Status:
COMPLETED
Intralesional Injections of Triamcinolone for Acne Vulgaris
Lead Sponsor:
ACOM Labs
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
This is an open-label, prospective, single-arm study. Approximately 20 subjects will be enrolled at 1 study site. All subjects will receive treatment with the study protocol (i.e., intralesional inje...
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 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
- 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.
Key Trial Info
Start Date :
November 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06170593
Start Date
November 15 2022
End Date
February 14 2023
Last Update
December 14 2023
Active Locations (1)
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1
Center For Dermatology Clinical Research, Inc
Fremont, California, United States, 94538