Intralesional Injections of Triamcinolone for Acne Vulgaris

• Status: Completed
• Trial end date: 2023-02-14
• Target enrollment: 0
• Participant gender: All

Summary

This proof-of-concept study seeks to investigate the safety of intralesional injections of triamcinolone for acne vulgaris lesions using an Intradermal Needle Adapter.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ACOM Labs
• Treatments: Triamcinolone

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.