Intralesional Injections of Triamcinolone for Acne Vulgaris

Completed · Not applicable

Conditions studied: Acne Vulgaris

In brief

This proof-of-concept study seeks to investigate the safety of intralesional injections of triamcinolone for acne vulgaris lesions using an Intradermal Needle Adapter.

Key facts

Study ID

NCT06170593

Run by

ACOM Labs

People needed

20

Starts

2022-11-15

Expected to finish

2023-02-14

Last updated by the study team

2023-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Center For Dermatology Clinical Research, Inc — Fremont, California, United States

Full record on ClinicalTrials.gov

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