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

• Status: Completed
• Trial end date: 2021-10-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents, Local

Criteria

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