This proof-of-concept study seeks to investigate the safety of intralesional injections of triamcinolone for acne vulgaris lesions using an Intradermal Needle Adapter.
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 injection with triamcinolone) at Visit 1 (Day 1). Subjects will then attend in-clinic visits at Visit 2 (24-hours post-injection), Visit 3 (48-hours post-injection), Visit 4 (72-hours post-injection), Visit 5 (Day 7), and Visit 6 (Day 14). Efficacy assessments (target lesion assessments, photography) and safety assessments will be conducted by the Investigator at each study visit. Subjects will conduct lesion pain assessments at each study visit as well as satisfaction assessments at each post-treatment visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
0.1mL of triamcinolone 1% solution per lesion
Center For Dermatology Clinical Research, Inc
Fremont, California, United States
Safety of intralesional triamcinolone injection
Adverse events and changes in concomitant medications
Time frame: 14 days
Target Lesion Erythema
A 5-point scale ranging from 0 (No Erythema) to 4 (Very Severe Erythema).
Time frame: 14 days
Target Lesion Severity
A 5-point scale ranging from 0 (None) to 4 (Very Severe)
Time frame: 14 days
Target Lesion Improvement
A 7-point scale ranging from 1 (Clear; 100%) to 7 (Worse)
Time frame: 14 days
Target Lesion Pain
0-10 Visual Analog Scale
Time frame: 14 days
Target Lesion Injection Pain
0-10 Visual Analog Scale
Time frame: Immediately after the injection of the first target lesion and at 5 minutes post-injection
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