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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT06170593
Eligibility Criteria:
Inclusion Criteria:
* Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline.
* Diagnosed with facial acne vulgaris.
* At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is amenable to intralesional injection of triamcinolone.
* Able to follow study instructions and likely to complete all required visits.
* In good general health as determined by medical history at the time of screening (Investigator discretion).
* Sign the IRB-approved informed consent form (including HIPAA authorization) prior to any study-related procedures being performed
Exclusion Criteria:
* Female subjects who are pregnant or breast-feeding.
* Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection.
* Active cutaneous viral infection in any treatment area at Baseline.
* Have concomitant skin disease or infection (other than acne) or presence of skin comorbidities in the areas of skin where study device will be used.
* History of poor cooperation or unreliability (Investigator discretion).
* Planning to move out of the area prior to study completion.
* Subjects who are investigational site staff members or family members of such employees.
* Exposure to any other investigational /device within 30 days prior to Visit 1.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06170593
Study Brief:
Protocol Section:
NCT06170593