A Study to Assess Wound Healing Efficacies of Different Clean, Treat, and Protect Wound Care Regimens Compared to Standard of Care and Untreated

Wound Healing Clinical Trial

Official title:

A 16-Day, Single-Center, Randomized, Comparator-Controlled Study to Assess Wound Healing Efficacies of Different Clean, Treat, and Protect Wound Care Regimens Compared to Standard of Care and Untreated

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05045183
• Other study ID #: CCSTOH003808
• Secondary ID: CCSTOH003808
• Status: Completed
• Phase: N/A
• Start date: September 8, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: October 2022
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the healing rates of wounds treated with various wound care regimens including antiseptic wound wash, topical antibiotic treatment, adhesive bandages, and/or hydrocolloid bandages.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 15, 2021
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• Fitzpatrick Skin Type I to III

• Uniform skin color on both volar forearms

• Generally in good health based on medical history reported by the participant, and as verified by the Principal Investigator (PI) assessment and brief interview of medical history

• Able to read, write, speak, and understand English

• Individual must be able to understand the nature, risk, and relevance of the study

• Individual has signed the Consent for Photograph Release and informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure after the nature of the study has been fully explained

• Willing to undergo topical anesthetic and laser wound treatment on the volar forearms

• Individual must agree to attend all required study visits, cooperate/follow all study instructions, and participate with all the procedures for the duration of the study and return to the clinical site for all scheduled visits as required by the investigator

• Willing to wear long sleeves when going outdoors during the study to protect the test areas from exposure to sunlight. Individuals must agree to avoid exposing their forearms to sunlight (including tanning booths) throughout the entire study period

• Individual must agree not to immerse their bandages in water for the duration of the study. Participants will only be allowed to shower during the course of the study (no swimming, baths, hot tubs, Et cetera [etc.]) Individuals must agree not to shower within 2 hours prior to each scheduled visit

• Individuals must agree not to use lotions, creams, moisturizers, cosmetics, or sunscreens on their forearms (sites of wounds) for the entire duration of the study

• Individuals must agree to refrain from the use of any daily cleanser or washoff products other than the auxiliary cleanser that will be provided at screening (that is, [Day -7 to Day -3]), for use on forearms throughout the study

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, cardiovascular, hepatic, or kidney disease

• Presents with a known history of keloid or hypertrophic scar formation, cracked or excoriated skin, clinical infected skin lesions, or other skin problems that would in the opinion of the PI or Study Physician, confound the study results, increase risk to the participant, or interfere with study evaluations (example, active psoriasis anywhere on the body, seborrheic dermatitis, atopic dermatitis, other skin dermatoses, etc.)

• Has excessive hair, acne, scars, pigmentation, tattoos, or friable skin on either volar forearm that could interfere with evaluations or study procedures (at the discretion of the PI)

• Has a known history of severe systemic immune system disorders such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), Scleroderma, chronic connective tissue disorders, Poly Arteritis Nodosa, or immunodeficiency, including human immunodeficiency viruses (HIV) infection

• Has a history of a confirmed Coronavirus Disease 2019 (COVID-19) infection within 30 days prior to Visit 1

• Has had contact with a COVID-19 infected person within 14 days prior to Visit 1

• Individual or a member of the individual's household who has traveled internationally within 14 days prior to Visit 1

• Has experienced any of the following self-reported symptoms of COVID-19 within 2 weeks prior to the study visit: a) Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches) conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever, or chest pain/tightness; b) Temperature greater than or equal to (>=) 37.2 degree Celsius (°C)/99.5 degree Fahrenheit (°F), measured; c) Use of fever reducers within 2 days prior to each on-site study visit

• Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication

• Has self-reported uncontrolled chronic diseases such as hypertension, hyperthyroidism, hypothyroidism, or active or recently treated (within 1 year) skin cancer, or those in known poor nutritional status

• Is taking a medication that would mask an Adverse Event (AE), confound the study results, or alter or compromise the bleeding/healing process including: a) Antibiotics, oral corticosteroids, immunosuppressive agents, anti-coagulants, antiplatelet drugs, cytotoxic agents, continuous aspirin therapy, chemotherapy, or daily medications for chronic asthma, within 1 month before Visit 1; b) Non-steroidal anti-inflammatory drugs or steroidal drugs within 5 days before Visit 1. Low dose aspirin (81 milligrams [mg] per day) is allowed; c) Antihistamines within 2 weeks before Visit 1

• Is self-reported to be pregnant, lactating or planning to become pregnant during the study

• Has taken/used (oral or topical) vitamin A derivatives such as Accutane, isotretinoin, or retinoic acid within the past 1 year, or using topical Vitamin A derivatives on the forearms in the 3 weeks prior to Visit 1.

• Has used topical leave-on products on the volar forearms within 1 week prior to Visit 1

• Is participating or has participated in 1) any clinical trial involving a topical or systemic investigational drug within 30 days prior to Visit 1 or 2) any other clinical study within 10 days prior to Visit 1

• Has a body mass index (BMI) above 35 on the BMI scale. BMI will be calculated using height and weight measurements obtained by trained study personnel

• Is self-reported to be an alcohol or drug abuser, or with any other known severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the PI, would make the participant inappropriate for entry into this study

• Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor

• Has a relative, partner, or staff of any clinical research site personnel, or either is or lives with someone who is a current employee of any company that makes or markets adhesive bandages or first aid products

• Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study or viewed by the PI as not being able to complete the study

Related Conditions & MeSH terms

• Wound Healing
• Wounds and Injuries

Intervention

Device:
• SoC Adhesive Bandage
On the randomized wound site, a SoC adhesive bandage will be applied.

Drug:
• Antibiotic Ointment
On the randomized wound site, a antibiotic ointment will be applied.
• Antiseptic Wash
On the randomized wound site, a antiseptic wash will be applied.

Device:
• Hydrocolloid Pad
On the randomized wound site, hydrocolloid pad will be applied.

Locations

Country	Name	City	State
United States	SGS Stephens, Inc. Dallas Research Center	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc. (J&JCI)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bernard DB. Chapter 41: Minor Burns, Sunburns, and Wounds. In Krinsky DL, Ferreri SP, and Hemstreet B., et al., Handbook of nonprescription drugs: An interactive approach to self-care (19th ed.) Washington, DC: American Pharmacists Association. doi:https://doi-org.jerome.stjohns.edu/10.21019/9781582122656.ch41

Cuts and scrapes: First aid. (2019, October 29). Retrieved January 22, 2021, from https://www.mayoclinic.org/first-aid/first-aid-cuts/basics/art-20056711

Mancini AJ, Sookdeo-Drost S, Madison KC, Smoller BR, Lane AT. Semipermeable dressings improve epidermal barrier function in premature infants. Pediatr Res. 1994 Sep;36(3):306-14. — View Citation

NIH Publication No. 98-4083 (1998, September). Adapted from Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report. Retrieved from URL. https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmi_tbl.htm. 22 May 2019.

Trookman NS, Rizer RL, Weber T. Treatment of minor wounds from dermatologic procedures: a comparison of three topical wound care ointments using a laser wound model. J Am Acad Dermatol. 2011 Mar;64(3 Suppl):S8-15. doi: 10.1016/j.jaad.2010.11.011. Epub 2011 Jan 17. — View Citation

WINTER GD. Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature. 1962 Jan 20;193:293-4. — View Citation

Winter GD. Some factors affecting skin and wound healing. J Tissue Viability. 2006 May;16(2):20-3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Healing Score	Composite healing score will be calculated from clinical grading of wound healing parameters as (general wound appearance score plus [+] smoothness score + epithelial confluence score) minus [-] (erythema score + edema score + crusting/scabbing score). Composite healing score on a 25-point scale (-12 [no healing] to +12 [towards healing]) is indicative of extent of wound healing and will be calculated for each wound site at each evaluation day.	Day 0 through Day 7
Primary	Composite Healing Score	Composite healing score will be calculated from clinical grading of wound healing parameters as (general wound appearance score + smoothness score + epithelial confluence score) - (erythema score + edema score + crusting/scabbing score). Composite healing score on a 25-point scale (-12 [no healing] to +12 [towards healing]) is indicative of extent of wound healing and will be calculated for each wound site at each evaluation day.	Day 16
Secondary	Clinical Grading of Wound Healing of Erythema	Clinical grading of wound healing of erythema will be reported. It will be evaluated on a scale of 0 to 4 with 0=none/absent, 1=mild, 2=moderate, 3=marked, and 4=severe, with higher scores indicating a worse outcome.	Day 0 through Day 7, Day 16
Secondary	Clinical Grading of Wound Healing of Edema	Clinical grading of wound healing of edema will be reported. It will be evaluated on a scale of 0 to 4 with 0=none/absent, 1=mild, 2=moderate, 3=marked, and 4=severe, with higher scores indicating a worse outcome.	Day 0 through Day 7, Day 16
Secondary	Clinical Grading of Wound Healing of General Wound Appearance	Clinical grading of wound healing of general wound appearance will be reported. It is evaluated on a scale from 0 to 4 with 0=poor, 1=fair, 2=good, 3=very good, 4=excellent with higher scores indicating a better outcome.	Day 0 through Day 7, Day 16
Secondary	Clinical Grading of Wound Healing of Smoothness	Clinical grading of wound healing of smoothness of popped pimple as assessed by trained grader will be reported. It will be evaluated on a scale of 0 to 4 with 0=rough, uneven wound, 1=mild smoothness, 2=moderate smoothness, 3=extensive smoothness, and 4=complete smooth, even wound, with higher scores indicating a better outcome.	Day 0 through Day 7, Day 16
Secondary	Clinical Grading of Wound Healing of Epithelial Confluence	Clinical grading of wound healing of epithelial confluence will be reported. It will be evaluated on a scale from 0 to 4 with 0=none (no epithelial coverage), 1=slight (up to 30 percent [%]), 2=moderate (31% to 60%), 3=extensive (61% to 90%), and 4=almost complete or complete (91% to 100%, covered with a full layer of new epithelial growth), with higher scores indicating a worse outcome.	Day 0 through Day 7, Day 16
Secondary	Clinical Grading of Wound Healing of Crusting/Scabbing	Clinical grading of wound healing of crusting/scabbing will be reported. It will be evaluated on a scale of 0 to 4 with 0=none, 1=slight (up to 30%), 2=moderate (31% to 60%), 3=extensive (61% to 90%), and 4=almost complete or complete (91% to 100%), with higher scores indicating a worse outcome.	Day 0 through Day 7, Day 16
Secondary	Wound Healing Process Assessment Score	Wound healing process assessment of each test site will be performed and a score of "0" or "1" will be assigned where 0=primary healing (the wound heals by primary epithelial tissue), and 1=secondary healing (the wound heals through the stage of formation of connective tissue).	Day 16
Secondary	Painful Score with Arm Resting by Side (Participant's Self-assessment Questionnaire)	Painful score with arm resting by side based on participants self-assessment questionnaire score (question 1) will be reported. Participants will be asked to rate each wound for pain/soreness in resting position as score from 0 (no pain) to 10 (severe pain).	Day 0 through Day 7, Day 16
Secondary	Pain Duration with Arm Resting by Side (Participant's Self-assessment Questionnaire)	Participants will be asked to rate the pain as either brief, periodic, or constant in arm resting position with the Self-assessment questionnaire (question 2).	Day 0 through Day 7, Day 16
Secondary	Painful Score with Arm in Normal Motion (Participant's Self-assessment Questionnaire)	Painful Score based on participants self-assessment questionnaire score (question 3) will be reported. Participants will be asked to rate each wound for pain/soreness in normal position as score from 0 (no pain) to 10 (severe pain).	Day 0 through Day 7, Day 16
Secondary	Pain Duration with Arm in Normal Motion (Participant's Self-assessment Questionnaire)	Participants will be asked to rate the pain as either brief, periodic, or constant in arm normal motion with the Self-Assessment Questionnaire (question 4).	Day 0 through Day 7, Day 16
Secondary	Itchy Score of Wound Site (Participant's Self-assessment Questionnaire)	Itchy score based on participants self-assessment questionnaire score (question 5) will be reported. Participants will be asked to rate each wound for itchiness as score from 0 (no itch) to 10 (severe itch).	Day 0 through Day 7, Day 16

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