| Measure |
Aminocaproic Acid (ACA)
n=7 Participants
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.
|
Vehicle Cream
n=4 Participants
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
|
|---|---|---|
|
Kallikrein 5 (KLK5) Protease Activity
|
581.1 RFU/uL
Standard Deviation 261.0
|
816.5 RFU/uL
Standard Deviation 422.4
|
Adverse Events
Aminocaproic Acid (ACA)
Vehicle Cream
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
UCSD Dermatology Clinical Trials Manager
UCSD Dermatology Clinical Trials
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place