Self-Administered Intralesional Injections for Acne

Eligibility Criteria

• 1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative UPT at Baseline.
• 2. Diagnosed with facial acne vulgaris.
• 3. At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is clinically indicated for standard-of-care intralesional injection(s) of triamcinolone.
• 4. Owner of smartphone with capacity for front-facing photography and app download from Apple App Store or Google Play.
• 5. Able to follow study instructions and likely to comply with virtual follow-up requirements.
• 6. In good general health as determined by medical history at the time of screening (Investigator discretion).
• 7. Sign the IRB-approved ICF (including HIPAA authorization) prior to any study-related procedures being performed.
• 1. Female subjects who are pregnant or breast-feeding.
• 2. Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection.
• 3. Active cutaneous viral infection in any treatment area at Baseline.
• 4. 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.
• 5. History of poor cooperation or unreliability (Investigator discretion).
• 6. Subjects who are investigational site staff members or family members of such employees.
• 7. Exposure to any other investigational device within 30 days prior to Visit 1.