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 @ 2:25 AM
Ignite Modification Date:
2025-12-25 @ 2:25 AM
NCT ID:
NCT05202834
Eligibility Criteria:
Inclusion Criteria:
-1. Fitzpatrick skin type I-VI. 2. Male or female. 3. Subjects must be between 25 and 75 years of age. 4. Subjects must have ability to get treatment and biopsy from tissue in the abdomen or Buttock.
5\. Subjects must read, understand, and sign the Informed Consent. 6. Subjects must be willing and able to comply with all follow-up requirements.
Exclusion Criteria:
1. Subjects must not have active localized or systemic infections.
2. Lidocaine or epinephrine allergy.
3. Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid scar formation), atrophic dermatitis or immunologic abnormalities such as vitiligo.
4. Subjects must not have had treatments with 5FU, hydroquinone, diclofenac, imiquimod, retinoids, or PDT within one month prior to enrollment.
5. Subjects must not currently be taking Accutane, or have taken Accutane within the last 6 months.
6. Subjects must not have a known allergy to the following topical products: lidocaine (numbing cream).
7. Subject must not have used topical steroids or retinoids within the last 3 months on treatment surfaces.
8. Subjects must not have a personal history of malignant melanoma, keloid scars, generalized psoriasis or systemic diseases that would preclude the use of topical anesthesia.
9. Subjects must agree to refrain from using cosmeceutical agents or topical agents during the course of the study, except as directed by study investigators.
10. Subjects must not be pregnant or breastfeeding.
11. Active sunburn or excessively tanned skin
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05202834
Study Brief:
Protocol Section:
NCT05202834