Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03365934

Run by

Johnson & Johnson Consumer Inc. (J&JCI)

People needed

35

Starts

2017-11-20

Expected to finish

2018-02-12

Last updated by the study team

2019-06-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

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

Full record on ClinicalTrials.gov

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