Status:
UNKNOWN
Self-Administered Intralesional Injections for Acne
Lead Sponsor:
ACOM Labs
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 aim...
Detailed Description
This is an open-label, prospective, single-arm study. Approximately 150 subjects will be enrolled at approximately 3 study sites. All subjects will receive standard-of-care intralesional injection wi...
Eligibility Criteria
Inclusion
- 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.
- Diagnosed with facial acne vulgaris.
- 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.
- Owner of smartphone with capacity for front-facing photography and app download from Apple App Store or Google Play.
- Able to follow study instructions and likely to comply with virtual follow-up requirements.
- In good general health as determined by medical history at the time of screening (Investigator discretion).
- Sign the IRB-approved ICF (including HIPAA authorization) prior to any study-related procedures being performed.
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06186596
Start Date
February 1 2023
End Date
January 31 2024
Last Update
January 2 2024
Active Locations (3)
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1
Center For Dermatology Clinical Research, Inc
Fremont, California, United States, 94538
2
Skin Care Research
Boca Raton, Florida, United States, 33486
3
Skin Care Research
Hollywood, Florida, United States, 33021