Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:1/11/2018
Start Date:November 20, 2017
End Date:February 16, 2018
Contact:Amisha Parikh-Das, Ph.D. MPH
Email:AParikh1@its.jnj.com
Phone:973-255-8701

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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.


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;
We found this trial at
1
site
Fair Lawn, New Jersey 07410
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mi
from
Fair Lawn, NJ
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