Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds

Johnson & Johnson (J&J)

Status: Completed

Conditions: Healthy Volunteers

Treatments: Device: ADHESIVE BANDAGE #3; Device: Antibacterial Bandage with 0.8% BZK; Device: ADHESIVE BANDAGE #2; Device: ADHESIVE BANDAGE #1; Other: Intact and No Bandage; Other: Wounded and No Bandage

Study type: Interventional

Funder types: Industry

Identifiers

NCT03365934

CO-170726100607-SACT

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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;

13. 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

35 participants in 6 patient groups

ADHESIVE BANDAGE #1

Experimental group

Description:

bandage applied to wounded site.

Treatment:

Device: ADHESIVE BANDAGE #1

ADHESIVE BANDAGE #2

Experimental group

Description:

bandage applied to wounded site.

Treatment:

Device: ADHESIVE BANDAGE #2

ADHESIVE BANDAGE #3

Experimental group

Description:

bandage applied to wounded site

Treatment:

Device: ADHESIVE BANDAGE #3

Antibacterial Bandage with 0.8% BZK

Experimental group

Description:

bandage with 0.8% Benzalkonium Chloride (BZK) applied to wounded site

Treatment:

Device: Antibacterial Bandage with 0.8% BZK

Intact and No Bandage

Other group

Description:

This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.

Treatment:

Other: Intact and No Bandage

Wounded and No Bandage

Other group

Description:

This test site will be wounded and no bandage applied, serving as a positive control site.

Treatment:

Other: Wounded and No Bandage