Healthy VolunteersNCT03365934

Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds

A study testing ADHESIVE BANDAGE #1, ADHESIVE BANDAGE #2 and ADHESIVE BANDAGE #3 in people with Healthy Volunteers, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: ADHESIVE BANDAGE #1, ADHESIVE BANDAGE #2 and ADHESIVE BANDAGE #3
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 20 Nov 2017to 12 Feb 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Excessively hairy back, acne, scars and pigmentation or nevi t
. Pregnant or Lactating, or planning on becoming pregnant;
. Known allergies or sensitivities to anesthetics, adhesive bandages, wound treatment products or tapes;
. 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
Participation in any other clinical study within 30 days of Visit 1;
. 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

Show all 13Show fewer

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.)
Subjects receiving topical and/or inhaled medications that may alter or compromise the bleeding/healing process
Individuals with a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications and/or radiation
. Subjects with a known history of keloid or hypertrophic scar formation;
Subjects diagnosed with any blood clotting disorder;
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;

Trial locations and contacts

1 site in 1 country.

United States1 site

TKL Research Inc.
Fair Lawn, New Jersey, 07410

Other trials in United States

About this study

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

Conditions: Healthy Volunteers
Being tested: ADHESIVE BANDAGE #1, ADHESIVE BANDAGE #2, ADHESIVE BANDAGE #3, Antibacterial Bandage with 0.8% BZK, Intact and No Bandage
Keywords: Microflora, Microbiome, skin physiology, Fitzpatrick Skin Types I-III, Tape-stripped wounds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ADHESIVE BANDAGE #1Device
Bandage applied daily to wounded site for 14 days
ADHESIVE BANDAGE #2Device
Bandage applied daily to wounded site for 14 days
ADHESIVE BANDAGE #3Device
Bandage applied daily to wounded site for 14 days
Antibacterial Bandage with 0.8% BZKDevice
bandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days
Intact and No BandageOther
This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.
Wounded and No BandageOther
This test site will be wounded but will not be treated with a bandage, serving as the positive control site.

Study groups in NCT03365934
Study group	Role	What they receive
ADHESIVE BANDAGE #1	Experimental	bandage applied to wounded site. Receives: Device: ADHESIVE BANDAGE #1
ADHESIVE BANDAGE #2	Experimental	bandage applied to wounded site. Receives: Device: ADHESIVE BANDAGE #2
ADHESIVE BANDAGE #3	Experimental	bandage applied to wounded site Receives: Device: ADHESIVE BANDAGE #3
Antibacterial Bandage with 0.8% BZK	Experimental	bandage with 0.8% Benzalkonium Chloride (BZK) applied to wounded site Receives: Device: Antibacterial Bandage with 0.8% BZK
Intact and No Bandage	Other	This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site. Receives: Other: Intact and No Bandage
Wounded and No Bandage	Other	This test site will be wounded and no bandage applied, serving as a positive control site. Receives: Other: Wounded and No Bandage

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (18)

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).
Measured: Day 0
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).
Measured: Day 1
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).
Measured: Day 2
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).
Measured: Day 3
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).
Measured: Day 4
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).
Measured: Day 5
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).
Measured: Day 6
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).
Measured: Day 7
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).
Measured: Day 14
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.
Measured: Day 0
Redness: Wound Area Oxyhemoglobin Level - 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.
Measured: Day 1
Redness: Wound Area Oxyhemoglobin Level - 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.
Measured: Day 2
Redness: Wound Area Oxyhemoglobin Level - 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.
Measured: Day 3
Redness: Wound Area Oxyhemoglobin Level - 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.
Measured: Day 4
Redness: Wound Area Oxyhemoglobin Level - 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.
Measured: Day 5
Redness: Wound Area Oxyhemoglobin Level - 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.
Measured: Day 6
Redness: Wound Area Oxyhemoglobin Level - 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.
Measured: Day 7
Redness: Wound Area Oxyhemoglobin Level - 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.
Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 201712 Feb 2018

First posted8 Dec 2017
Study start20 Nov 2017
Primary completion12 Feb 2018
Study completion12 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03365934
Sponsor's protocol ID: CO-170726100607-SACT
Status last verified: May 2019
First submitted: 16 Nov 2017
Last updated: 4 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Exploratory Study to Evaluate Changes to Skin Microbiome With Tape-stripped Wounds
ClinicalTrials.gov ID: NCT03365934
Acronym / sponsor ID: CO-170726100607-SACT
Conditions: Healthy Volunteers
Keywords: Microflora, Microbiome, skin physiology, Fitzpatrick Skin Types I-III, Tape-stripped wounds
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 20 Nov 2017 (actual)
Primary completion: 12 Feb 2018 (actual)
Study completion: 12 Feb 2018 (actual)
First posted: 8 Dec 2017 (actual)
Results: Posted 4 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
ADHESIVE BANDAGE #1	Experimental	Device: ADHESIVE BANDAGE #1bandage applied to wounded site.
ADHESIVE BANDAGE #2	Experimental	Device: ADHESIVE BANDAGE #2bandage applied to wounded site.
ADHESIVE BANDAGE #3	Experimental	Device: ADHESIVE BANDAGE #3bandage applied to wounded site
Antibacterial Bandage with 0.8% BZK	Experimental	Device: Antibacterial Bandage with 0.8% BZKbandage with 0.8% Benzalkonium Chloride (BZK) applied to wounded site
Intact and No Bandage	Other	Other: Intact and No BandageThis test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.
Wounded and No Bandage	Other	Other: Wounded and No BandageThis test site will be wounded and no bandage applied, serving as a positive control site.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Adults aged 18 to 55 years of age.
Fitzpatrick skin types I to III.
Must be able to comprehend and follow the requirements of the study
Avoid excessive sun exposure
Willing to refrain from topical product use on the back for the duration of the study.

Key exclusion criteria (13 listed)

Excessively hairy back, acne, scars and pigmentation or nevi t
. Pregnant or Lactating, or planning on becoming pregnant;
. Known allergies or sensitivities to anesthetics, adhesive bandages, wound treatment products or tapes;
. 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
Participation in any other clinical study within 30 days of Visit 1;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ADHESIVE BANDAGE #1Bandage applied daily to wounded site for 14 days	Device	ADHESIVE BANDAGE #1
ADHESIVE BANDAGE #2Bandage applied daily to wounded site for 14 days	Device	ADHESIVE BANDAGE #2
ADHESIVE BANDAGE #3Bandage applied daily to wounded site for 14 days	Device	ADHESIVE BANDAGE #3
Antibacterial Bandage with 0.8% BZKbandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days	Device	Antibacterial Bandage with 0.8% BZK
Intact and No BandageThis test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.	Other	Intact and No Bandage
Wounded and No BandageThis test site will be wounded but will not be treated with a bandage, serving as the positive control site.	Other	Wounded and No Bandage

Primary outcome

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

18 secondary outcomes

Skin Barrier Function -Baseline (Day 0)
Time frame: Day 0
Skin Barrier Function - Day 1
Time frame: Day 1
Skin Barrier Function - Day 2
Time frame: Day 2
Skin Barrier Function - Day 3
Time frame: Day 3
Skin Barrier Function - Day 4
Time frame: Day 4
Skin Barrier Function - Day 5
Time frame: Day 5
Skin Barrier Function - Day 6
Time frame: Day 6
Skin Barrier Function - Day 7
Time frame: Day 7
Skin Barrier Function - Day 14
Time frame: Day 14
Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)
Time frame: Day 0
Redness: Wound Area Oxyhemoglobin Level - Day 1
Time frame: Day 1
Redness: Wound Area Oxyhemoglobin Level - Day 2
Time frame: Day 2
Redness: Wound Area Oxyhemoglobin Level - Day 3
Time frame: Day 3
Redness: Wound Area Oxyhemoglobin Level - Day 4
Time frame: Day 4
Redness: Wound Area Oxyhemoglobin Level - Day 5
Time frame: Day 5
Redness: Wound Area Oxyhemoglobin Level - Day 6
Time frame: Day 6
Redness: Wound Area Oxyhemoglobin Level - Day 7
Time frame: Day 7
Redness: Wound Area Oxyhemoglobin Level - Day 14
Time frame: Day 14

Results and safety

Results posted to the registry on 4 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Randomized Subjects	35	33

Primary outcome: Microbial Community Richness - Baseline (Day 0)

Time frame: Baseline (Day 0). Mean (95% Confidence Interval). Unit: Number of bacterial taxa

Measure	Intact Uncovered Skin n = 29	Wounded Uncovered Skin n = 22	Product #1 n = 28	Product #2 n = 27	Product #3 n = 23	Product #4 n = 27
Value	56.5862069 (41.82700101 to 71.34541279)	32.13043478 (21.71828318 to 42.54258639)	43.72413793 (31.41567266 to 56.0326032)	34.03703704 (25.21769482 to 42.85637925)	42.39130435 (28.2925728 to 56.4900359)	46.48148148 (32.28761284 to 60.67535013)

Intact Uncovered Skin vs Wounded Uncovered Skin: p = 0.071225, t-test, 2 sided
Intact Uncovered Skin vs Product #2: p = 0.092027, t-test, 2 sided
Intact Uncovered Skin vs Product #3: p = 0.601716, t-test, 2 sided

Primary outcome: Microbial Community Richness - (Day 1)

Time frame: Day 1. Mean (95% Confidence Interval). Unit: Number of bacterial taxa

Measure	Intact Uncovered Skin n = 32	Wounded Uncovered Skin n = 29	Product #1 n = 27	Product #2 n = 32	Product #3 n = 19	Product #4 n = 24
Value	53.15625 (38.21010189 to 68.10239811)	58.75862069 (47.10408916 to 70.41315222)	22 (18.01079945 to 25.98920055)	53.5 (37.61649637 to 69.38350363)	42.47368421 (27.00391618 to 57.94345224)	28.83333333 (20.99591479 to 36.67075187)

Intact Uncovered Skin vs Wounded Uncovered Skin: p = 0.985332, t-test, 2 sided
Intact Uncovered Skin vs Product #2: p = 1, t-test, 2 sided
Intact Uncovered Skin vs Product #3: p = 0.870459, t-test, 2 sided

Primary outcome: Microbial Community Richness - (Day 2)

Time frame: Day 2. Mean (95% Confidence Interval). Unit: Number of bacterial taxa

Measure	Intact Uncovered Skin n = 32	Wounded Uncovered Skin n = 33	Product #1 n = 33	Product #2 n = 32	Product #3 n = 27	Product #4 n = 32
Value	60.15625 (45.95442154 to 74.35807846)	87.03030303 (64.50676969 to 109.5538364)	20.33333333 (15.69936368 to 24.96730299)	36.65625 (30.26643624 to 43.04606376)	33.7037037 (22.14710131 to 45.2603061)	30.40625 (23.74762413 to 37.06487587)

Intact Uncovered Skin vs Wounded Uncovered Skin: p = 0.027774, t-test, 2 sided
Intact Uncovered Skin vs Product #2: p = 0.08431, t-test, 2 sided
Intact Uncovered Skin vs Product #3: p = 0.049247, t-test, 2 sided

Primary outcome: Microbial Community Richness - (Day 3)

Time frame: Day 3. Mean (95% Confidence Interval). Unit: Number of bacterial taxa

Measure	Intact Uncovered Skin n = 29	Wounded Uncovered Skin n = 32	Product #1 n = 33	Product #2 n = 27	Product #3 n = 25	Product #4 n = 32
Value	53.44827586 (40.61259145 to 66.28396027)	74.03125 (60.80846371 to 87.25403629)	19.21212121 (16.49174219 to 21.93250024)	38.25925926 (29.78367344 to 46.73484508)	37.88 (23.44927006 to 52.31072994)	30.28125 (23.87137083 to 36.69112917)

Intact Uncovered Skin vs Wounded Uncovered Skin: p = 0.0403539, t-test, 2 sided
Intact Uncovered Skin vs Product #2: p = 0.2953049, t-test, 2 sided
Intact Uncovered Skin vs Product #3: p = 0.290551, t-test, 2 sided

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events were collected from the time the informed consent was obtained through the subject's last study procedure/visit. Serious adverse events were collected through and including 30 calendar days after administration of the subject's last dose or exposure to IP.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Randomized Subjects	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philip Lastella, MD principal investigator

TKL Research, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ADHESIVE BANDAGE #1, ADHESIVE BANDAGE #2 and ADHESIVE BANDAGE #3 in people with Healthy Volunteers, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbial Community Richness - Baseline (Day 0) (time frame: Baseline (Day 0)). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03365934.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.