Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: ADHESIVE BANDAGE #1; Device: ADHESIVE BANDAGE #2; Device: ADHESIVE BANDAGE #3; Device: Antibacterial Bandage with 0.8% BZK; Other: Intact and No Bandage; Other: Wounded and No Bandage

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • TKL Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADHESIVE BANDAGE #1; bandage applied to wounded site.	Device: ADHESIVE BANDAGE #1; Bandage applied daily to wounded site for 14 days
Experimental: ADHESIVE BANDAGE #2; bandage applied to wounded site.	Device: ADHESIVE BANDAGE #2; Bandage applied daily to wounded site for 14 days
Experimental: ADHESIVE BANDAGE #3; bandage applied to wounded site	Device: ADHESIVE BANDAGE #3; Bandage applied daily to wounded site for 14 days
Experimental: Antibacterial Bandage with 0.8% BZK; bandage with 0.8% Benzalkonium Chloride (BZK) applied to wounded site	Device: Antibacterial Bandage with 0.8% BZK; bandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days
Other: Intact and No Bandage; This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.	Other: Intact and No Bandage; This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.
Other: Wounded and No Bandage; This test site will be wounded and no bandage applied, serving as a positive control site.	Other: Wounded and No Bandage; This test site will be wounded but will not be treated with a bandage, serving as the positive control site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Day 1
Microbial Community Diversity - Day 2	Swabs will be collected on the back at Day 2 for analysis based on the Shannon Index.	Day 2
Microbial Community Diversity - Day 3	Swabs will be collected on the back at Day 3 for analysis based on the Shannon Index.	Day 3
Microbial Community Diversity - Day 4	Swabs will be collected on the back at Day 4 for analysis based on the Shannon Index.	Day 4
Microbial Community Diversity - Day 5	Swabs will be collected on the back at Day 5 for analysis based on the Shannon Index.	Day 5
Microbial Community Diversity - Day 6	Swabs will be collected on the back at Day 6 for analysis based on the Shannon Index.	Day 6
Microbial Community Diversity - Day 7	Swabs will be collected on the back at Day 7 for analysis based on the Shannon Index.	Day 7
Microbial Community Diversity - Day 14	Swabs will be collected on the back at Day 14 for analysis based on the Shannon Index.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	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).	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	Day 14

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Investigators: Principal Investigator: Philip Lastella, MD, TKL Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): February 12, 2018
• Study Completion (Actual): February 12, 2018

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Microbiome; Microflora; skin physiology; Fitzpatrick Skin Types I-III; Tape-stripped wounds
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: CO-170726100607-SACT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes