NCT03365934

Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds

Randomized, Exploratory Study to Evaluate Changes to Skin Microbiome With Tape-stripped Wounds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	ADHESIVE BANDAGE #1	Bandage applied daily to wounded site for 14 days
DEVICE	ADHESIVE BANDAGE #2	Bandage applied daily to wounded site for 14 days
DEVICE	ADHESIVE BANDAGE #3	Bandage applied daily to wounded site for 14 days
DEVICE	Antibacterial Bandage with 0.8% BZK	bandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days
OTHER	Intact and No Bandage	This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.
OTHER	Wounded and No Bandage	This test site will be wounded but will not be treated with a bandage, serving as the positive control site.

Timeline

• Start date: 2017-11-20
• Primary completion: 2018-02-12
• Completion: 2018-02-12
• First posted: 2017-12-08
• Last updated: 2019-06-04
• Results posted: 2019-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study