Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT04040933
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT04040933
Study Brief:
Protocol Section:
NCT04040933