Clinical trial NCT03365934: Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds
Official title: Randomized, Exploratory Study to Evaluate Changes to Skin Microbiome With Tape-stripped Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Microflora
Microbiome
skin physiology
Fitzpatrick Skin Types I-III
Tape-stripped wounds
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2017-12-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Microbial Community Richness - Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Microbial Community Richness - (Day 1)
timeFrame: Day 1
measure: Microbial Community Richness - (Day 2)
timeFrame: Day 2
measure: Microbial Community Richness - (Day 3)
timeFrame: Day 3
measure: Microbial Community Richness - (Day 4)
timeFrame: Day 4
measure: Microbial Community Richness - (Day 5)
timeFrame: Day 5
measure: Microbial Community Richness - (Day 6)
timeFrame: Day 6
measure: Microbial Community Richness - (Day 7)
timeFrame: Day 7
measure: Microbial Community Richness - (Day 14)
timeFrame: Day 14
measure: Microbial Community Diversity - Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Microbial Community Diversity - Day 1
timeFrame: Day 1
measure: Microbial Community Diversity - Day 2
timeFrame: Day 2
measure: Microbial Community Diversity - Day 3
timeFrame: Day 3
measure: Microbial Community Diversity - Day 4
timeFrame: Day 4
measure: Microbial Community Diversity - Day 5
timeFrame: Day 5
measure: Microbial Community Diversity - Day 6
timeFrame: Day 6
measure: Microbial Community Diversity - Day 7
timeFrame: Day 7
measure: Microbial Community Diversity - Day 14
timeFrame: Day 14
measure: Microbial Community Evenness - Baseline (Day 0)
timeFrame: Day 0
measure: Microbial Community Evenness - Day 1
timeFrame: Day 1
measure: Microbial Community Evenness - Day 2
timeFrame: Day 2
measure: Microbial Community Evenness - Day 3
timeFrame: Day 3
measure: Microbial Community Evenness - Day 4
timeFrame: Day 4
measure: Microbial Community Evenness - Day 5
timeFrame: Day 5
measure: Microbial Community Evenness - Day 6
timeFrame: Day 6
measure: Microbial Community Evenness - Day 7
timeFrame: Day 7
measure: Microbial Community Evenness - Day 14
timeFrame: Day 14
Secondary outcomes:
measure: Skin Barrier Function -Baseline (Day 0)
timeFrame: Day 0
measure: Skin Barrier Function - Day 1
timeFrame: Day 1
measure: Skin Barrier Function - Day 2
timeFrame: Day 2
measure: Skin Barrier Function - Day 3
timeFrame: Day 3
measure: Skin Barrier Function - Day 4
timeFrame: Day 4
measure: Skin Barrier Function - Day 5
timeFrame: Day 5
measure: Skin Barrier Function - Day 6
timeFrame: Day 6
measure: Skin Barrier Function - Day 7
timeFrame: Day 7
measure: Skin Barrier Function - Day 14
timeFrame: Day 14
measure: Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)
timeFrame: Day 0
measure: Redness: Wound Area Oxyhemoglobin Level - Day 1
timeFrame: Day 1
measure: Redness: Wound Area Oxyhemoglobin Level - Day 2
timeFrame: Day 2
measure: Redness: Wound Area Oxyhemoglobin Level - Day 3
timeFrame: Day 3
measure: Redness: Wound Area Oxyhemoglobin Level - Day 4
timeFrame: Day 4
measure: Redness: Wound Area Oxyhemoglobin Level - Day 5
timeFrame: Day 5
measure: Redness: Wound Area Oxyhemoglobin Level - Day 6
timeFrame: Day 6
measure: Redness: Wound Area Oxyhemoglobin Level - Day 7
timeFrame: Day 7
measure: Redness: Wound Area Oxyhemoglobin Level - Day 14
timeFrame: Day 14
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL Research Inc.
state: New Jersey
Study officials:
affiliation: TKL Research, Inc.
name: Philip Lastella, MD
role: PRINCIPAL_INVESTIGATOR
References: