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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT06195605
Eligibility Criteria:
Inclusion Criteria:
* Subjects must understand and sign the informed consent prior to participation
* Subjects must be in generally good health
* Subjects must be able and willing to comply with the requirements of the protocol
Exclusion Criteria:
* Pregnant, plan to become pregnant during the study, or are nursing a child. Participants will be asked to self-report pregnancy
* Individuals with bleeding disorders
* Tend to heal poorly or form very thick scars called keloids
* Have a lidocaine sensitivity, including those with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
* Individuals with active inflammation or infection of the skin, including active herpes infection.
* Have a significant medical history or concurrent condition which the investigator(s) feel is not safe for study participation, including history of frequent herpes infections, and subjects planning to be exposed to excessive sun, Ultraviolet lamps and extreme cold weather during the first week after injection.
* History of allergies to gram positive bacterial proteins
* Individuals with who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
* Have an active inflammation or infection of the skin near the site of injection
* Are taking any medications that suppress your immune system
* Have severe allergies to medications or other things that we believe might make participation unsafe for you
* Have a history of connective tissue diseases, such as:
* rheumatoid arthritis
* scleroderma
* polymyositis/dermatomyositis
* systemic lupus erythematosus (SLE)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT06195605
Study Brief:
Protocol Section:
NCT06195605