Clinical trial NCT04040933: A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
Official title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2019-08-01
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type II or III
* Uniform skin color on both volar forearms
* Generally in good health based on medical history reported by the participant
* -Individual has signed the Photographic Release and Informed Consent Documents along with (HIPAA) disclosure
* Willing to have temporary (semi-permanent) dot-tattoos applied to the volar forearms

Exclusion Criteria:

* Has known allergies, hypersensitivity, or adverse reactions to anesthetics, adhesive bandages, latex, wound treatment products, or any component/ingredient present in the Investigational Products (IPs)/auxiliary/ancillary products
* Has a known history of a blood-clotting disorder, keloid formation, or a cardiovascular, hepatic, or renal disease
* Presents with a skin condition that would, in the opinion of the PI or Study Physician, confound study results, increase risk to participant, or interfere with study evaluations
* Has excessive hair or tattoos on either volar forearm
* Has a known history of severe systemic immune system disorders
* Has self-reported Type 1 or Type 2 diabetes
* Has self-reported uncontrolled chronic diseases
* Is taking medication that would mask an adverse event, confound study results or alter/compromise the bleeding/healing process
* Is self-reported to be pregnant or planning to become pregnant
* Has a body mass index (BMI) above 35
* Is self-reported to be an alcohol or drug abuser
* Has participated in another clinical trial within 10 days
* Either is or lives with someone who is a current employee of any company that makes/markets adhesive bandages or first-aid products

Primary outcomes:
measure: Time to Complete Wound Healing
timeFrame: Up to Day 16
Secondary outcomes:
measure: Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
timeFrame: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
measure: Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
timeFrame: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
measure: Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
timeFrame: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
measure: Change From Baseline in Composite Scar Score
timeFrame: Baseline and Day 28
measure: Change From Baseline in Painful Score With Arm Resting by Side
timeFrame: Baseline, Day 1, 2, 3 and 4
measure: Change From Baseline in Painful Score With Arm in Normal Motion
timeFrame: Baseline, Day 1, 2, 3 and 4
measure: Change From Baseline in Itchy Score
timeFrame: Baseline, Day 1, 2, 3 and 4
measure: Number of Participants With Pain Duration With Arm Resting by Side
timeFrame: Day 1, 2, 3 and 4
measure: Number of Participants With Pain Duration With Arm in Normal Motion
timeFrame: Day 1, 2, 3 and 4
Other outcomes:
Locations:
city: Richardson
country: United States
facility: Thomas J. Stephens
state: Texas
Study officials:
affiliation: Thomas J. Stephens & Associates, Inc.
name: Lily Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: