Trial Outcomes & Findings for Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds (NCT NCT03365934)
NCT ID: NCT03365934
Last Updated: 2019-06-04
Results Overview
Swabs will be collected on the back at Baseline (Day 0) and analyzed to determine the total number of different bacterial taxa (microorganisms) detected in the sample. There was no prespecified primary endpoint in the protocol.
COMPLETED
NA
35 participants
Baseline (Day 0)
2019-06-04
Participant Flow
Participant milestones
| Measure |
All Randomized Subjects
All Randomized Subjects
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
All Randomized Subjects
All Randomized Subjects
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds
Baseline characteristics by cohort
| Measure |
All Randomized Subjects
n=35 Participants
All Randomized Subjects
|
|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
North America · USA
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0)Swabs will be collected on the back at Baseline (Day 0) and analyzed to determine the total number of different bacterial taxa (microorganisms) detected in the sample. There was no prespecified primary endpoint in the protocol.
Outcome measures
| Measure |
Intact Uncovered Skin
n=29 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=22 Participants
Wounded Uncovered Skin
|
Product #1
n=28 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=23 Participants
Product #3
|
Product #4
n=27 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Richness - Baseline (Day 0)
|
56.5862069 Number of bacterial taxa
Interval 41.82700101 to 71.34541279
|
32.13043478 Number of bacterial taxa
Interval 21.71828318 to 42.54258639
|
43.72413793 Number of bacterial taxa
Interval 31.41567266 to 56.0326032
|
34.03703704 Number of bacterial taxa
Interval 25.21769482 to 42.85637925
|
42.39130435 Number of bacterial taxa
Interval 28.2925728 to 56.4900359
|
46.48148148 Number of bacterial taxa
Interval 32.28761284 to 60.67535013
|
PRIMARY outcome
Timeframe: Day 1Swabs will be collected on the back at Day 1 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Outcome measures
| Measure |
Intact Uncovered Skin
n=32 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=29 Participants
Wounded Uncovered Skin
|
Product #1
n=27 Participants
Product #1
|
Product #2
n=32 Participants
Product #2
|
Product #3
n=19 Participants
Product #3
|
Product #4
n=24 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Richness - (Day 1)
|
53.15625 Number of bacterial taxa
Interval 38.21010189 to 68.10239811
|
58.75862069 Number of bacterial taxa
Interval 47.10408916 to 70.41315222
|
22 Number of bacterial taxa
Interval 18.01079945 to 25.98920055
|
53.5 Number of bacterial taxa
Interval 37.61649637 to 69.38350363
|
42.47368421 Number of bacterial taxa
Interval 27.00391618 to 57.94345224
|
28.83333333 Number of bacterial taxa
Interval 20.99591479 to 36.67075187
|
PRIMARY outcome
Timeframe: Day 2Swabs will be collected on the back at Day 2 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Outcome measures
| Measure |
Intact Uncovered Skin
n=32 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=33 Participants
Product #1
|
Product #2
n=32 Participants
Product #2
|
Product #3
n=27 Participants
Product #3
|
Product #4
n=32 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Richness - (Day 2)
|
60.15625 Number of bacterial taxa
Interval 45.95442154 to 74.35807846
|
87.03030303 Number of bacterial taxa
Interval 64.50676969 to 109.5538364
|
20.33333333 Number of bacterial taxa
Interval 15.69936368 to 24.96730299
|
36.65625 Number of bacterial taxa
Interval 30.26643624 to 43.04606376
|
33.7037037 Number of bacterial taxa
Interval 22.14710131 to 45.2603061
|
30.40625 Number of bacterial taxa
Interval 23.74762413 to 37.06487587
|
PRIMARY outcome
Timeframe: Day 3Swabs will be collected on the back at Day 3 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Outcome measures
| Measure |
Intact Uncovered Skin
n=29 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=32 Participants
Wounded Uncovered Skin
|
Product #1
n=33 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=25 Participants
Product #3
|
Product #4
n=32 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Richness - (Day 3)
|
53.44827586 Number of bacterial taxa
Interval 40.61259145 to 66.28396027
|
74.03125 Number of bacterial taxa
Interval 60.80846371 to 87.25403629
|
19.21212121 Number of bacterial taxa
Interval 16.49174219 to 21.93250024
|
38.25925926 Number of bacterial taxa
Interval 29.78367344 to 46.73484508
|
37.88 Number of bacterial taxa
Interval 23.44927006 to 52.31072994
|
30.28125 Number of bacterial taxa
Interval 23.87137083 to 36.69112917
|
PRIMARY outcome
Timeframe: Day 4Swabs will be collected on the back at Day 4 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Outcome measures
| Measure |
Intact Uncovered Skin
n=26 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=30 Participants
Wounded Uncovered Skin
|
Product #1
n=32 Participants
Product #1
|
Product #2
n=31 Participants
Product #2
|
Product #3
n=28 Participants
Product #3
|
Product #4
n=32 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Richness - (Day 4)
|
66.88461538 Number of bacterial taxa
Interval 47.31497155 to 86.45425922
|
76.23333333 Number of bacterial taxa
Interval 61.4245631 to 91.04210357
|
20.5 Number of bacterial taxa
Interval 17.18168127 to 23.81831873
|
44.35483871 Number of bacterial taxa
Interval 33.45042213 to 55.25925529
|
43.53571429 Number of bacterial taxa
Interval 29.33570468 to 57.73572389
|
25.59375 Number of bacterial taxa
Interval 20.71187082 to 30.47562918
|
PRIMARY outcome
Timeframe: Day 5Swabs will be collected on the back at Day 5 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Outcome measures
| Measure |
Intact Uncovered Skin
n=25 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=27 Participants
Wounded Uncovered Skin
|
Product #1
n=31 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=21 Participants
Product #3
|
Product #4
n=31 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Richness - (Day 5)
|
61.96 Number of bacterial taxa
Interval 44.36091054 to 79.55908946
|
77.59259259 Number of bacterial taxa
Interval 60.00060441 to 95.18458078
|
19.03225806 Number of bacterial taxa
Interval 16.42738215 to 21.63713398
|
44.03703704 Number of bacterial taxa
Interval 29.83167678 to 58.2423973
|
50.33333333 Number of bacterial taxa
Interval 32.41789542 to 68.24877125
|
25.80645161 Number of bacterial taxa
Interval 21.1508763 to 30.46202693
|
PRIMARY outcome
Timeframe: Day 6Swabs will be collected on the back at Day 6 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Outcome measures
| Measure |
Intact Uncovered Skin
n=18 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=27 Participants
Wounded Uncovered Skin
|
Product #1
n=29 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=19 Participants
Product #3
|
Product #4
n=30 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Richness - (Day 6)
|
48.5 Number of bacterial taxa
Interval 35.54549519 to 61.45450481
|
75.88888889 Number of bacterial taxa
Interval 61.54822817 to 90.2295496
|
23.55172414 Number of bacterial taxa
Interval 20.03657535 to 27.06687293
|
48.81481481 Number of bacterial taxa
Interval 37.40801959 to 60.22161004
|
40.26315789 Number of bacterial taxa
Interval 26.53167948 to 53.99463631
|
25.63333333 Number of bacterial taxa
Interval 21.01769583 to 30.24897084
|
PRIMARY outcome
Timeframe: Day 7Swabs will be collected on the back at Day 7 and analyzed to determine the total number of different bacteria Taxa (microorganismss) detected in the sample.
Outcome measures
| Measure |
Intact Uncovered Skin
n=22 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=31 Participants
Product #1
|
Product #2
n=25 Participants
Product #2
|
Product #3
n=21 Participants
Product #3
|
Product #4
n=33 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Richness - (Day 7)
|
54.54545455 Number of bacterial taxa
Interval 40.08770259 to 69.0032065
|
81.51515152 Number of bacterial taxa
Interval 62.74620188 to 100.2841011
|
31 Number of bacterial taxa
Interval 23.08861196 to 38.91138804
|
45.12 Number of bacterial taxa
Interval 28.23285287 to 62.00714713
|
43.04761905 Number of bacterial taxa
Interval 27.89745068 to 58.19778741
|
30.57575758 Number of bacterial taxa
Interval 24.32822886 to 36.82328629
|
PRIMARY outcome
Timeframe: Day 14Swabs will be collected on the back at Day 14 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Outcome measures
| Measure |
Intact Uncovered Skin
n=30 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=27 Participants
Wounded Uncovered Skin
|
Product #1
n=32 Participants
Product #1
|
Product #2
n=32 Participants
Product #2
|
Product #3
n=25 Participants
Product #3
|
Product #4
n=33 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Richness - (Day 14)
|
73.1 Number of bacterial taxa
Interval 57.23395854 to 88.96604146
|
66.44444444 Number of bacterial taxa
Interval 48.7698287 to 84.11906019
|
28.34375 Number of bacterial taxa
Interval 24.26615289 to 32.42134711
|
46.21875 Number of bacterial taxa
Interval 39.38246899 to 53.05503101
|
32.32 Number of bacterial taxa
Interval 25.7083049 to 38.9316951
|
30.45454545 Number of bacterial taxa
Interval 25.6128987 to 35.29619221
|
PRIMARY outcome
Timeframe: Baseline (Day 0)Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Shannon Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=29 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=22 Participants
Wounded Uncovered Skin
|
Product #1
n=28 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=23 Participants
Product #3
|
Product #4
n=27 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Diversity - Baseline (Day 0)
|
1.702946961 Shannon Diversity Index
Interval 1.212183074 to 2.193710849
|
0.938913363 Shannon Diversity Index
Interval 0.465348751 to 1.412477975
|
1.470084856 Shannon Diversity Index
Interval 1.011374271 to 1.928795441
|
1.16250018 Shannon Diversity Index
Interval 0.709007612 to 1.615992753
|
1.355575793 Shannon Diversity Index
Interval 0.832569386 to 1.8785822
|
1.278886018 Shannon Diversity Index
Interval 0.840487425 to 1.717284611
|
PRIMARY outcome
Timeframe: Day 1Swabs will be collected on the back at Day 1 for analysis based on the Shannon Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=32 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=29 Participants
Wounded Uncovered Skin
|
Product #1
n=27 Participants
Product #1
|
Product #2
n=32 Participants
Product #2
|
Product #3
n=19 Participants
Product #3
|
Product #4
n=24 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Diversity - Day 1
|
1.703357647 Shannon Diversity Index
Interval 1.261265404 to 2.145449891
|
1.45014401 Shannon Diversity Index
Interval 1.047686471 to 1.852601549
|
0.786918525 Shannon Diversity Index
Interval 0.546103958 to 1.027733092
|
1.518890457 Shannon Diversity Index
Interval 1.116626746 to 1.921154169
|
1.060560749 Shannon Diversity Index
Interval 0.544639084 to 1.576482413
|
0.900390717 Shannon Diversity Index
Interval 0.622715277 to 1.178066157
|
PRIMARY outcome
Timeframe: Day 2Swabs will be collected on the back at Day 2 for analysis based on the Shannon Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=32 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=33 Participants
Product #1
|
Product #2
n=32 Participants
Product #2
|
Product #3
n=27 Participants
Product #3
|
Product #4
n=32 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Diversity - Day 2
|
1.776794637 Shannon Diversity Index
Interval 1.324060973 to 2.229528302
|
1.866171013 Shannon Diversity Index
Interval 1.449444421 to 2.282897605
|
0.793586986 Shannon Diversity Index
Interval 0.62136427 to 0.965809702
|
1.169519236 Shannon Diversity Index
Interval 0.888383719 to 1.450654753
|
1.327096148 Shannon Diversity Index
Interval 0.903682194 to 1.750510103
|
0.941432164 Shannon Diversity Index
Interval 0.692964696 to 1.189899633
|
PRIMARY outcome
Timeframe: Day 3Swabs will be collected on the back at Day 3 for analysis based on the Shannon Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=29 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=32 Participants
Wounded Uncovered Skin
|
Product #1
n=33 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=25 Participants
Product #3
|
Product #4
n=32 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Diversity - Day 3
|
1.85115546 Shannon Diversity Index
Interval 1.382317602 to 2.319993318
|
1.765408531 Shannon Diversity Index
Interval 1.338653068 to 2.192163994
|
0.7122095 Shannon Diversity Index
Interval 0.538547591 to 0.885871409
|
1.046670711 Shannon Diversity Index
Interval 0.736643325 to 1.356698098
|
1.322070974 Shannon Diversity Index
Interval 0.943427192 to 1.700714756
|
1.071628134 Shannon Diversity Index
Interval 0.813088017 to 1.330168251
|
PRIMARY outcome
Timeframe: Day 4Swabs will be collected on the back at Day 4 for analysis based on the Shannon Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=26 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=30 Participants
Wounded Uncovered Skin
|
Product #1
n=32 Participants
Product #1
|
Product #2
n=31 Participants
Product #2
|
Product #3
n=28 Participants
Product #3
|
Product #4
n=32 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Diversity - Day 4
|
1.932633093 Shannon Diversity Index
Interval 1.431535105 to 2.433731082
|
1.88044173 Shannon Diversity Index
Interval 1.433470325 to 2.327413134
|
0.797557627 Shannon Diversity Index
Interval 0.628526357 to 0.966588896
|
1.453888326 Shannon Diversity Index
Interval 1.117071932 to 1.790704721
|
1.513528952 Shannon Diversity Index
Interval 1.052864028 to 1.974193877
|
0.76492761 Shannon Diversity Index
Interval 0.567335326 to 0.962519895
|
PRIMARY outcome
Timeframe: Day 5Swabs will be collected on the back at Day 5 for analysis based on the Shannon Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=25 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=27 Participants
Wounded Uncovered Skin
|
Product #1
n=31 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=21 Participants
Product #3
|
Product #4
n=31 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Diversity - Day 5
|
1.783329786 Shannon Diversity Index
Interval 1.22306299 to 2.343596582
|
1.664197367 Shannon Diversity Index
Interval 1.212563987 to 2.115830748
|
0.700642641 Shannon Diversity Index
Interval 0.529568098 to 0.871717184
|
1.267584901 Shannon Diversity Index
Interval 0.901217742 to 1.633952061
|
1.480613855 Shannon Diversity Index
Interval 0.994345968 to 1.966881743
|
0.68710958 Shannon Diversity Index
Interval 0.515014462 to 0.859204698
|
PRIMARY outcome
Timeframe: Day 6Swabs will be collected on the back at Day 6 for analysis based on the Shannon Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=18 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=27 Participants
Wounded Uncovered Skin
|
Product #1
n=29 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=19 Participants
Product #3
|
Product #4
n=30 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Diversity - Day 6
|
1.782776526 Shannon Diversity Index
Interval 1.184618285 to 2.380934768
|
1.799754753 Shannon Diversity Index
Interval 1.346147213 to 2.253362293
|
0.865721173 Shannon Diversity Index
Interval 0.642359805 to 1.089082541
|
1.223240388 Shannon Diversity Index
Interval 0.927644983 to 1.518835794
|
1.425318411 Shannon Diversity Index
Interval 0.881697663 to 1.968939159
|
0.698409234 Shannon Diversity Index
Interval 0.484505139 to 0.912313329
|
PRIMARY outcome
Timeframe: Day 7Swabs will be collected on the back at Day 7 for analysis based on the Shannon Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=22 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=31 Participants
Product #1
|
Product #2
n=25 Participants
Product #2
|
Product #3
n=21 Participants
Product #3
|
Product #4
n=33 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Diversity - Day 7
|
1.637800497 Shannon Diversity Index
Interval 1.118090334 to 2.15751066
|
1.765588383 Shannon Diversity Index
Interval 1.340278816 to 2.190897951
|
0.848189016 Shannon Diversity Index
Interval 0.629210776 to 1.067167257
|
1.328769036 Shannon Diversity Index
Interval 0.915319287 to 1.742218786
|
1.367835908 Shannon Diversity Index
Interval 0.901653933 to 1.834017883
|
0.791935871 Shannon Diversity Index
Interval 0.565396501 to 1.018475241
|
PRIMARY outcome
Timeframe: Day 14Swabs will be collected on the back at Day 14 for analysis based on the Shannon Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=30 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=27 Participants
Wounded Uncovered Skin
|
Product #1
n=32 Participants
Product #1
|
Product #2
n=32 Participants
Product #2
|
Product #3
n=25 Participants
Product #3
|
Product #4
n=33 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Diversity - Day 14
|
1.992920174 Shannon Diversity Index
Interval 1.528772641 to 2.457067706
|
1.729295419 Shannon Diversity Index
Interval 1.273786002 to 2.184804836
|
0.826824832 Shannon Diversity Index
Interval 0.642994336 to 1.010655328
|
1.188271444 Shannon Diversity Index
Interval 0.950876818 to 1.42566607
|
1.362870394 Shannon Diversity Index
Interval 0.978315938 to 1.747424849
|
0.729090928 Shannon Diversity Index
Interval 0.540015069 to 0.918166787
|
PRIMARY outcome
Timeframe: Day 0Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Pielou's Evenness Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=29 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=22 Participants
Wounded Uncovered Skin
|
Product #1
n=28 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=23 Participants
Product #3
|
Product #4
n=27 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Evenness - Baseline (Day 0)
|
0.410155753 Pielou's Evenness Index
Interval 0.305407316 to 0.51490419
|
0.271955307 Pielou's Evenness Index
Interval 0.143543228 to 0.400367386
|
0.402950073 Pielou's Evenness Index
Interval 0.37196059 to 0.518890538
|
0.320061269 Pielou's Evenness Index
Interval 0.201925423 to 0.438197114
|
0.358334602 Pielou's Evenness Index
Interval 0.228095257 to 0.488573947
|
0.325047059 Pielou's Evenness Index
Interval 0.217282735 to 0.432811384
|
PRIMARY outcome
Timeframe: Day 1Swabs will be collected on the back at Day 1 for analysis based on the Pielou's Evenness Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=32 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=29 Participants
Wounded Uncovered Skin
|
Product #1
n=27 Participants
Product #1
|
Product #2
n=32 Participants
Product #2
|
Product #3
n=19 Participants
Product #3
|
Product #4
n=24 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Evenness - Day 1
|
0.437132278 Pielou's Evenness Index
Interval 0.330359027 to 0.54390553
|
0.349459879 Pielou's Evenness Index
Interval 0.255994131 to 0.442925627
|
0.246062404 Pielou's Evenness Index
Interval 0.173290416 to 0.318834392
|
0.389333736 Pielou's Evenness Index
Interval 0.294031092 to 0.484636381
|
0.273028286 Pielou's Evenness Index
Interval 0.154944552 to 0.391112019
|
0.265726584 Pielou's Evenness Index
Interval 0.192716814 to 0.338736354
|
PRIMARY outcome
Timeframe: Day 2Swabs will be collected on the back at Day 2 for analysis based on the Pielou's Evenness Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=32 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=33 Participants
Product #1
|
Product #2
n=32 Participants
Product #2
|
Product #3
n=27 Participants
Product #3
|
Product #4
n=32 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Evenness - Day 2
|
0.42693493 Pielou's Evenness Index
Interval 0.32874755 to 0.52512231
|
0.415386732 Pielou's Evenness Index
Interval 0.332645201 to 0.498128264
|
0.263575452 Pielou's Evenness Index
Interval 0.212813889 to 0.314337015
|
0.322568391 Pielou's Evenness Index
Interval 0.249971799 to 0.395164982
|
0.386309873 Pielou's Evenness Index
Interval 0.276870199 to 0.495749548
|
0.277342605 Pielou's Evenness Index
Interval 0.212258941 to 0.342426269
|
PRIMARY outcome
Timeframe: Day 3Swabs will be collected on the back at Day 3 for analysis based on the Pielou's Evenness Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=29 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=32 Participants
Wounded Uncovered Skin
|
Product #1
n=33 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=25 Participants
Product #3
|
Product #4
n=32 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Evenness - Day 3
|
0.455666826 Pielou's Evenness Index
Interval 0.348282864 to 0.563050789
|
0.405262792 Pielou's Evenness Index
Interval 0.310526103 to 0.49999948
|
0.234966957 Pielou's Evenness Index
Interval 0.183226948 to 0.286706967
|
0.279414327 Pielou's Evenness Index
Interval 0.204200672 to 0.354627983
|
0.363143499 Pielou's Evenness Index
Interval 0.268134344 to 0.458152655
|
0.312661752 Pielou's Evenness Index
Interval 0.250785086 to 0.374538417
|
PRIMARY outcome
Timeframe: Day 4Swabs will be collected on the back at Day 4 for analysis based on the Pielou's Evenness Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=26 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=30 Participants
Wounded Uncovered Skin
|
Product #1
n=32 Participants
Product #1
|
Product #2
n=31 Participants
Product #2
|
Product #3
n=28 Participants
Product #3
|
Product #4
n=32 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Evenness - Day 4
|
0.451377803 Pielou's Evenness Index
Interval 0.350796707 to 0.5519589
|
0.422737764 Pielou's Evenness Index
Interval 0.328361231 to 0.517114298
|
0.269049335 Pielou's Evenness Index
Interval 0.216107994 to 0.321990676
|
0.38804873 Pielou's Evenness Index
Interval 0.312100017 to 0.463997444
|
0.392633921 Pielou's Evenness Index
Interval 0.288519448 to 0.496748395
|
0.231556861 Pielou's Evenness Index
Interval 0.177760893 to 0.285352829
|
PRIMARY outcome
Timeframe: Day 5Swabs will be collected on the back at Day 5 for analysis based on the Pielou's Evenness Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=25 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=27 Participants
Wounded Uncovered Skin
|
Product #1
n=31 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=21 Participants
Product #3
|
Product #4
n=31 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Evenness - Day 5
|
0.418779366 Pielou's Evenness Index
Interval 0.300422474 to 0.537136258
|
0.377673266 Pielou's Evenness Index
Interval 0.28316356 to 0.472182971
|
0.235666776 Pielou's Evenness Index
Interval 0.181164664 to 0.290168889
|
0.330181203 Pielou's Evenness Index
Interval 0.249683185 to 0.410679222
|
0.388971323 Pielou's Evenness Index
Interval 0.268970894 to 0.508971751
|
0.212340111 Pielou's Evenness Index
Interval 0.163649748 to 0.261030475
|
PRIMARY outcome
Timeframe: Day 6Swabs will be collected on the back at Day 6 for analysis based on the Pielou's Evenness Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=18 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=27 Participants
Wounded Uncovered Skin
|
Product #1
n=29 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=19 Participants
Product #3
|
Product #4
n=30 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Evenness - Day 6
|
0.446298915 Pielou's Evenness Index
Interval 0.307295525 to 0.585302305
|
0.417003638 Pielou's Evenness Index
Interval 0.315872307 to 0.51813497
|
0.270297461 Pielou's Evenness Index
Interval 0.208318912 to 0.33227601
|
0.31595456 Pielou's Evenness Index
Interval 0.242353894 to 0.389555227
|
0.370960196 Pielou's Evenness Index
Interval 0.242456263 to 0.499464128
|
0.213078749 Pielou's Evenness Index
Interval 0.150385636 to 0.275771862
|
PRIMARY outcome
Timeframe: Day 7Swabs will be collected on the back at Day 7 for analysis based on the Pielou's Evenness Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=22 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=31 Participants
Product #1
|
Product #2
n=25 Participants
Product #2
|
Product #3
n=21 Participants
Product #3
|
Product #4
n=33 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Evenness - Day 7
|
0.410567291 Pielou's Evenness Index
Interval 0.286544213 to 0.534590369
|
0.404030653 Pielou's Evenness Index
Interval 0.309872763 to 0.498188542
|
0.247507869 Pielou's Evenness Index
Interval 0.190648545 to 0.304367193
|
0.354717133 Pielou's Evenness Index
Interval 0.259034665 to 0.450399602
|
0.359914043 Pielou's Evenness Index
Interval 0.242240002 to 0.477588085
|
0.230659131 Pielou's Evenness Index
Interval 0.174438405 to 0.286879856
|
PRIMARY outcome
Timeframe: Day 14Swabs will be collected on the back at Day 14 for analysis based on the Pielou's Evenness Index.
Outcome measures
| Measure |
Intact Uncovered Skin
n=30 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=27 Participants
Wounded Uncovered Skin
|
Product #1
n=32 Participants
Product #1
|
Product #2
n=32 Participants
Product #2
|
Product #3
n=25 Participants
Product #3
|
Product #4
n=33 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Microbial Community Evenness - Day 14
|
0.454253238 Pielou's Evenness Index
Interval 0.360645958 to 0.547860518
|
0.402829439 Pielou's Evenness Index
Interval 0.309226175 to 0.496432702
|
0.249502521 Pielou's Evenness Index
Interval 0.196421318 to 0.302583723
|
0.308795465 Pielou's Evenness Index
Interval 0.25494207 to 0.362648861
|
0.383110745 Pielou's Evenness Index
Interval 0.283994153 to 0.482227337
|
0.210741952 Pielou's Evenness Index
Interval 0.159426533 to 0.262057372
|
SECONDARY outcome
Timeframe: Day 0The skin barrier function of the test sites will be evaluated at Baseline (Day 0) by Trans Epidermal Water Loss (TEWL).
Outcome measures
| Measure |
Intact Uncovered Skin
n=35 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=35 Participants
Wounded Uncovered Skin
|
Product #1
n=35 Participants
Product #1
|
Product #2
n=35 Participants
Product #2
|
Product #3
n=35 Participants
Product #3
|
Product #4
n=35 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Skin Barrier Function -Baseline (Day 0)
|
9.82 g/m^2/hr
Standard Deviation 6.725
|
96.94 g/m^2/hr
Standard Deviation 11.682
|
101.08 g/m^2/hr
Standard Deviation 9.992
|
97.04 g/m^2/hr
Standard Deviation 13.397
|
101.43 g/m^2/hr
Standard Deviation 11.116
|
98.21 g/m^2/hr
Standard Deviation 13.165
|
SECONDARY outcome
Timeframe: Day 1The skin barrier function of the test sites will be evaluated at Day 1 by Trans Epidermal Water Loss (TEWL).
Outcome measures
| Measure |
Intact Uncovered Skin
n=34 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=34 Participants
Wounded Uncovered Skin
|
Product #1
n=34 Participants
Product #1
|
Product #2
n=34 Participants
Product #2
|
Product #3
n=34 Participants
Product #3
|
Product #4
n=34 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Skin Barrier Function - Day 1
|
13.05 g/m^2/hr
Standard Deviation 13.414
|
95.68 g/m^2/hr
Standard Deviation 16.393
|
92.40 g/m^2/hr
Standard Deviation 10.886
|
91.13 g/m^2/hr
Standard Deviation 14.689
|
97.91 g/m^2/hr
Standard Deviation 14.527
|
97.61 g/m^2/hr
Standard Deviation 15.420
|
SECONDARY outcome
Timeframe: Day 2The skin barrier function of the test sites will be evaluated at Day 2 by Trans Epidermal Water Loss (TEWL).
Outcome measures
| Measure |
Intact Uncovered Skin
n=33 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=33 Participants
Product #1
|
Product #2
n=33 Participants
Product #2
|
Product #3
n=33 Participants
Product #3
|
Product #4
n=33 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Skin Barrier Function - Day 2
|
10.97 g/m^2/hr
Standard Deviation 7.527
|
80.26 g/m^2/hr
Standard Deviation 22.229
|
73.10 g/m^2/hr
Standard Deviation 16.557
|
68.36 g/m^2/hr
Standard Deviation 20.387
|
82.63 g/m^2/hr
Standard Deviation 17.149
|
89.77 g/m^2/hr
Standard Deviation 17.470
|
SECONDARY outcome
Timeframe: Day 3The skin barrier function of the test sites will be evaluated at Day 3 by Trans Epidermal Water Loss (TEWL).
Outcome measures
| Measure |
Intact Uncovered Skin
n=33 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=33 Participants
Product #1
|
Product #2
n=33 Participants
Product #2
|
Product #3
n=33 Participants
Product #3
|
Product #4
n=33 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Skin Barrier Function - Day 3
|
15.46 g/m^2/hr
Standard Deviation 18.864
|
77.40 g/m^2/hr
Standard Deviation 24.567
|
50.41 g/m^2/hr
Standard Deviation 23.291
|
50.81 g/m^2/hr
Standard Deviation 20.377
|
68.49 g/m^2/hr
Standard Deviation 27.025
|
89.27 g/m^2/hr
Standard Deviation 18.969
|
SECONDARY outcome
Timeframe: Day 4The skin barrier function of the test sites will be evaluated at Day 4 by Trans Epidermal Water Loss (TEWL).
Outcome measures
| Measure |
Intact Uncovered Skin
n=34 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=34 Participants
Wounded Uncovered Skin
|
Product #1
n=34 Participants
Product #1
|
Product #2
n=34 Participants
Product #2
|
Product #3
n=34 Participants
Product #3
|
Product #4
n=34 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Skin Barrier Function - Day 4
|
16.70 g/m^2/hr
Standard Deviation 19.227
|
72.49 g/m^2/hr
Standard Deviation 25.078
|
36.32 g/m^2/hr
Standard Deviation 35.19
|
35.19 g/m^2/hr
Standard Deviation 20.969
|
56.14 g/m^2/hr
Standard Deviation 28.921
|
82.46 g/m^2/hr
Standard Deviation 28.101
|
SECONDARY outcome
Timeframe: Day 5The skin barrier function of the test sites will be evaluated at Day 5 by Trans Epidermal Water Loss (TEWL).
Outcome measures
| Measure |
Intact Uncovered Skin
n=33 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=33 Participants
Product #1
|
Product #2
n=33 Participants
Product #2
|
Product #3
n=33 Participants
Product #3
|
Product #4
n=33 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Skin Barrier Function - Day 5
|
12.77 g/m^2/hr
Standard Deviation 16.829
|
58.87 g/m^2/hr
Standard Deviation 25.914
|
30.80 g/m^2/hr
Standard Deviation 21.510
|
32.27 g/m^2/hr
Standard Deviation 23.068
|
44.91 g/m^2/hr
Standard Deviation 32.510
|
67.46 g/m^2/hr
Standard Deviation 27.159
|
SECONDARY outcome
Timeframe: Day 6The skin barrier function of the test sites will be evaluated at Day 6 by Trans Epidermal Water Loss (TEWL).
Outcome measures
| Measure |
Intact Uncovered Skin
n=32 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=32 Participants
Wounded Uncovered Skin
|
Product #1
n=32 Participants
Product #1
|
Product #2
n=32 Participants
Product #2
|
Product #3
n=32 Participants
Product #3
|
Product #4
n=32 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Skin Barrier Function - Day 6
|
11.94 g/m^2/hr
Standard Deviation 8.699
|
47.34 g/m^2/hr
Standard Deviation 20.318
|
21.28 g/m^2/hr
Standard Deviation 8.524
|
22.81 g/m^2/hr
Standard Deviation 11.897
|
31.57 g/m^2/hr
Standard Deviation 17.810
|
53.56 g/m^2/hr
Standard Deviation 28.390
|
SECONDARY outcome
Timeframe: Day 7The skin barrier function of the test sites will be evaluated at Day 7 by Trans Epidermal Water Loss (TEWL).
Outcome measures
| Measure |
Intact Uncovered Skin
n=33 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=33 Participants
Product #1
|
Product #2
n=33 Participants
Product #2
|
Product #3
n=33 Participants
Product #3
|
Product #4
n=33 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Skin Barrier Function - Day 7
|
9.80 g/m^2/hr
Standard Deviation 4.252
|
30.36 g/m^2/hr
Standard Deviation 16.556
|
21.23 g/m^2/hr
Standard Deviation 12.719
|
19.52 g/m^2/hr
Standard Deviation 7.545
|
25.08 g/m^2/hr
Standard Deviation 17.171
|
39.03 g/m^2/hr
Standard Deviation 25.197
|
SECONDARY outcome
Timeframe: Day 14The skin barrier function of the test sites will be evaluated at Day 14 by Trans Epidermal Water Loss (TEWL).
Outcome measures
| Measure |
Intact Uncovered Skin
n=33 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=33 Participants
Product #1
|
Product #2
n=33 Participants
Product #2
|
Product #3
n=33 Participants
Product #3
|
Product #4
n=33 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Skin Barrier Function - Day 14
|
10.32 g/m^2/hr
Standard Deviation 14.697
|
14.58 g/m^2/hr
Standard Deviation 13.016
|
16.66 g/m^2/hr
Standard Deviation 9.356
|
16.10 g/m^2/hr
Standard Deviation 15.442
|
10.07 g/m^2/hr
Standard Deviation 4.165
|
16.45 g/m^2/hr
Standard Deviation 5.432
|
SECONDARY outcome
Timeframe: Day 0Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Outcome measures
| Measure |
Intact Uncovered Skin
n=27 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=30 Participants
Wounded Uncovered Skin
|
Product #1
n=30 Participants
Product #1
|
Product #2
n=30 Participants
Product #2
|
Product #3
n=31 Participants
Product #3
|
Product #4
n=29 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)
|
0.82 Arbitrary Unit
Standard Deviation 0.143
|
0.97 Arbitrary Unit
Standard Deviation 0.189
|
0.96 Arbitrary Unit
Standard Deviation 0.143
|
1.00 Arbitrary Unit
Standard Deviation 0.198
|
0.99 Arbitrary Unit
Standard Deviation 0.171
|
0.98 Arbitrary Unit
Standard Deviation 0.179
|
SECONDARY outcome
Timeframe: Day 1Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Outcome measures
| Measure |
Intact Uncovered Skin
n=25 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=26 Participants
Wounded Uncovered Skin
|
Product #1
n=26 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=27 Participants
Product #3
|
Product #4
n=27 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Redness: Wound Area Oxyhemoglobin Level - Day 1
|
0.83 Arbitrary Unit
Standard Deviation 0.127
|
1.20 Arbitrary Unit
Standard Deviation 0.170
|
1.15 Arbitrary Unit
Standard Deviation 0.181
|
1.12 Arbitrary Unit
Standard Deviation 0.197
|
1.15 Arbitrary Unit
Standard Deviation 0.178
|
1.22 Arbitrary Unit
Standard Deviation 0.186
|
SECONDARY outcome
Timeframe: Day 2Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Outcome measures
| Measure |
Intact Uncovered Skin
n=26 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=27 Participants
Wounded Uncovered Skin
|
Product #1
n=27 Participants
Product #1
|
Product #2
n=27 Participants
Product #2
|
Product #3
n=27 Participants
Product #3
|
Product #4
n=27 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Redness: Wound Area Oxyhemoglobin Level - Day 2
|
0.85 Arbitrary Unit
Standard Deviation 0.100
|
1.21 Arbitrary Unit
Standard Deviation 0.166
|
1.16 Arbitrary Unit
Standard Deviation 0.181
|
1.07 Arbitrary Unit
Standard Deviation 0.188
|
1.18 Arbitrary Unit
Standard Deviation 0.218
|
1.37 Arbitrary Unit
Standard Deviation 0.212
|
SECONDARY outcome
Timeframe: Day 3Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Outcome measures
| Measure |
Intact Uncovered Skin
n=14 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=17 Participants
Wounded Uncovered Skin
|
Product #1
n=16 Participants
Product #1
|
Product #2
n=16 Participants
Product #2
|
Product #3
n=17 Participants
Product #3
|
Product #4
n=15 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Redness: Wound Area Oxyhemoglobin Level - Day 3
|
0.81 Arbitrary Unit
Standard Deviation 0.156
|
1.16 Arbitrary Unit
Standard Deviation 0.211
|
1.08 Arbitrary Unit
Standard Deviation 0.121
|
1.06 Arbitrary Unit
Standard Deviation 0.174
|
1.16 Arbitrary Unit
Standard Deviation 0.160
|
1.33 Arbitrary Unit
Standard Deviation 0.252
|
SECONDARY outcome
Timeframe: Day 4Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Outcome measures
| Measure |
Intact Uncovered Skin
n=31 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=34 Participants
Product #1
|
Product #2
n=34 Participants
Product #2
|
Product #3
n=33 Participants
Product #3
|
Product #4
n=34 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Redness: Wound Area Oxyhemoglobin Level - Day 4
|
0.81 Arbitrary Unit
Standard Deviation 0.138
|
1.20 Arbitrary Unit
Standard Deviation 0.166
|
0.99 Arbitrary Unit
Standard Deviation 0.217
|
0.99 Arbitrary Unit
Standard Deviation 0.205
|
1.14 Arbitrary Unit
Standard Deviation 0.386
|
1.28 Arbitrary Unit
Standard Deviation 0.252
|
SECONDARY outcome
Timeframe: Day 5Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Outcome measures
| Measure |
Intact Uncovered Skin
n=24 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=24 Participants
Wounded Uncovered Skin
|
Product #1
n=23 Participants
Product #1
|
Product #2
n=24 Participants
Product #2
|
Product #3
n=24 Participants
Product #3
|
Product #4
n=23 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Redness: Wound Area Oxyhemoglobin Level - Day 5
|
0.81 Arbitrary Unit
Standard Deviation 0.159
|
1.14 Arbitrary Unit
Standard Deviation 0.208
|
0.90 Arbitrary Unit
Standard Deviation 0.146
|
0.96 Arbitrary Unit
Standard Deviation 0.178
|
1.00 Arbitrary Unit
Standard Deviation 0.207
|
1.26 Arbitrary Unit
Standard Deviation 0.336
|
SECONDARY outcome
Timeframe: Day 6Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Outcome measures
| Measure |
Intact Uncovered Skin
n=30 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=30 Participants
Wounded Uncovered Skin
|
Product #1
n=28 Participants
Product #1
|
Product #2
n=29 Participants
Product #2
|
Product #3
n=29 Participants
Product #3
|
Product #4
n=29 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Redness: Wound Area Oxyhemoglobin Level - Day 6
|
0.80 Arbitrary Unit
Standard Deviation 0.124
|
1.20 Arbitrary Unit
Standard Deviation 0.230
|
0.88 Arbitrary Unit
Standard Deviation 0.146
|
0.95 Arbitrary Unit
Standard Deviation 0.148
|
0.98 Arbitrary Unit
Standard Deviation 0.159
|
1.23 Arbitrary Unit
Standard Deviation 0.326
|
SECONDARY outcome
Timeframe: Day 7Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Outcome measures
| Measure |
Intact Uncovered Skin
n=32 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=33 Participants
Wounded Uncovered Skin
|
Product #1
n=33 Participants
Product #1
|
Product #2
n=33 Participants
Product #2
|
Product #3
n=33 Participants
Product #3
|
Product #4
n=33 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Redness: Wound Area Oxyhemoglobin Level - Day 7
|
0.78 Arbitrary Unit
Standard Deviation 0.111
|
1.02 Arbitrary Unit
Standard Deviation 0.191
|
0.88 Arbitrary Unit
Standard Deviation 0.164
|
0.89 Arbitrary Unit
Standard Deviation 0.151
|
0.88 Arbitrary Unit
Standard Deviation 0.141
|
1.03 Arbitrary Unit
Standard Deviation 0.279
|
SECONDARY outcome
Timeframe: Day 14Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Outcome measures
| Measure |
Intact Uncovered Skin
n=29 Participants
Intact Uncovered Skin
|
Wounded Uncovered Skin
n=30 Participants
Wounded Uncovered Skin
|
Product #1
n=28 Participants
Product #1
|
Product #2
n=29 Participants
Product #2
|
Product #3
n=29 Participants
Product #3
|
Product #4
n=29 Participants
Product #4
|
|---|---|---|---|---|---|---|
|
Redness: Wound Area Oxyhemoglobin Level - Day 14
|
0.79 Arbitrary Unit
Standard Deviation 0.120
|
0.90 Arbitrary Unit
Standard Deviation 0.147
|
0.89 Arbitrary Unit
Standard Deviation 0.146
|
0.85 Arbitrary Unit
Standard Deviation 0.125
|
0.84 Arbitrary Unit
Standard Deviation 0.112
|
0.92 Arbitrary Unit
Standard Deviation 0.115
|
Adverse Events
All Randomized Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER