Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds

Randomized, Exploratory Study to Evaluate Changes to Skin Microbiome With Tape-stripped Wounds

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03365934

Enrollment

Registered

2017-12-08

Start date

2017-11-20

Completion date

2018-02-12

Last updated

2019-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Microflora, Microbiome, skin physiology, Fitzpatrick Skin Types I-III, Tape-stripped wounds

Brief summary

This single center, randomized, 15-day clinical trial is being conducted to assess the changes to the skin microbiome of induced wounds on the back in approximately 35 healthy adult subjects aged 18-55 years, with Fitzpatrick Skin Types I - III. Microbiome and skin physiology assessments will be completed.

Interventions

DEVICEADHESIVE BANDAGE #1

Bandage applied daily to wounded site for 14 days

DEVICEADHESIVE BANDAGE #2

Bandage applied daily to wounded site for 14 days

DEVICEADHESIVE BANDAGE #3

Bandage applied daily to wounded site for 14 days

DEVICEAntibacterial Bandage with 0.8% BZK

bandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days

OTHERIntact and No Bandage

This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.

OTHERWounded and No Bandage

This test site will be wounded but will not be treated with a bandage, serving as the positive control site.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Adults aged 18 to 55 years of age. 2. Fitzpatrick skin types I to III. 3. Must be able to comprehend and follow the requirements of the study 4. Avoid excessive sun exposure 5. Willing to refrain from topical product use on the back for the duration of the study. 6. Subjects must agree not to immerse their bandages in water for the duration of the study. 7. Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control

Exclusion criteria

1. Excessively hairy back, acne, scars and pigmentation or nevi t 2. . Pregnant or Lactating, or planning on becoming pregnant; 3. . Known allergies or sensitivities to anesthetics, adhesive bandages, wound treatment products or tapes; 4. . Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results 5. Participation in any other clinical study within 30 days of Visit 1; 6. . Subjects who have a health condition and/or pre-existing or dormant dermatologic conditions or who have clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections 7. Subjects who report using prescription or OTC medication (oral or topical) that can make skin more sensitive or influence the skin (i.e. antibiotics, hormones, insulin, etc.) 8. Subjects receiving topical and/or inhaled medications that may alter or compromise the bleeding/healing process 9. Individuals with a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications and/or radiation 10. . Subjects with a known history of keloid or hypertrophic scar formation; 11. Subjects diagnosed with any blood clotting disorder; 12. Hyperthyroidism or hypothyroidism or with active or recently treated (within 1 year) skin cancer, or those in poor nutritional status; 13 Subjects taking oral Vitamin A derivatives such as Accutane, isotretinon, or using retinoic acid in the past 1 year or using topical Vitamin A derivatives in the 3 weeks prior to study start; 14\. Subjects with clinically infected skin lesions; 15. Subjects with cracked or excoriated skin, or other skin problems. 16. Diabetes mellitus that cannot be controlled by diet alone (i.e. requires systemic medications for control); 17. Subjects with friable skin, at the discretion of the Investigator;

Design outcomes

Primary

Measure	Time frame	Description
Microbial Community Evenness - Day 14	Day 14	Swabs will be collected on the back at Day 14 for analysis based on the Pielou's Evenness Index.
Microbial Community Richness - (Day 14)	Day 14	Swabs 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.
Microbial Community Diversity - Baseline (Day 0)	Baseline (Day 0)	Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Shannon Index.
Microbial Community Diversity - Day 1	Day 1	Swabs will be collected on the back at Day 1 for analysis based on the Shannon Index.
Microbial Community Diversity - Day 2	Day 2	Swabs will be collected on the back at Day 2 for analysis based on the Shannon Index.
Microbial Community Diversity - Day 3	Day 3	Swabs will be collected on the back at Day 3 for analysis based on the Shannon Index.
Microbial Community Diversity - Day 4	Day 4	Swabs will be collected on the back at Day 4 for analysis based on the Shannon Index.
Microbial Community Diversity - Day 5	Day 5	Swabs will be collected on the back at Day 5 for analysis based on the Shannon Index.
Microbial Community Diversity - Day 6	Day 6	Swabs will be collected on the back at Day 6 for analysis based on the Shannon Index.
Microbial Community Diversity - Day 7	Day 7	Swabs will be collected on the back at Day 7 for analysis based on the Shannon Index.
Microbial Community Diversity - Day 14	Day 14	Swabs will be collected on the back at Day 14 for analysis based on the Shannon Index.
Microbial Community Evenness - Baseline (Day 0)	Day 0	Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Pielou's Evenness Index.
Microbial Community Evenness - Day 1	Day 1	Swabs will be collected on the back at Day 1 for analysis based on the Pielou's Evenness Index.
Microbial Community Evenness - Day 2	Day 2	Swabs will be collected on the back at Day 2 for analysis based on the Pielou's Evenness Index.
Microbial Community Evenness - Day 3	Day 3	Swabs will be collected on the back at Day 3 for analysis based on the Pielou's Evenness Index.
Microbial Community Evenness - Day 4	Day 4	Swabs will be collected on the back at Day 4 for analysis based on the Pielou's Evenness Index.
Microbial Community Evenness - Day 5	Day 5	Swabs will be collected on the back at Day 5 for analysis based on the Pielou's Evenness Index.
Microbial Community Evenness - Day 6	Day 6	Swabs will be collected on the back at Day 6 for analysis based on the Pielou's Evenness Index.
Microbial Community Evenness - Day 7	Day 7	Swabs will be collected on the back at Day 7 for analysis based on the Pielou's Evenness Index.
Microbial Community Richness - Baseline (Day 0)	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.
Microbial Community Richness - (Day 1)	Day 1	Swabs 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.
Microbial Community Richness - (Day 2)	Day 2	Swabs 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.
Microbial Community Richness - (Day 3)	Day 3	Swabs 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.
Microbial Community Richness - (Day 4)	Day 4	Swabs 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.
Microbial Community Richness - (Day 5)	Day 5	Swabs 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.
Microbial Community Richness - (Day 6)	Day 6	Swabs 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.
Microbial Community Richness - (Day 7)	Day 7	Swabs 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.

Secondary

Measure	Time frame	Description
Skin Barrier Function - Day 1	Day 1	The skin barrier function of the test sites will be evaluated at Day 1 by Trans Epidermal Water Loss (TEWL).
Skin Barrier Function - Day 2	Day 2	The skin barrier function of the test sites will be evaluated at Day 2 by Trans Epidermal Water Loss (TEWL).
Skin Barrier Function - Day 3	Day 3	The skin barrier function of the test sites will be evaluated at Day 3 by Trans Epidermal Water Loss (TEWL).
Skin Barrier Function - Day 4	Day 4	The skin barrier function of the test sites will be evaluated at Day 4 by Trans Epidermal Water Loss (TEWL).
Skin Barrier Function - Day 5	Day 5	The skin barrier function of the test sites will be evaluated at Day 5 by Trans Epidermal Water Loss (TEWL).
Skin Barrier Function - Day 6	Day 6	The skin barrier function of the test sites will be evaluated at Day 6 by Trans Epidermal Water Loss (TEWL).
Skin Barrier Function - Day 7	Day 7	The skin barrier function of the test sites will be evaluated at Day 7 by Trans Epidermal Water Loss (TEWL).
Skin Barrier Function - Day 14	Day 14	The skin barrier function of the test sites will be evaluated at Day 14 by Trans Epidermal Water Loss (TEWL).
Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)	Day 0	Quantification 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.
Redness: Wound Area Oxyhemoglobin Level - Day 1	Day 1	Quantification 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.
Redness: Wound Area Oxyhemoglobin Level - Day 2	Day 2	Quantification 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.
Redness: Wound Area Oxyhemoglobin Level - Day 3	Day 3	Quantification 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.
Redness: Wound Area Oxyhemoglobin Level - Day 4	Day 4	Quantification 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.
Redness: Wound Area Oxyhemoglobin Level - Day 5	Day 5	Quantification 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.
Redness: Wound Area Oxyhemoglobin Level - Day 6	Day 6	Quantification 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.
Redness: Wound Area Oxyhemoglobin Level - Day 7	Day 7	Quantification 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.
Redness: Wound Area Oxyhemoglobin Level - Day 14	Day 14	Quantification 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.
Skin Barrier Function -Baseline (Day 0)	Day 0	The skin barrier function of the test sites will be evaluated at Baseline (Day 0) by Trans Epidermal Water Loss (TEWL).

Countries

United States

Participant flow

Participants by arm

Arm	Count
All Randomized Subjects All Randomized Subjects	35
Total	35

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	All Randomized Subjects
Age, Continuous	42.5 years STANDARD_DEVIATION 12.05
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	35 Participants
Region of Enrollment North America USA	35 Participants
Sex: Female, Male Female	25 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 35
other Total, other adverse events	0 / 35
serious Total, serious adverse events	0 / 35

Outcome results

Primary

Microbial Community Diversity - Baseline (Day 0)

Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Shannon Index.

Time frame: Baseline (Day 0)

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Diversity - Baseline (Day 0)	1.702946961 Shannon Diversity Index
Wounded Uncovered Skin	Microbial Community Diversity - Baseline (Day 0)	0.938913363 Shannon Diversity Index
Product #1	Microbial Community Diversity - Baseline (Day 0)	1.470084856 Shannon Diversity Index
Product #2	Microbial Community Diversity - Baseline (Day 0)	1.16250018 Shannon Diversity Index
Product #3	Microbial Community Diversity - Baseline (Day 0)	1.355575793 Shannon Diversity Index
Product #4	Microbial Community Diversity - Baseline (Day 0)	1.278886018 Shannon Diversity Index

p-value: 0.193667t-test, 2 sided

p-value: 0.526573t-test, 2 sided

p-value: 0.898749t-test, 2 sided

p-value: 0.975044t-test, 2 sided

p-value: 0.760706t-test, 2 sided

p-value: 0.985237t-test, 2 sided

p-value: 0.837995t-test, 2 sided

p-value: 0.592697t-test, 2 sided

p-value: 0.912495t-test, 2 sided

p-value: 0.99245t-test, 2 sided

p-value: 0.925553t-test, 2 sided

p-value: 0.999171t-test, 2 sided

p-value: 0.999324t-test, 2 sided

p-value: 0.999913t-test, 2 sided

p-value: 0.990516t-test, 2 sided

Primary

Microbial Community Diversity - Day 1

Swabs will be collected on the back at Day 1 for analysis based on the Shannon Index.

Time frame: Day 1

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Diversity - Day 1	1.703357647 Shannon Diversity Index
Wounded Uncovered Skin	Microbial Community Diversity - Day 1	1.45014401 Shannon Diversity Index
Product #1	Microbial Community Diversity - Day 1	0.786918525 Shannon Diversity Index
Product #2	Microbial Community Diversity - Day 1	1.518890457 Shannon Diversity Index
Product #3	Microbial Community Diversity - Day 1	1.060560749 Shannon Diversity Index
Product #4	Microbial Community Diversity - Day 1	0.900390717 Shannon Diversity Index

p-value: 0.92106t-test, 2 sided

p-value: 0.976812t-test, 2 sided

p-value: 0.233992t-test, 2 sided

p-value: 0.007591t-test, 2 sided

p-value: 0.038958t-test, 2 sided

p-value: 0.99809t-test, 2 sided

p-value: 0.773028t-test, 2 sided

p-value: 0.135805t-test, 2 sided

p-value: 0.350556t-test, 2 sided

p-value: 0.61046t-test, 2 sided

p-value: 0.062163t-test, 2 sided

p-value: 0.203418t-test, 2 sided

p-value: 0.942304t-test, 2 sided

p-value: 0.995238t-test, 2 sided

p-value: 0.99858t-test, 2 sided

Primary

Microbial Community Diversity - Day 14

Swabs will be collected on the back at Day 14 for analysis based on the Shannon Index.

Time frame: Day 14

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Diversity - Day 14	1.992920174 Shannon Diversity Index
Wounded Uncovered Skin	Microbial Community Diversity - Day 14	1.729295419 Shannon Diversity Index
Product #1	Microbial Community Diversity - Day 14	0.826824832 Shannon Diversity Index
Product #2	Microbial Community Diversity - Day 14	1.188271444 Shannon Diversity Index
Product #3	Microbial Community Diversity - Day 14	1.362870394 Shannon Diversity Index
Product #4	Microbial Community Diversity - Day 14	0.729090928 Shannon Diversity Index

p-value: 0.862516t-test, 2 sided

p-value: 0.00473t-test, 2 sided

p-value: 0.085238t-test, 2 sided

p-value: <0.001t-test, 2 sided

p-value: 0.168409t-test, 2 sided

p-value: 0.652654t-test, 2 sided

p-value: 0.001436t-test, 2 sided

p-value: 0.000235t-test, 2 sided

p-value: 0.974842t-test, 2 sided

p-value: 0.557877t-test, 2 sided

p-value: 0.277244t-test, 2 sided

p-value: 0.195527t-test, 2 sided

p-value: 0.070843t-test, 2 sided

p-value: 0.997565t-test, 2 sided

Primary

Microbial Community Diversity - Day 2

Swabs will be collected on the back at Day 2 for analysis based on the Shannon Index.

Time frame: Day 2

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Diversity - Day 2	1.776794637 Shannon Diversity Index
Wounded Uncovered Skin	Microbial Community Diversity - Day 2	1.866171013 Shannon Diversity Index
Product #1	Microbial Community Diversity - Day 2	0.793586986 Shannon Diversity Index
Product #2	Microbial Community Diversity - Day 2	1.169519236 Shannon Diversity Index
Product #3	Microbial Community Diversity - Day 2	1.327096148 Shannon Diversity Index
Product #4	Microbial Community Diversity - Day 2	0.941432164 Shannon Diversity Index

p-value: 0.998949t-test, 2 sided

p-value: 0.111084t-test, 2 sided

p-value: 0.456846t-test, 2 sided

p-value: 0.00062t-test, 2 sided

p-value: 0.006871t-test, 2 sided

p-value: 0.039407t-test, 2 sided

p-value: 0.245375t-test, 2 sided

p-value: 0.000113t-test, 2 sided

p-value: 0.001612t-test, 2 sided

p-value: 0.988067t-test, 2 sided

p-value: 0.599171t-test, 2 sided

p-value: 0.928722t-test, 2 sided

p-value: 0.256079t-test, 2 sided

p-value: 0.626498t-test, 2 sided

p-value: 0.988693t-test, 2 sided

Primary

Microbial Community Diversity - Day 3

Swabs will be collected on the back at Day 3 for analysis based on the Shannon Index.

Time frame: Day 3

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Diversity - Day 3	1.85115546 Shannon Diversity Index
Wounded Uncovered Skin	Microbial Community Diversity - Day 3	1.765408531 Shannon Diversity Index
Product #1	Microbial Community Diversity - Day 3	0.7122095 Shannon Diversity Index
Product #2	Microbial Community Diversity - Day 3	1.046670711 Shannon Diversity Index
Product #3	Microbial Community Diversity - Day 3	1.322070974 Shannon Diversity Index
Product #4	Microbial Community Diversity - Day 3	1.071628134 Shannon Diversity Index

p-value: 0.99916t-test, 2 sided

p-value: 0.016246t-test, 2 sided

p-value: 0.289112t-test, 2 sided

p-value: 0.000038t-test, 2 sided

p-value: 0.014558t-test, 2 sided

p-value: 0.03731t-test, 2 sided

p-value: 0.465745t-test, 2 sided

p-value: 0.000112t-test, 2 sided

p-value: 0.034575t-test, 2 sided

p-value: 0.889597t-test, 2 sided

p-value: 0.726932t-test, 2 sided

p-value: 0.999998t-test, 2 sided

p-value: 0.130235t-test, 2 sided

p-value: 0.910989t-test, 2 sided

p-value: 0.616933t-test, 2 sided

Primary

Microbial Community Diversity - Day 4

Swabs will be collected on the back at Day 4 for analysis based on the Shannon Index.

Time frame: Day 4

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Diversity - Day 4	1.932633093 Shannon Diversity Index
Wounded Uncovered Skin	Microbial Community Diversity - Day 4	1.88044173 Shannon Diversity Index
Product #1	Microbial Community Diversity - Day 4	0.797557627 Shannon Diversity Index
Product #2	Microbial Community Diversity - Day 4	1.453888326 Shannon Diversity Index
Product #3	Microbial Community Diversity - Day 4	1.513528952 Shannon Diversity Index
Product #4	Microbial Community Diversity - Day 4	0.76492761 Shannon Diversity Index

p-value: 0.999952t-test, 2 sided

p-value: 0.421347t-test, 2 sided

p-value: 0.598141t-test, 2 sided

p-value: 0.000197t-test, 2 sided

p-value: 0.000115t-test, 2 sided

p-value: 0.511155t-test, 2 sided

p-value: 0.693868t-test, 2 sided

p-value: 0.000232t-test, 2 sided

p-value: 0.000133t-test, 2 sided

p-value: 0.999894t-test, 2 sided

p-value: 0.078046t-test, 2 sided

p-value: 0.054975t-test, 2 sided

p-value: 0.050132t-test, 2 sided

p-value: 0.034793t-test, 2 sided

p-value: 0.999993t-test, 2 sided

Primary

Microbial Community Diversity - Day 5

Swabs will be collected on the back at Day 5 for analysis based on the Shannon Index.

Time frame: Day 5

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Diversity - Day 5	1.783329786 Shannon Diversity Index
Wounded Uncovered Skin	Microbial Community Diversity - Day 5	1.664197367 Shannon Diversity Index
Product #1	Microbial Community Diversity - Day 5	0.700642641 Shannon Diversity Index
Product #2	Microbial Community Diversity - Day 5	1.267584901 Shannon Diversity Index
Product #3	Microbial Community Diversity - Day 5	1.480613855 Shannon Diversity Index
Product #4	Microbial Community Diversity - Day 5	0.68710958 Shannon Diversity Index

p-value: 0.997406t-test, 2 sided

p-value: 0.354187t-test, 2 sided

p-value: 0.883222t-test, 2 sided

p-value: 0.000412t-test, 2 sided

p-value: 0.000332t-test, 2 sided

p-value: 0.626878t-test, 2 sided

p-value: 0.984465t-test, 2 sided

p-value: 0.001845t-test, 2 sided

p-value: 0.001507t-test, 2 sided

p-value: 0.970029t-test, 2 sided

p-value: 0.19886t-test, 2 sided

p-value: 0.177549t-test, 2 sided

p-value: 0.041698t-test, 2 sided

p-value: 0.036131t-test, 2 sided

p-value: 1t-test, 2 sided

Primary

Microbial Community Diversity - Day 6

Swabs will be collected on the back at Day 6 for analysis based on the Shannon Index.

Time frame: Day 6

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Diversity - Day 6	1.782776526 Shannon Diversity Index
Wounded Uncovered Skin	Microbial Community Diversity - Day 6	1.799754753 Shannon Diversity Index
Product #1	Microbial Community Diversity - Day 6	0.865721173 Shannon Diversity Index
Product #2	Microbial Community Diversity - Day 6	1.223240388 Shannon Diversity Index
Product #3	Microbial Community Diversity - Day 6	1.425318411 Shannon Diversity Index
Product #4	Microbial Community Diversity - Day 6	0.698409234 Shannon Diversity Index

p-value: 1t-test, 2 sided

p-value: 0.317315t-test, 2 sided

p-value: 0.829352t-test, 2 sided

p-value: 0.010561t-test, 2 sided

p-value: 0.001099t-test, 2 sided

p-value: 0.175148t-test, 2 sided

p-value: 0.728796t-test, 2 sided

p-value: 0.001992t-test, 2 sided

p-value: 0.000113t-test, 2 sided

p-value: 0.974567t-test, 2 sided

p-value: 0.668933t-test, 2 sided

p-value: 0.239446t-test, 2 sided

p-value: 0.283848t-test, 2 sided

p-value: 0.06829t-test, 2 sided

p-value: 0.979516t-test, 2 sided

Primary

Microbial Community Diversity - Day 7

Swabs will be collected on the back at Day 7 for analysis based on the Shannon Index.

Time frame: Day 7

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Diversity - Day 7	1.637800497 Shannon Diversity Index
Wounded Uncovered Skin	Microbial Community Diversity - Day 7	1.765588383 Shannon Diversity Index
Product #1	Microbial Community Diversity - Day 7	0.848189016 Shannon Diversity Index
Product #2	Microbial Community Diversity - Day 7	1.328769036 Shannon Diversity Index
Product #3	Microbial Community Diversity - Day 7	1.367835908 Shannon Diversity Index
Product #4	Microbial Community Diversity - Day 7	0.791935871 Shannon Diversity Index

p-value: 0.996522t-test, 2 sided

p-value: 0.875832t-test, 2 sided

p-value: 0.938t-test, 2 sided

p-value: 0.038527t-test, 2 sided

p-value: 0.018334t-test, 2 sided

p-value: 0.512209t-test, 2 sided

p-value: 0.665529t-test, 2 sided

p-value: 0.002257t-test, 2 sided

p-value: 0.000728t-test, 2 sided

p-value: 0.999993t-test, 2 sided

p-value: 0.417914t-test, 2 sided

p-value: 0.277469t-test, 2 sided

p-value: 0.385419t-test, 2 sided

p-value: 0.257647t-test, 2 sided

p-value: 0.999897t-test, 2 sided

Primary

Microbial Community Evenness - Baseline (Day 0)

Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Pielou's Evenness Index.

Time frame: Day 0

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Evenness - Baseline (Day 0)	0.410155753 Pielou's Evenness Index
Wounded Uncovered Skin	Microbial Community Evenness - Baseline (Day 0)	0.271955307 Pielou's Evenness Index
Product #1	Microbial Community Evenness - Baseline (Day 0)	0.402950073 Pielou's Evenness Index
Product #2	Microbial Community Evenness - Baseline (Day 0)	0.320061269 Pielou's Evenness Index
Product #3	Microbial Community Evenness - Baseline (Day 0)	0.358334602 Pielou's Evenness Index
Product #4	Microbial Community Evenness - Baseline (Day 0)	0.325047059 Pielou's Evenness Index

p-value: 0.016628t-test, 2 sided

p-value: 0.217862t-test, 2 sided

p-value: 0.812915t-test, 2 sided

p-value: 0.999971t-test, 2 sided

p-value: 0.275557t-test, 2 sided

p-value: 0.870124t-test, 2 sided

p-value: 0.380144t-test, 2 sided

p-value: 0.029518t-test, 2 sided

p-value: 0.815476t-test, 2 sided

p-value: 0.944307t-test, 2 sided

p-value: 0.313389t-test, 2 sided

p-value: 0.999996t-test, 2 sided

p-value: 0.894272t-test, 2 sided

p-value: 0.969093t-test, 2 sided

p-value: 0.383434t-test, 2 sided

Primary

Microbial Community Evenness - Day 1

Swabs will be collected on the back at Day 1 for analysis based on the Pielou's Evenness Index.

Time frame: Day 1

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Evenness - Day 1	0.437132278 Pielou's Evenness Index
Wounded Uncovered Skin	Microbial Community Evenness - Day 1	0.349459879 Pielou's Evenness Index
Product #1	Microbial Community Evenness - Day 1	0.246062404 Pielou's Evenness Index
Product #2	Microbial Community Evenness - Day 1	0.389333736 Pielou's Evenness Index
Product #3	Microbial Community Evenness - Day 1	0.273028286 Pielou's Evenness Index
Product #4	Microbial Community Evenness - Day 1	0.265726584 Pielou's Evenness Index

p-value: 0.393119t-test, 2 sided

p-value: 0.890335t-test, 2 sided

p-value: 0.021978t-test, 2 sided

p-value: 0.000983t-test, 2 sided

p-value: 0.006615t-test, 2 sided

p-value: 0.951883t-test, 2 sided

p-value: 0.692455t-test, 2 sided

p-value: 0.257254t-test, 2 sided

p-value: 0.530181t-test, 2 sided

p-value: 0.219274t-test, 2 sided

p-value: 0.029675t-test, 2 sided

p-value: 0.111454t-test, 2 sided

p-value: 0.995849t-test, 2 sided

p-value: 0.999994t-test, 2 sided

p-value: 0.998744t-test, 2 sided

Primary

Microbial Community Evenness - Day 14

Swabs will be collected on the back at Day 14 for analysis based on the Pielou's Evenness Index.

Time frame: Day 14

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Evenness - Day 14	0.454253238 Pielou's Evenness Index
Wounded Uncovered Skin	Microbial Community Evenness - Day 14	0.402829439 Pielou's Evenness Index
Product #1	Microbial Community Evenness - Day 14	0.249502521 Pielou's Evenness Index
Product #2	Microbial Community Evenness - Day 14	0.308795465 Pielou's Evenness Index
Product #3	Microbial Community Evenness - Day 14	0.383110745 Pielou's Evenness Index
Product #4	Microbial Community Evenness - Day 14	0.210741952 Pielou's Evenness Index

p-value: 0.891244t-test, 2 sided

p-value: 0.022659t-test, 2 sided

p-value: 0.693615t-test, 2 sided

p-value: 0.000237t-test, 2 sided

p-value: 0.000005t-test, 2 sided

p-value: 0.352008t-test, 2 sided

p-value: 0.998761t-test, 2 sided

p-value: 0.017832t-test, 2 sided

p-value: 0.000974t-test, 2 sided

p-value: 0.638238t-test, 2 sided

p-value: 0.777423t-test, 2 sided

p-value: 0.249909t-test, 2 sided

p-value: 0.068196t-test, 2 sided

p-value: 0.005786t-test, 2 sided

p-value: 0.954163t-test, 2 sided

Primary

Microbial Community Evenness - Day 2

Swabs will be collected on the back at Day 2 for analysis based on the Pielou's Evenness Index.

Time frame: Day 2

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Evenness - Day 2	0.42693493 Pielou's Evenness Index
Wounded Uncovered Skin	Microbial Community Evenness - Day 2	0.415386732 Pielou's Evenness Index
Product #1	Microbial Community Evenness - Day 2	0.263575452 Pielou's Evenness Index
Product #2	Microbial Community Evenness - Day 2	0.322568391 Pielou's Evenness Index
Product #3	Microbial Community Evenness - Day 2	0.386309873 Pielou's Evenness Index
Product #4	Microbial Community Evenness - Day 2	0.277342605 Pielou's Evenness Index

p-value: 0.999858t-test, 2 sided

p-value: 0.215132t-test, 2 sided

p-value: 0.958812t-test, 2 sided

p-value: 0.00622t-test, 2 sided

p-value: 0.017733t-test, 2 sided

p-value: 0.330576t-test, 2 sided

p-value: 0.990334t-test, 2 sided

p-value: 0.013025t-test, 2 sided

p-value: 0.034707t-test, 2 sided

p-value: 0.771698t-test, 2 sided

p-value: 0.790117t-test, 2 sided

p-value: 0.923224t-test, 2 sided

p-value: 0.112245t-test, 2 sided

p-value: 0.216229t-test, 2 sided

p-value: 0.999663t-test, 2 sided

Primary

Microbial Community Evenness - Day 3

Swabs will be collected on the back at Day 3 for analysis based on the Pielou's Evenness Index.

Time frame: Day 3

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Evenness - Day 3	0.455666826 Pielou's Evenness Index
Wounded Uncovered Skin	Microbial Community Evenness - Day 3	0.405262792 Pielou's Evenness Index
Product #1	Microbial Community Evenness - Day 3	0.234966957 Pielou's Evenness Index
Product #2	Microbial Community Evenness - Day 3	0.279414327 Pielou's Evenness Index
Product #3	Microbial Community Evenness - Day 3	0.363143499 Pielou's Evenness Index
Product #4	Microbial Community Evenness - Day 3	0.312661752 Pielou's Evenness Index

p-value: 0.91874t-test, 2 sided

p-value: 0.013582t-test, 2 sided

p-value: 0.523284t-test, 2 sided

p-value: 0.000315t-test, 2 sided

p-value: 0.059485t-test, 2 sided

p-value: 0.15037t-test, 2 sided

p-value: 0.967277t-test, 2 sided

p-value: 0.008729t-test, 2 sided

p-value: 0.421603t-test, 2 sided

p-value: 0.647267t-test, 2 sided

p-value: 0.953645t-test, 2 sided

p-value: 0.987387t-test, 2 sided

p-value: 0.147361t-test, 2 sided

p-value: 0.930371t-test, 2 sided

p-value: 0.6094t-test, 2 sided

Primary

Microbial Community Evenness - Day 4

Swabs will be collected on the back at Day 4 for analysis based on the Pielou's Evenness Index.

Time frame: Day 4

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Evenness - Day 4	0.451377803 Pielou's Evenness Index
Wounded Uncovered Skin	Microbial Community Evenness - Day 4	0.422737764 Pielou's Evenness Index
Product #1	Microbial Community Evenness - Day 4	0.269049335 Pielou's Evenness Index
Product #2	Microbial Community Evenness - Day 4	0.38804873 Pielou's Evenness Index
Product #3	Microbial Community Evenness - Day 4	0.392633921 Pielou's Evenness Index
Product #4	Microbial Community Evenness - Day 4	0.231556861 Pielou's Evenness Index

p-value: 0.99253t-test, 2 sided

p-value: 0.795279t-test, 2 sided

p-value: 0.855067t-test, 2 sided

p-value: 0.003915t-test, 2 sided

p-value: 0.000221t-test, 2 sided

p-value: 0.97816t-test, 2 sided

p-value: 0.98972t-test, 2 sided

p-value: 0.01764t-test, 2 sided

p-value: 0.001185t-test, 2 sided

p-value: 0.999999t-test, 2 sided

p-value: 0.119961t-test, 2 sided

p-value: 0.013468t-test, 2 sided

p-value: 0.112192t-test, 2 sided

p-value: 0.013135t-test, 2 sided

p-value: 0.965966t-test, 2 sided

Primary

Microbial Community Evenness - Day 5

Swabs will be collected on the back at Day 5 for analysis based on the Pielou's Evenness Index.

Time frame: Day 5

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Evenness - Day 5	0.418779366 Pielou's Evenness Index
Wounded Uncovered Skin	Microbial Community Evenness - Day 5	0.377673266 Pielou's Evenness Index
Product #1	Microbial Community Evenness - Day 5	0.235666776 Pielou's Evenness Index
Product #2	Microbial Community Evenness - Day 5	0.330181203 Pielou's Evenness Index
Product #3	Microbial Community Evenness - Day 5	0.388971323 Pielou's Evenness Index
Product #4	Microbial Community Evenness - Day 5	0.212340111 Pielou's Evenness Index

p-value: 0.968005t-test, 2 sided

p-value: 0.526293t-test, 2 sided

p-value: 0.994384t-test, 2 sided

p-value: 0.004967t-test, 2 sided

p-value: 0.000948t-test, 2 sided

p-value: 0.936394t-test, 2 sided

p-value: 0.999945t-test, 2 sided

p-value: 0.050032t-test, 2 sided

p-value: 0.01256t-test, 2 sided

p-value: 0.886978t-test, 2 sided

p-value: 0.391295t-test, 2 sided

p-value: 0.163678t-test, 2 sided

p-value: 0.047937t-test, 2 sided

p-value: 0.013231t-test, 2 sided

p-value: 0.996358t-test, 2 sided

Primary

Microbial Community Evenness - Day 6

Swabs will be collected on the back at Day 6 for analysis based on the Pielou's Evenness Index.

Time frame: Day 6

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Evenness - Day 6	0.446298915 Pielou's Evenness Index
Wounded Uncovered Skin	Microbial Community Evenness - Day 6	0.417003638 Pielou's Evenness Index
Product #1	Microbial Community Evenness - Day 6	0.270297461 Pielou's Evenness Index
Product #2	Microbial Community Evenness - Day 6	0.31595456 Pielou's Evenness Index
Product #3	Microbial Community Evenness - Day 6	0.370960196 Pielou's Evenness Index
Product #4	Microbial Community Evenness - Day 6	0.213078749 Pielou's Evenness Index

p-value: 0.995862t-test, 2 sided

p-value: 0.223341t-test, 2 sided

p-value: 0.834338t-test, 2 sided

p-value: 0.030267t-test, 2 sided

p-value: 0.00104t-test, 2 sided

p-value: 0.377217t-test, 2 sided

p-value: 0.965547t-test, 2 sided

p-value: 0.052284t-test, 2 sided

p-value: 0.001348t-test, 2 sided

p-value: 0.927936t-test, 2 sided

p-value: 0.946487t-test, 2 sided

p-value: 0.327918t-test, 2 sided

p-value: 0.475038t-test, 2 sided

p-value: 0.060057t-test, 2 sided

p-value: 0.857177t-test, 2 sided

Primary

Microbial Community Evenness - Day 7

Swabs will be collected on the back at Day 7 for analysis based on the Pielou's Evenness Index.

Time frame: Day 7

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Evenness - Day 7	0.410567291 Pielou's Evenness Index
Wounded Uncovered Skin	Microbial Community Evenness - Day 7	0.404030653 Pielou's Evenness Index
Product #1	Microbial Community Evenness - Day 7	0.247507869 Pielou's Evenness Index
Product #2	Microbial Community Evenness - Day 7	0.354717133 Pielou's Evenness Index
Product #3	Microbial Community Evenness - Day 7	0.359914043 Pielou's Evenness Index
Product #4	Microbial Community Evenness - Day 7	0.230659131 Pielou's Evenness Index

p-value: 0.999997t-test, 2 sided

p-value: 0.938793t-test, 2 sided

p-value: 0.965993t-test, 2 sided

p-value: 0.057803t-test, 2 sided

p-value: 0.022816t-test, 2 sided

p-value: 0.945179t-test, 2 sided

p-value: 0.972522t-test, 2 sided

p-value: 0.033704t-test, 2 sided

p-value: 0.010747t-test, 2 sided

p-value: 0.999999t-test, 2 sided

p-value: 0.385474t-test, 2 sided

p-value: 0.213798t-test, 2 sided

p-value: 0.388682t-test, 2 sided

p-value: 0.22386t-test, 2 sided

p-value: 0.999494t-test, 2 sided

Primary

Microbial Community Richness - 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.

Time frame: Baseline (Day 0)

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Richness - Baseline (Day 0)	56.5862069 Number of bacterial taxa
Wounded Uncovered Skin	Microbial Community Richness - Baseline (Day 0)	32.13043478 Number of bacterial taxa
Product #1	Microbial Community Richness - Baseline (Day 0)	43.72413793 Number of bacterial taxa
Product #2	Microbial Community Richness - Baseline (Day 0)	34.03703704 Number of bacterial taxa
Product #3	Microbial Community Richness - Baseline (Day 0)	42.39130435 Number of bacterial taxa
Product #4	Microbial Community Richness - Baseline (Day 0)	46.48148148 Number of bacterial taxa

p-value: 0.071225t-test, 2 sided

p-value: 0.092027t-test, 2 sided

p-value: 0.601716t-test, 2 sided

p-value: 0.639911t-test, 2 sided

p-value: 0.842476t-test, 2 sided

p-value: 0.999941t-test, 2 sided

p-value: 0.883479t-test, 2 sided

p-value: 0.782208t-test, 2 sided

p-value: 0.607134t-test, 2 sided

p-value: 0.939549t-test, 2 sided

p-value: 0.86475t-test, 2 sided

p-value: 0.704759t-test, 2 sided

p-value: 0.999989t-test, 2 sided

p-value: 0.997568t-test, 2 sided

p-value: 0.999518t-test, 2 sided

Primary

Microbial Community Richness - (Day 1)

Swabs 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.

Time frame: Day 1

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Richness - (Day 1)	53.15625 Number of bacterial taxa
Wounded Uncovered Skin	Microbial Community Richness - (Day 1)	58.75862069 Number of bacterial taxa
Product #1	Microbial Community Richness - (Day 1)	22 Number of bacterial taxa
Product #2	Microbial Community Richness - (Day 1)	53.5 Number of bacterial taxa
Product #3	Microbial Community Richness - (Day 1)	42.47368421 Number of bacterial taxa
Product #4	Microbial Community Richness - (Day 1)	28.83333333 Number of bacterial taxa

p-value: 0.985332t-test, 2 sided

p-value: 1t-test, 2 sided

p-value: 0.870459t-test, 2 sided

p-value: 0.004963t-test, 2 sided

p-value: 0.071935t-test, 2 sided

p-value: 0.988995t-test, 2 sided

p-value: 0.545378t-test, 2 sided

p-value: 0.000649t-test, 2 sided

p-value: 0.0146t-test, 2 sided

p-value: 0.854566t-test, 2 sided

p-value: 0.004322t-test, 2 sided

p-value: 0.0651t-test, 2 sided

p-value: 0.300536t-test, 2 sided

p-value: 0.753883t-test, 2 sided

p-value: 0.97621t-test, 2 sided

Primary

Microbial Community Richness - (Day 14)

Swabs 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.

Time frame: Day 14

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Richness - (Day 14)	73.1 Number of bacterial taxa
Wounded Uncovered Skin	Microbial Community Richness - (Day 14)	66.44444444 Number of bacterial taxa
Product #1	Microbial Community Richness - (Day 14)	28.34375 Number of bacterial taxa
Product #2	Microbial Community Richness - (Day 14)	46.21875 Number of bacterial taxa
Product #3	Microbial Community Richness - (Day 14)	32.32 Number of bacterial taxa
Product #4	Microbial Community Richness - (Day 14)	30.45454545 Number of bacterial taxa

p-value: 0.943522t-test, 2 sided

p-value: 0.002376t-test, 2 sided

p-value: <0.001t-test, 2 sided

p-value: 0.061015t-test, 2 sided

p-value: 0.000211t-test, 2 sided

p-value: <0.001t-test, 2 sided

p-value: 0.412626t-test, 2 sided

p-value: 0.104388t-test, 2 sided

p-value: 0.197791t-test, 2 sided

p-value: 0.994413t-test, 2 sided

p-value: 0.999851t-test, 2 sided

p-value: 0.999621t-test, 2 sided

Primary

Microbial Community Richness - (Day 2)

Swabs 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.

Time frame: Day 2

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Richness - (Day 2)	60.15625 Number of bacterial taxa
Wounded Uncovered Skin	Microbial Community Richness - (Day 2)	87.03030303 Number of bacterial taxa
Product #1	Microbial Community Richness - (Day 2)	20.33333333 Number of bacterial taxa
Product #2	Microbial Community Richness - (Day 2)	36.65625 Number of bacterial taxa
Product #3	Microbial Community Richness - (Day 2)	33.7037037 Number of bacterial taxa
Product #4	Microbial Community Richness - (Day 2)	30.40625 Number of bacterial taxa

p-value: 0.027774t-test, 2 sided

p-value: 0.08431t-test, 2 sided

p-value: 0.049247t-test, 2 sided

p-value: 0.000126t-test, 2 sided

p-value: 0.010829t-test, 2 sided

p-value: <0.001t-test, 2 sided

p-value: 0.999533t-test, 2 sided

p-value: 0.4205363t-test, 2 sided

p-value: 0.9802252t-test, 2 sided

p-value: 0.6845362t-test, 2 sided

p-value: 0.9992002t-test, 2 sided

p-value: 0.8562779t-test, 2 sided

Primary

Microbial Community Richness - (Day 3)

Swabs 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.

Time frame: Day 3

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Richness - (Day 3)	53.44827586 Number of bacterial taxa
Wounded Uncovered Skin	Microbial Community Richness - (Day 3)	74.03125 Number of bacterial taxa
Product #1	Microbial Community Richness - (Day 3)	19.21212121 Number of bacterial taxa
Product #2	Microbial Community Richness - (Day 3)	38.25925926 Number of bacterial taxa
Product #3	Microbial Community Richness - (Day 3)	37.88 Number of bacterial taxa
Product #4	Microbial Community Richness - (Day 3)	30.28125 Number of bacterial taxa

p-value: 0.0403539t-test, 2 sided

p-value: 0.2953049t-test, 2 sided

p-value: 0.290551t-test, 2 sided

p-value: 0.0000247t-test, 2 sided

p-value: 0.0133001t-test, 2 sided

p-value: 0.0000167t-test, 2 sided

p-value: 0.0000212t-test, 2 sided

p-value: <0.001t-test, 2 sided

p-value: 0.99999995t-test, 2 sided

p-value: 0.0792013t-test, 2 sided

p-value: 0.870163t-test, 2 sided

p-value: 0.103828t-test, 2 sided

p-value: 0.900265t-test, 2 sided

p-value: 0.570015t-test, 2 sided

Primary

Microbial Community Richness - (Day 4)

Swabs 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.

Time frame: Day 4

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Richness - (Day 4)	66.88461538 Number of bacterial taxa
Wounded Uncovered Skin	Microbial Community Richness - (Day 4)	76.23333333 Number of bacterial taxa
Product #1	Microbial Community Richness - (Day 4)	20.5 Number of bacterial taxa
Product #2	Microbial Community Richness - (Day 4)	44.35483871 Number of bacterial taxa
Product #3	Microbial Community Richness - (Day 4)	43.53571429 Number of bacterial taxa
Product #4	Microbial Community Richness - (Day 4)	25.59375 Number of bacterial taxa

p-value: 0.882449t-test, 2 sided

p-value: 0.088558t-test, 2 sided

p-value: 0.081846t-test, 2 sided

p-value: <0.001t-test, 2 sided

p-value: 0.0000303t-test, 2 sided

p-value: 0.001817t-test, 2 sided

p-value: 0.001825t-test, 2 sided

p-value: <0.001t-test, 2 sided

p-value: 0.999999t-test, 2 sided

p-value: 0.038836t-test, 2 sided

p-value: 0.184508t-test, 2 sided

p-value: 0.062829t-test, 2 sided

p-value: 0.253458t-test, 2 sided

p-value: 0.987798t-test, 2 sided

Primary

Microbial Community Richness - (Day 5)

Swabs 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.

Time frame: Day 5

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Richness - (Day 5)	61.96 Number of bacterial taxa
Wounded Uncovered Skin	Microbial Community Richness - (Day 5)	77.59259259 Number of bacterial taxa
Product #1	Microbial Community Richness - (Day 5)	19.03225806 Number of bacterial taxa
Product #2	Microbial Community Richness - (Day 5)	44.03703704 Number of bacterial taxa
Product #3	Microbial Community Richness - (Day 5)	50.33333333 Number of bacterial taxa
Product #4	Microbial Community Richness - (Day 5)	25.80645161 Number of bacterial taxa

p-value: 0.516068t-test, 2 sided

p-value: 0.358412t-test, 2 sided

p-value: 0.834145t-test, 2 sided

p-value: 0.000035t-test, 2 sided

p-value: 0.000843t-test, 2 sided

p-value: 0.002997t-test, 2 sided

p-value: 0.051717t-test, 2 sided

p-value: <0.001t-test, 2 sided

p-value: 0.985602t-test, 2 sided

p-value: 0.046422t-test, 2 sided

p-value: 0.28061t-test, 2 sided

p-value: 0.011015t-test, 2 sided

p-value: 0.089156t-test, 2 sided

p-value: 0.963882t-test, 2 sided

Primary

Microbial Community Richness - (Day 6)

Swabs 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.

Time frame: Day 6

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Richness - (Day 6)	48.5 Number of bacterial taxa
Wounded Uncovered Skin	Microbial Community Richness - (Day 6)	75.88888889 Number of bacterial taxa
Product #1	Microbial Community Richness - (Day 6)	23.55172414 Number of bacterial taxa
Product #2	Microbial Community Richness - (Day 6)	48.81481481 Number of bacterial taxa
Product #3	Microbial Community Richness - (Day 6)	40.26315789 Number of bacterial taxa
Product #4	Microbial Community Richness - (Day 6)	25.63333333 Number of bacterial taxa

p-value: 0.007492t-test, 2 sided

p-value: 0.00526t-test, 2 sided

p-value: 1t-test, 2 sided

p-value: 0.914409t-test, 2 sided

p-value: 0.013004t-test, 2 sided

p-value: 0.028517t-test, 2 sided

p-value: 0.001356t-test, 2 sided

p-value: 0.000059t-test, 2 sided

p-value: <0.001t-test, 2 sided

p-value: 0.859272t-test, 2 sided

p-value: 0.002821t-test, 2 sided

p-value: 0.208803t-test, 2 sided

p-value: 0.341884t-test, 2 sided

p-value: 0.999531t-test, 2 sided

Primary

Microbial Community Richness - (Day 7)

Swabs 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.

Time frame: Day 7

Arm	Measure	Value (MEAN)
Intact Uncovered Skin	Microbial Community Richness - (Day 7)	54.54545455 Number of bacterial taxa
Wounded Uncovered Skin	Microbial Community Richness - (Day 7)	81.51515152 Number of bacterial taxa
Product #1	Microbial Community Richness - (Day 7)	31 Number of bacterial taxa
Product #2	Microbial Community Richness - (Day 7)	45.12 Number of bacterial taxa
Product #3	Microbial Community Richness - (Day 7)	43.04761905 Number of bacterial taxa
Product #4	Microbial Community Richness - (Day 7)	30.57575758 Number of bacterial taxa

p-value: 0.066788t-test, 2 sided

p-value: 0.942653t-test, 2 sided

p-value: 0.893545t-test, 2 sided

p-value: 0.165225t-test, 2 sided

p-value: 0.140475t-test, 2 sided

p-value: 0.002026t-test, 2 sided

p-value: 0.001916t-test, 2 sided

p-value: <0.001t-test, 2 sided

p-value: 0.999957t-test, 2 sided

p-value: 0.672573t-test, 2 sided

p-value: 0.630145t-test, 2 sided

p-value: 0.832757t-test, 2 sided

p-value: 0.803277t-test, 1 sided

p-value: 1t-test, 2 sided

Secondary

Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)

Quantification 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.

Time frame: Day 0

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)	0.82 Arbitrary Unit	Standard Deviation 0.143
Wounded Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)	0.97 Arbitrary Unit	Standard Deviation 0.189
Product #1	Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)	0.96 Arbitrary Unit	Standard Deviation 0.143
Product #2	Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)	1.00 Arbitrary Unit	Standard Deviation 0.198
Product #3	Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)	0.99 Arbitrary Unit	Standard Deviation 0.171
Product #4	Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)	0.98 Arbitrary Unit	Standard Deviation 0.179

Secondary

Redness: Wound Area Oxyhemoglobin Level - Day 1

Time frame: Day 1

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 1	0.83 Arbitrary Unit	Standard Deviation 0.127
Wounded Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 1	1.20 Arbitrary Unit	Standard Deviation 0.17
Product #1	Redness: Wound Area Oxyhemoglobin Level - Day 1	1.15 Arbitrary Unit	Standard Deviation 0.181
Product #2	Redness: Wound Area Oxyhemoglobin Level - Day 1	1.12 Arbitrary Unit	Standard Deviation 0.197
Product #3	Redness: Wound Area Oxyhemoglobin Level - Day 1	1.15 Arbitrary Unit	Standard Deviation 0.178
Product #4	Redness: Wound Area Oxyhemoglobin Level - Day 1	1.22 Arbitrary Unit	Standard Deviation 0.186

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1p-value: 0.34895% CI: [-0.129, 0.0458]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1p-value: 0.01995% CI: [-0.1904, -0.0178]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1p-value: 0.18395% CI: [-0.1437, 0.0278]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1p-value: 0.73695% CI: [-0.0725, 0.1023]ANCOVA

Secondary

Redness: Wound Area Oxyhemoglobin Level - Day 14

Time frame: Day 14

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 14	0.79 Arbitrary Unit	Standard Deviation 0.12
Wounded Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 14	0.90 Arbitrary Unit	Standard Deviation 0.147
Product #1	Redness: Wound Area Oxyhemoglobin Level - Day 14	0.89 Arbitrary Unit	Standard Deviation 0.146
Product #2	Redness: Wound Area Oxyhemoglobin Level - Day 14	0.85 Arbitrary Unit	Standard Deviation 0.125
Product #3	Redness: Wound Area Oxyhemoglobin Level - Day 14	0.84 Arbitrary Unit	Standard Deviation 0.112
Product #4	Redness: Wound Area Oxyhemoglobin Level - Day 14	0.92 Arbitrary Unit	Standard Deviation 0.115

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14p-value: 0.93795% CI: [-0.0818, 0.0755]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14p-value: 0.02695% CI: [-0.1663, -0.0108]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14p-value: 0.04595% CI: [-0.1562, -0.0017]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14p-value: 0.95695% CI: [-0.0799, 0.0755]ANCOVA

Secondary

Redness: Wound Area Oxyhemoglobin Level - Day 2

Time frame: Day 2

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 2	0.85 Arbitrary Unit	Standard Deviation 0.1
Wounded Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 2	1.21 Arbitrary Unit	Standard Deviation 0.166
Product #1	Redness: Wound Area Oxyhemoglobin Level - Day 2	1.16 Arbitrary Unit	Standard Deviation 0.181
Product #2	Redness: Wound Area Oxyhemoglobin Level - Day 2	1.07 Arbitrary Unit	Standard Deviation 0.188
Product #3	Redness: Wound Area Oxyhemoglobin Level - Day 2	1.18 Arbitrary Unit	Standard Deviation 0.218
Product #4	Redness: Wound Area Oxyhemoglobin Level - Day 2	1.37 Arbitrary Unit	Standard Deviation 0.212

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2p-value: 0.51695% CI: [-0.136, 0.0687]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2p-value: 0.00695% CI: [-0.2459, -0.0412]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2p-value: 0.67195% CI: [-0.1235, 0.0798]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2p-value: 0.00495% CI: [0.0504, 0.2578]ANCOVA

Secondary

Redness: Wound Area Oxyhemoglobin Level - Day 3

Time frame: Day 3

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 3	0.81 Arbitrary Unit	Standard Deviation 0.156
Wounded Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 3	1.16 Arbitrary Unit	Standard Deviation 0.211
Product #1	Redness: Wound Area Oxyhemoglobin Level - Day 3	1.08 Arbitrary Unit	Standard Deviation 0.121
Product #2	Redness: Wound Area Oxyhemoglobin Level - Day 3	1.06 Arbitrary Unit	Standard Deviation 0.174
Product #3	Redness: Wound Area Oxyhemoglobin Level - Day 3	1.16 Arbitrary Unit	Standard Deviation 0.16
Product #4	Redness: Wound Area Oxyhemoglobin Level - Day 3	1.33 Arbitrary Unit	Standard Deviation 0.252

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3p-value: 0.29295% CI: [-0.1896, 0.0579]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3p-value: 0.01695% CI: [-0.2773, -0.0297]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3p-value: 0.53895% CI: [-0.1622, 0.0853]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3p-value: 0.06195% CI: [-0.0059, 0.2515]ANCOVA

Secondary

Redness: Wound Area Oxyhemoglobin Level - Day 4

Time frame: Day 4

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 4	0.81 Arbitrary Unit	Standard Deviation 0.138
Wounded Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 4	1.20 Arbitrary Unit	Standard Deviation 0.166
Product #1	Redness: Wound Area Oxyhemoglobin Level - Day 4	0.99 Arbitrary Unit	Standard Deviation 0.217
Product #2	Redness: Wound Area Oxyhemoglobin Level - Day 4	0.99 Arbitrary Unit	Standard Deviation 0.205
Product #3	Redness: Wound Area Oxyhemoglobin Level - Day 4	1.14 Arbitrary Unit	Standard Deviation 0.386
Product #4	Redness: Wound Area Oxyhemoglobin Level - Day 4	1.28 Arbitrary Unit	Standard Deviation 0.252

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4p-value: 0.00195% CI: [-0.3265, -0.0895]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4p-value: <0.00195% CI: [-0.3614, -0.1243]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4p-value: 0.23695% CI: [-0.1899, 0.0471]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4p-value: 0.62795% CI: [-0.0902, 0.1492]ANCOVA

Secondary

Redness: Wound Area Oxyhemoglobin Level - Day 5

Time frame: Day 5

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 5	0.81 Arbitrary Unit	Standard Deviation 0.159
Wounded Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 5	1.14 Arbitrary Unit	Standard Deviation 0.208
Product #1	Redness: Wound Area Oxyhemoglobin Level - Day 5	0.90 Arbitrary Unit	Standard Deviation 0.146
Product #2	Redness: Wound Area Oxyhemoglobin Level - Day 5	0.96 Arbitrary Unit	Standard Deviation 0.178
Product #3	Redness: Wound Area Oxyhemoglobin Level - Day 5	1.00 Arbitrary Unit	Standard Deviation 0.207
Product #4	Redness: Wound Area Oxyhemoglobin Level - Day 5	1.26 Arbitrary Unit	Standard Deviation 0.336

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5p-value: <0.00195% CI: [-0.3331, -0.1305]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5p-value: <0.00195% CI: [-0.3091, -0.1092]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5p-value: 0.00595% CI: [-0.2439, -0.0457]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5p-value: 0.0295% CI: [0.0197, 0.2252]ANCOVA

Secondary

Redness: Wound Area Oxyhemoglobin Level - Day 6

Time frame: Day 6

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 6	0.80 Arbitrary Unit	Standard Deviation 0.124
Wounded Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 6	1.20 Arbitrary Unit	Standard Deviation 0.23
Product #1	Redness: Wound Area Oxyhemoglobin Level - Day 6	0.88 Arbitrary Unit	Standard Deviation 0.146
Product #2	Redness: Wound Area Oxyhemoglobin Level - Day 6	0.95 Arbitrary Unit	Standard Deviation 0.148
Product #3	Redness: Wound Area Oxyhemoglobin Level - Day 6	0.98 Arbitrary Unit	Standard Deviation 0.159
Product #4	Redness: Wound Area Oxyhemoglobin Level - Day 6	1.23 Arbitrary Unit	Standard Deviation 0.326

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6p-value: <0.00195% CI: [-0.4019, -0.2044]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6p-value: <0.00195% CI: [-0.3655, -0.1679]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6p-value: <0.00195% CI: [-0.3338, -0.1377]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6p-value: 0.64695% CI: [-0.0767, 0.1231]ANCOVA

Secondary

Redness: Wound Area Oxyhemoglobin Level - Day 7

Time frame: Day 7

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 7	0.78 Arbitrary Unit	Standard Deviation 0.111
Wounded Uncovered Skin	Redness: Wound Area Oxyhemoglobin Level - Day 7	1.02 Arbitrary Unit	Standard Deviation 0.191
Product #1	Redness: Wound Area Oxyhemoglobin Level - Day 7	0.88 Arbitrary Unit	Standard Deviation 0.164
Product #2	Redness: Wound Area Oxyhemoglobin Level - Day 7	0.89 Arbitrary Unit	Standard Deviation 0.151
Product #3	Redness: Wound Area Oxyhemoglobin Level - Day 7	0.88 Arbitrary Unit	Standard Deviation 0.141
Product #4	Redness: Wound Area Oxyhemoglobin Level - Day 7	1.03 Arbitrary Unit	Standard Deviation 0.279

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7p-value: 0.00695% CI: [-0.2254, -0.0384]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7p-value: 0.00295% CI: [-0.2444, -0.0574]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7p-value: 0.00195% CI: [-0.2541, -0.0682]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7p-value: 0.91195% CI: [-0.0891, 0.0998]ANCOVA

Secondary

Skin Barrier Function -Baseline (Day 0)

The skin barrier function of the test sites will be evaluated at Baseline (Day 0) by Trans Epidermal Water Loss (TEWL).

Time frame: Day 0

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Skin Barrier Function -Baseline (Day 0)	9.82 g/m^2/hr	Standard Deviation 6.725
Wounded Uncovered Skin	Skin Barrier Function -Baseline (Day 0)	96.94 g/m^2/hr	Standard Deviation 11.682
Product #1	Skin Barrier Function -Baseline (Day 0)	101.08 g/m^2/hr	Standard Deviation 9.992
Product #2	Skin Barrier Function -Baseline (Day 0)	97.04 g/m^2/hr	Standard Deviation 13.397
Product #3	Skin Barrier Function -Baseline (Day 0)	101.43 g/m^2/hr	Standard Deviation 11.116
Product #4	Skin Barrier Function -Baseline (Day 0)	98.21 g/m^2/hr	Standard Deviation 13.165

Secondary

Skin Barrier Function - Day 1

The skin barrier function of the test sites will be evaluated at Day 1 by Trans Epidermal Water Loss (TEWL).

Time frame: Day 1

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Skin Barrier Function - Day 1	13.05 g/m^2/hr	Standard Deviation 13.414
Wounded Uncovered Skin	Skin Barrier Function - Day 1	95.68 g/m^2/hr	Standard Deviation 16.393
Product #1	Skin Barrier Function - Day 1	92.40 g/m^2/hr	Standard Deviation 10.886
Product #2	Skin Barrier Function - Day 1	91.13 g/m^2/hr	Standard Deviation 14.689
Product #3	Skin Barrier Function - Day 1	97.91 g/m^2/hr	Standard Deviation 14.527
Product #4	Skin Barrier Function - Day 1	97.61 g/m^2/hr	Standard Deviation 15.42

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1p-value: 0.00995% CI: [-13.1279, -1.8688]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1p-value: 0.07795% CI: [-10.7083, 0.5508]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1p-value: 0.39995% CI: [-8.0399, 3.2192]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1p-value: 0.80295% CI: [-4.9144, 6.3446]ANCOVA

Secondary

Skin Barrier Function - Day 14

The skin barrier function of the test sites will be evaluated at Day 14 by Trans Epidermal Water Loss (TEWL).

Time frame: Day 14

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Skin Barrier Function - Day 14	10.32 g/m^2/hr	Standard Deviation 14.697
Wounded Uncovered Skin	Skin Barrier Function - Day 14	14.58 g/m^2/hr	Standard Deviation 13.016
Product #1	Skin Barrier Function - Day 14	16.66 g/m^2/hr	Standard Deviation 9.356
Product #2	Skin Barrier Function - Day 14	16.10 g/m^2/hr	Standard Deviation 15.442
Product #3	Skin Barrier Function - Day 14	10.07 g/m^2/hr	Standard Deviation 4.165
Product #4	Skin Barrier Function - Day 14	16.45 g/m^2/hr	Standard Deviation 5.432

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14p-value: 0.39795% CI: [-9.1631, 3.6504]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14p-value: 0.80495% CI: [-5.6006, 7.2129]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14p-value: 0.00595% CI: [-15.7231, -2.9096]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14p-value: 0.98595% CI: [-6.3452, 6.4683]ANCOVA

Secondary

Skin Barrier Function - Day 2

The skin barrier function of the test sites will be evaluated at Day 2 by Trans Epidermal Water Loss (TEWL).

Time frame: Day 2

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Skin Barrier Function - Day 2	10.97 g/m^2/hr	Standard Deviation 7.527
Wounded Uncovered Skin	Skin Barrier Function - Day 2	80.26 g/m^2/hr	Standard Deviation 22.229
Product #1	Skin Barrier Function - Day 2	73.10 g/m^2/hr	Standard Deviation 16.557
Product #2	Skin Barrier Function - Day 2	68.36 g/m^2/hr	Standard Deviation 20.387
Product #3	Skin Barrier Function - Day 2	82.63 g/m^2/hr	Standard Deviation 17.149
Product #4	Skin Barrier Function - Day 2	89.77 g/m^2/hr	Standard Deviation 17.47

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2p-value: <0.00195% CI: [-17.3738, -5.3723]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2p-value: <0.00195% CI: [-18.6789, -6.6775]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2p-value: 0.52195% CI: [-7.9571, 4.0444]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2p-value: 0.00695% CI: [2.3925, 14.394]ANCOVA

Secondary

Skin Barrier Function - Day 3

The skin barrier function of the test sites will be evaluated at Day 3 by Trans Epidermal Water Loss (TEWL).

Time frame: Day 3

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Skin Barrier Function - Day 3	15.46 g/m^2/hr	Standard Deviation 18.864
Wounded Uncovered Skin	Skin Barrier Function - Day 3	77.40 g/m^2/hr	Standard Deviation 24.567
Product #1	Skin Barrier Function - Day 3	50.41 g/m^2/hr	Standard Deviation 23.291
Product #2	Skin Barrier Function - Day 3	50.81 g/m^2/hr	Standard Deviation 20.377
Product #3	Skin Barrier Function - Day 3	68.49 g/m^2/hr	Standard Deviation 27.025
Product #4	Skin Barrier Function - Day 3	89.27 g/m^2/hr	Standard Deviation 18.969

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3p-value: <0.00195% CI: [-41.3967, -22.2538]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3p-value: <0.00195% CI: [-36.8727, -17.7298]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3p-value: 0.00595% CI: [-23.2784, -4.1355]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3p-value: 0.03995% CI: [0.4969, 19.6398]ANCOVA

Secondary

Skin Barrier Function - Day 4

The skin barrier function of the test sites will be evaluated at Day 4 by Trans Epidermal Water Loss (TEWL).

Time frame: Day 4

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Skin Barrier Function - Day 4	16.70 g/m^2/hr	Standard Deviation 19.227
Wounded Uncovered Skin	Skin Barrier Function - Day 4	72.49 g/m^2/hr	Standard Deviation 25.078
Product #1	Skin Barrier Function - Day 4	36.32 g/m^2/hr	Standard Deviation 35.19
Product #2	Skin Barrier Function - Day 4	35.19 g/m^2/hr	Standard Deviation 20.969
Product #3	Skin Barrier Function - Day 4	56.14 g/m^2/hr	Standard Deviation 28.921
Product #4	Skin Barrier Function - Day 4	82.46 g/m^2/hr	Standard Deviation 28.101

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4p-value: <0.00195% CI: [-51.0324, -29.7496]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4p-value: <0.00195% CI: [-31.6336, -10.3508]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4p-value: 0.10695% CI: [-1.8871, 19.3957]ANCOVA

Secondary

Skin Barrier Function - Day 5

The skin barrier function of the test sites will be evaluated at Day 5 by Trans Epidermal Water Loss (TEWL).

Time frame: Day 5

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Skin Barrier Function - Day 5	12.77 g/m^2/hr	Standard Deviation 16.829
Wounded Uncovered Skin	Skin Barrier Function - Day 5	58.87 g/m^2/hr	Standard Deviation 25.914
Product #1	Skin Barrier Function - Day 5	30.80 g/m^2/hr	Standard Deviation 21.51
Product #2	Skin Barrier Function - Day 5	32.27 g/m^2/hr	Standard Deviation 23.068
Product #3	Skin Barrier Function - Day 5	44.91 g/m^2/hr	Standard Deviation 32.51
Product #4	Skin Barrier Function - Day 5	67.46 g/m^2/hr	Standard Deviation 27.159

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5p-value: <0.00195% CI: [-29.1785, -8.3374]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5p-value: 0.295% CI: [-3.6303, 17.2107]ANCOVA

Secondary

Skin Barrier Function - Day 6

The skin barrier function of the test sites will be evaluated at Day 6 by Trans Epidermal Water Loss (TEWL).

Time frame: Day 6

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Skin Barrier Function - Day 6	11.94 g/m^2/hr	Standard Deviation 8.699
Wounded Uncovered Skin	Skin Barrier Function - Day 6	47.34 g/m^2/hr	Standard Deviation 20.318
Product #1	Skin Barrier Function - Day 6	21.28 g/m^2/hr	Standard Deviation 8.524
Product #2	Skin Barrier Function - Day 6	22.81 g/m^2/hr	Standard Deviation 11.897
Product #3	Skin Barrier Function - Day 6	31.57 g/m^2/hr	Standard Deviation 17.81
Product #4	Skin Barrier Function - Day 6	53.56 g/m^2/hr	Standard Deviation 28.39

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6p-value: 0.3395% CI: [-4.362, 12.9055]ANCOVA

Secondary

Skin Barrier Function - Day 7

The skin barrier function of the test sites will be evaluated at Day 7 by Trans Epidermal Water Loss (TEWL).

Time frame: Day 7

Arm	Measure	Value (MEAN)	Dispersion
Intact Uncovered Skin	Skin Barrier Function - Day 7	9.80 g/m^2/hr	Standard Deviation 4.252
Wounded Uncovered Skin	Skin Barrier Function - Day 7	30.36 g/m^2/hr	Standard Deviation 16.556
Product #1	Skin Barrier Function - Day 7	21.23 g/m^2/hr	Standard Deviation 12.719
Product #2	Skin Barrier Function - Day 7	19.52 g/m^2/hr	Standard Deviation 7.545
Product #3	Skin Barrier Function - Day 7	25.08 g/m^2/hr	Standard Deviation 17.171
Product #4	Skin Barrier Function - Day 7	39.03 g/m^2/hr	Standard Deviation 25.197

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7p-value: <0.00195% CI: [-21.368, -6.5419]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7p-value: 0.00295% CI: [-18.9563, -4.1302]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7p-value: 0.00895% CI: [-17.4867, -2.6606]ANCOVA

Comparison: Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7p-value: 0.06995% CI: [-0.5447, 14.2814]ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds

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Primary

Secondary

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Microbial Community Diversity - Baseline (Day 0)

Microbial Community Diversity - Day 1

Microbial Community Diversity - Day 14

Microbial Community Diversity - Day 2

Microbial Community Diversity - Day 3

Microbial Community Diversity - Day 4

Microbial Community Diversity - Day 5

Microbial Community Diversity - Day 6

Microbial Community Diversity - Day 7

Microbial Community Evenness - Baseline (Day 0)

Microbial Community Evenness - Day 1

Microbial Community Evenness - Day 14

Microbial Community Evenness - Day 2

Microbial Community Evenness - Day 3

Microbial Community Evenness - Day 4

Microbial Community Evenness - Day 5

Microbial Community Evenness - Day 6

Microbial Community Evenness - Day 7

Microbial Community Richness - Baseline (Day 0)

Microbial Community Richness - (Day 1)

Microbial Community Richness - (Day 14)

Microbial Community Richness - (Day 2)

Microbial Community Richness - (Day 3)

Microbial Community Richness - (Day 4)

Microbial Community Richness - (Day 5)

Microbial Community Richness - (Day 6)

Microbial Community Richness - (Day 7)

Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)

Redness: Wound Area Oxyhemoglobin Level - Day 1

Redness: Wound Area Oxyhemoglobin Level - Day 14

Redness: Wound Area Oxyhemoglobin Level - Day 2

Redness: Wound Area Oxyhemoglobin Level - Day 3

Redness: Wound Area Oxyhemoglobin Level - Day 4

Redness: Wound Area Oxyhemoglobin Level - Day 5

Redness: Wound Area Oxyhemoglobin Level - Day 6

Redness: Wound Area Oxyhemoglobin Level - Day 7

Skin Barrier Function -Baseline (Day 0)

Skin Barrier Function - Day 1

Skin Barrier Function - Day 14

Skin Barrier Function - Day 2

Skin Barrier Function - Day 3

Skin Barrier Function - Day 4

Skin Barrier Function - Day 5

Skin Barrier Function - Day 6

Skin Barrier Function - Day 7