Self-Administered Intralesional Injections for Acne

Launched by ACOM LABS · Dec 15, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to treat acne by allowing patients to give themselves injections of a medication called triamcinolone directly into acne spots. The main goals of the study are to see if using a special device for these self-injections is safe and effective. Participants will take part in the study if they are at least 18 years old, have been diagnosed with facial acne, and have at least one acne lesion that needs treatment. They will also need to be able to use a smartphone to take pictures of their acne and answer some questions about their experience over a 14-day period after the injection.

If you or someone you know is interested in participating, it’s important to know that there are some requirements. For example, participants should not be pregnant or breastfeeding, and they should not have any allergies to triamcinolone. Throughout the trial, participants will be guided on how to use the injection device and will be asked to follow up virtually to share their progress. This study aims to find out if this self-injection method can help improve acne treatment in a safe and effective way.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.