N/A
N=35
Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT03365934 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Microbial Community Richness - Baseline (Day 0) — 56.5862069; 32.13043478; 43.72413793; 34.03703704 Number of bacterial taxa — p=0.071225
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ADHESIVE BANDAGE #1 (Device); ADHESIVE BANDAGE #2 (Device); ADHESIVE BANDAGE #3 (Device); Antibacterial Bandage with 0.8% BZK (Device); Intact and No Bandage (Other); Wounded and No Bandage (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Microbial Community Richness - Baseline (Day 0) |
56.5862069; 32.13043478; 43.72413793; 34.03703704; 42.39130435; 46.48148148 | 0.071225 |
| PRIMARY Microbial Community Richness - (Day 1) |
53.15625; 58.75862069; 22; 53.5; 42.47368421; 28.83333333 | 0.985332 |
| PRIMARY Microbial Community Richness - (Day 2) |
60.15625; 87.03030303; 20.33333333; 36.65625; 33.7037037; 30.40625 | 0.027774 sig |
| PRIMARY Microbial Community Richness - (Day 3) |
53.44827586; 74.03125; 19.21212121; 38.25925926; 37.88; 30.28125 | 0.0403539 sig |
| PRIMARY Microbial Community Richness - (Day 4) |
66.88461538; 76.23333333; 20.5; 44.35483871; 43.53571429; 25.59375 | 0.882449 |
| PRIMARY Microbial Community Richness - (Day 5) |
61.96; 77.59259259; 19.03225806; 44.03703704; 50.33333333; 25.80645161 | 0.516068 |
| PRIMARY Microbial Community Richness - (Day 6) |
48.5; 75.88888889; 23.55172414; 48.81481481; 40.26315789; 25.63333333 | 0.00526 sig |
| PRIMARY Microbial Community Richness - (Day 7) |
54.54545455; 81.51515152; 31; 45.12; 43.04761905; 30.57575758 | 0.066788 |
| PRIMARY Microbial Community Richness - (Day 14) |
73.1; 66.44444444; 28.34375; 46.21875; 32.32; 30.45454545 | 0.943522 |
| PRIMARY Microbial Community Diversity - Baseline (Day 0) |
1.702946961; 0.938913363; 1.470084856; 1.16250018; 1.355575793; 1.278886018 | 0.193667 |
| PRIMARY Microbial Community Diversity - Day 1 |
1.703357647; 1.45014401; 0.786918525; 1.518890457; 1.060560749; 0.900390717 | 0.92106 |
| PRIMARY Microbial Community Diversity - Day 2 |
1.776794637; 1.866171013; 0.793586986; 1.169519236; 1.327096148; 0.941432164 | 0.998949 |
| PRIMARY Microbial Community Diversity - Day 3 |
1.85115546; 1.765408531; 0.7122095; 1.046670711; 1.322070974; 1.071628134 | 0.99916 |
| PRIMARY Microbial Community Diversity - Day 4 |
1.932633093; 1.88044173; 0.797557627; 1.453888326; 1.513528952; 0.76492761 | 0.999952 |
| PRIMARY Microbial Community Diversity - Day 5 |
1.783329786; 1.664197367; 0.700642641; 1.267584901; 1.480613855; 0.68710958 | 0.997406 |
| PRIMARY Microbial Community Diversity - Day 6 |
1.782776526; 1.799754753; 0.865721173; 1.223240388; 1.425318411; 0.698409234 | 1 |
| PRIMARY Microbial Community Diversity - Day 7 |
1.637800497; 1.765588383; 0.848189016; 1.328769036; 1.367835908; 0.791935871 | 0.996522 |
| PRIMARY Microbial Community Diversity - Day 14 |
1.992920174; 1.729295419; 0.826824832; 1.188271444; 1.362870394; 0.729090928 | 0.862516 |
| PRIMARY Microbial Community Evenness - Baseline (Day 0) |
0.410155753; 0.271955307; 0.402950073; 0.320061269; 0.358334602; 0.325047059 | 0.016628 sig |
| PRIMARY Microbial Community Evenness - Day 1 |
0.437132278; 0.349459879; 0.246062404; 0.389333736; 0.273028286; 0.265726584 | 0.393119 |
| PRIMARY Microbial Community Evenness - Day 2 |
0.42693493; 0.415386732; 0.263575452; 0.322568391; 0.386309873; 0.277342605 | 0.999858 |
| PRIMARY Microbial Community Evenness - Day 3 |
0.455666826; 0.405262792; 0.234966957; 0.279414327; 0.363143499; 0.312661752 | 0.91874 |
| PRIMARY Microbial Community Evenness - Day 4 |
0.451377803; 0.422737764; 0.269049335; 0.38804873; 0.392633921; 0.231556861 | 0.99253 |
| PRIMARY Microbial Community Evenness - Day 5 |
0.418779366; 0.377673266; 0.235666776; 0.330181203; 0.388971323; 0.212340111 | 0.968005 |
| PRIMARY Microbial Community Evenness - Day 6 |
0.446298915; 0.417003638; 0.270297461; 0.31595456; 0.370960196; 0.213078749 | 0.995862 |
| PRIMARY Microbial Community Evenness - Day 7 |
0.410567291; 0.404030653; 0.247507869; 0.354717133; 0.359914043; 0.230659131 | 0.999997 |
| PRIMARY Microbial Community Evenness - Day 14 |
0.454253238; 0.402829439; 0.249502521; 0.308795465; 0.383110745; 0.210741952 | 0.891244 |
| SECONDARY Skin Barrier Function -Baseline (Day 0) |
9.82; 96.94; 101.08; 97.04; 101.43; 98.21 | — |
| SECONDARY Skin Barrier Function - Day 1 |
13.05; 95.68; 92.40; 91.13; 97.91; 97.61 | 0.009 sig |
| SECONDARY Skin Barrier Function - Day 2 |
10.97; 80.26; 73.10; 68.36; 82.63; 89.77 | <0.001 sig |
| SECONDARY Skin Barrier Function - Day 3 |
15.46; 77.40; 50.41; 50.81; 68.49; 89.27 | <0.001 sig |
| SECONDARY Skin Barrier Function - Day 4 |
16.70; 72.49; 36.32; 35.19; 56.14; 82.46 | <0.001 sig |
| SECONDARY Skin Barrier Function - Day 5 |
12.77; 58.87; 30.80; 32.27; 44.91; 67.46 | <0.001 sig |
| SECONDARY Skin Barrier Function - Day 6 |
11.94; 47.34; 21.28; 22.81; 31.57; 53.56 | <0.001 sig |
| SECONDARY Skin Barrier Function - Day 7 |
9.80; 30.36; 21.23; 19.52; 25.08; 39.03 | <0.001 sig |
| SECONDARY Skin Barrier Function - Day 14 |
10.32; 14.58; 16.66; 16.10; 10.07; 16.45 | 0.397 |
| SECONDARY Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0) |
0.82; 0.97; 0.96; 1.00; 0.99; 0.98 | — |
| SECONDARY Redness: Wound Area Oxyhemoglobin Level - Day 1 |
0.83; 1.20; 1.15; 1.12; 1.15; 1.22 | 0.348 |
| SECONDARY Redness: Wound Area Oxyhemoglobin Level - Day 2 |
0.85; 1.21; 1.16; 1.07; 1.18; 1.37 | 0.516 |
| SECONDARY Redness: Wound Area Oxyhemoglobin Level - Day 3 |
0.81; 1.16; 1.08; 1.06; 1.16; 1.33 | 0.292 |
| SECONDARY Redness: Wound Area Oxyhemoglobin Level - Day 4 |
0.81; 1.20; 0.99; 0.99; 1.14; 1.28 | 0.001 sig |
| SECONDARY Redness: Wound Area Oxyhemoglobin Level - Day 5 |
0.81; 1.14; 0.90; 0.96; 1.00; 1.26 | <0.001 sig |
| SECONDARY Redness: Wound Area Oxyhemoglobin Level - Day 6 |
0.80; 1.20; 0.88; 0.95; 0.98; 1.23 | <0.001 sig |
| SECONDARY Redness: Wound Area Oxyhemoglobin Level - Day 7 |
0.78; 1.02; 0.88; 0.89; 0.88; 1.03 | 0.006 sig |
| SECONDARY Redness: Wound Area Oxyhemoglobin Level - Day 14 |
0.79; 0.90; 0.89; 0.85; 0.84; 0.92 | 0.937 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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;
- 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;
Data sourced from ClinicalTrials.gov (NCT03365934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.