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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT03365934
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged 18 to 55 years of age.
2. Fitzpatrick skin types I to III.
3. Must be able to comprehend and follow the requirements of the study
4. Avoid excessive sun exposure
5. Willing to refrain from topical product use on the back for the duration of the study.
6. Subjects must agree not to immerse their bandages in water for the duration of the study.
7. Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control
Exclusion Criteria:
1. Excessively hairy back, acne, scars and pigmentation or nevi t
2. . Pregnant or Lactating, or planning on becoming pregnant;
3. . Known allergies or sensitivities to anesthetics, adhesive bandages, wound treatment products or tapes;
4. . Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
5. Participation in any other clinical study within 30 days of Visit 1;
6. . Subjects who have a health condition and/or pre-existing or dormant dermatologic conditions or who have clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections
7. Subjects who report using prescription or OTC medication (oral or topical) that can make skin more sensitive or influence the skin (i.e. antibiotics, hormones, insulin, etc.)
8. Subjects receiving topical and/or inhaled medications that may alter or compromise the bleeding/healing process
9. Individuals with a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications and/or radiation
10. . Subjects with a known history of keloid or hypertrophic scar formation;
11. Subjects diagnosed with any blood clotting disorder;
12. Hyperthyroidism or hypothyroidism or with active or recently treated (within 1 year) skin cancer, or those in poor nutritional status; 13 Subjects taking oral Vitamin A derivatives such as Accutane, isotretinon, or using retinoic acid in the past 1 year or using topical Vitamin A derivatives in the 3 weeks prior to study start;
14\. Subjects with clinically infected skin lesions; 15. Subjects with cracked or excoriated skin, or other skin problems. 16. Diabetes mellitus that cannot be controlled by diet alone (i.e. requires systemic medications for control); 17. Subjects with friable skin, at the discretion of the Investigator;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03365934
Study Brief:
Protocol Section:
NCT03365934