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Clinical Trial 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.


Clinical Trial 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 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 Design


Related Conditions & MeSH terms


NCT number NCT06170593
Study type Interventional
Source ACOM Labs
Contact
Status Completed
Phase N/A
Start date November 15, 2022
Completion date February 14, 2023

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