Self-Administered Intralesional Injections for Acne
The goal of this clinical trial is to test the safety of intralesional injections of triamcinolone self-administered into acne lesions via an injection assistance device. The main question\[s\] it aims to answer are: * is use of the injection assistance device safe? * is delivery of triamcinolone to acne lesions via the injection assistance device efficacious? Participants will self-inject low dose triamcinolone into acne lesions and track lesion response via photos and survey for 14 days following injection.
Conditions:
🦠 Acne Vulgaris
🗓️ Study Start (Actual) 1 February 2023
🗓️ Primary Completion (Estimated) 31 January 2024
✅ Study Completion (Estimated) 31 January 2024
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Fremont, California, United States
📍 Boca Raton, Florida, United States
📍 Hollywood, Florida, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 December 2023
  • First Submitted that Met QC Criteria 15 December 2023
  • First Posted 2 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 December 2023
  • Last Update Posted 2 January 2024
  • Last Verified December 2023