NCT06170593

Intralesional Injections of Triamcinolone for Acne Vulgaris

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ACOM Labs · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Triamcinolone Injection	0.1mL of triamcinolone 1% solution per lesion

Timeline

• Start date: 2022-11-15
• Primary completion: 2023-01-31
• Completion: 2023-02-14
• First posted: 2023-12-14
• Last updated: 2023-12-14

Locations

1 site across 1 country: United States