Trial Outcomes & Findings for PK and DPK of Lidocaine Dermal Products (NCT NCT03145207)
NCT ID: NCT03145207
Last Updated: 2020-07-09
Results Overview
maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
14 participants
Primary outcome timeframe
six study sessions for each participant; through 15 h each study session
Results posted on
2020-07-09
Participant Flow
Participant milestones
| Measure |
Lidocaine
Session 1-name brand patch Session 2-generic lidocaine patch Session 3-name brand patch with early heat application Session 4-name brand patch with late heat application Session 5-generic patch with early heat application Session 6-generic patch with late heat application Session 7-name brand and generic lidocaine patch pieces with skin tape stripping
The same 12 volunteers completed each of the seven study sessions.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Lidocaine
Session 1-name brand patch Session 2-generic lidocaine patch Session 3-name brand patch with early heat application Session 4-name brand patch with late heat application Session 5-generic patch with early heat application Session 6-generic patch with late heat application Session 7-name brand and generic lidocaine patch pieces with skin tape stripping
The same 12 volunteers completed each of the seven study sessions.
|
|---|---|
|
Overall Study
volunteer started taking allergy shots
|
1
|
|
Overall Study
baseline blood pressure high
|
1
|
Baseline Characteristics
PK and DPK of Lidocaine Dermal Products
Baseline characteristics by cohort
| Measure |
Lidocaine
n=14 Participants
Session 1-name brand patch Session 2-generic lidocaine patch Session 3-name brand patch with early heat application Session 4-name brand patch with late heat application Session 5-generic patch with early heat application Session 6-generic patch with late heat application Session 7-name brand and generic lidocaine patch pieces with skin tape stripping
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.14 years
STANDARD_DEVIATION 7.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: six study sessions for each participant; through 15 h each study sessionmaximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered
Outcome measures
| Measure |
Lidocaine Name Brand Patch
n=12 Participants
Session 1-name brand patch
|
Lidocaine Generic Patch
n=12 Participants
Session 2-generic lidocaine patch
|
Lidocaine Name Brand Patch Early Heat
n=12 Participants
Session 3-name brand patch with early heat application
|
Lidocaine Name Brand Patch Late Heat
n=12 Participants
Session 4-name brand patch with late heat application
|
Lidocaine Generic Early Heat
n=12 Participants
Session 5-generic patch with early heat application Session 6-generic patch with late heat application Session 7-name brand and generic lidocaine patch pieces with skin tape stripping
|
Lidocaine Generic Late Heat
n=12 Participants
Session 6-generic patch with late heat application
|
|---|---|---|---|---|---|---|
|
Measurement of Maximum Serum Concentration (Cmax)
|
306.8 ng/mL
Standard Deviation 756.3
|
214.9 ng/mL
Standard Deviation 280.5
|
390.76 ng/mL
Standard Deviation 387.29
|
286.49 ng/mL
Standard Deviation 288.59
|
368.09 ng/mL
Standard Deviation 348.93
|
314.95 ng/mL
Standard Deviation 287.36
|
Adverse Events
Name Brand Patch
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Generic Patch
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Name Brand Patch-early
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Name Brand Patch-late
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Generic Patch-early
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Generic Patch-late
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Both Patches
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Name Brand Patch
n=14 participants at risk
name brand lidocaine patch
Lidocaine patch: lidocaine patch
|
Generic Patch
n=14 participants at risk
generic lidocaine patch
Lidocaine patch: lidocaine patch
|
Name Brand Patch-early
n=13 participants at risk
name brand lidocaine patch-early
Lidocaine patch: lidocaine patch
|
Name Brand Patch-late
n=13 participants at risk
name brand lidocaine patch-late
Lidocaine patch: lidocaine patch
|
Generic Patch-early
n=12 participants at risk
generic lidocaine patch-early
Lidocaine patch: lidocaine patch
|
Generic Patch-late
n=12 participants at risk
generic lidocaine patch-late
Lidocaine patch: lidocaine patch
|
Both Patches
n=12 participants at risk
brand name and generic lidocaine patch
Lidocaine patch: lidocaine patch
|
|---|---|---|---|---|---|---|---|
|
General disorders
headache
|
0.00%
0/14 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/14 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/13 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/13 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
8.3%
1/12 • Number of events 1 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
|
General disorders
nausea
|
0.00%
0/14 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/14 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/13 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/13 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
8.3%
1/12 • Number of events 1 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
|
General disorders
decreased heart rate
|
14.3%
2/14 • Number of events 2 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
7.1%
1/14 • Number of events 1 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
7.7%
1/13 • Number of events 1 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/13 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
8.3%
1/12 • Number of events 1 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
|
General disorders
increased respiratory rate
|
7.1%
1/14 • Number of events 1 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/14 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/13 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/13 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
|
General disorders
decreased blood pressure
|
28.6%
4/14 • Number of events 4 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
14.3%
2/14 • Number of events 2 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
38.5%
5/13 • Number of events 5 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
30.8%
4/13 • Number of events 4 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
25.0%
3/12 • Number of events 3 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
50.0%
6/12 • Number of events 6 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
33.3%
4/12 • Number of events 4 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
|
General disorders
increased blood pressure
|
14.3%
2/14 • Number of events 2 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
14.3%
2/14 • Number of events 2 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
7.7%
1/13 • Number of events 1 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
8.3%
1/12 • Number of events 1 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
16.7%
2/12 • Number of events 2 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
|
General disorders
skin itching
|
0.00%
0/14 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/14 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/13 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/13 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
8.3%
1/12 • Number of events 1 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
8.3%
1/12 • Number of events 1 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
|
General disorders
hyperpigmentation
|
0.00%
0/14 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/14 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/13 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/13 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
0.00%
0/12 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
58.3%
7/12 • Number of events 7 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
|
General disorders
erythema
|
42.9%
6/14 • Number of events 6 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
28.6%
4/14 • Number of events 4 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
46.2%
6/13 • Number of events 6 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
46.2%
6/13 • Number of events 6 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
41.7%
5/12 • Number of events 5 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
75.0%
9/12 • Number of events 9 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
66.7%
8/12 • Number of events 8 • TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days)
|
Additional Information
Dr. Audra Stinchcomb
University of Maryland, Baltimore School of Pharmacy
Phone: 410-706-2646
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place