Status:
COMPLETED
Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds
Lead Sponsor:
Johnson & Johnson Consumer Inc. (J&JCI)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
NA
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 18-5...
Eligibility Criteria
Inclusion
- 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
- 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;
- 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;
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2018
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03365934
Start Date
November 20 2017
End Date
February 12 2018
Last Update
June 4 2019
Active Locations (1)
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1
TKL Research Inc.
Fair Lawn, New Jersey, United States, 07410