Patient Self-Administered Intralesional Injections of Triamcinolone for Acne Vulgaris

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to test the safety of intralesional injections of triamcinolone self-administered into acne lesions via an injection assistance device. The main question\[s\] it aims to answer are: * is use of the injection assistance device safe? * is delivery of triamcinolone to acne lesions via the injection assistance device efficacious? Participants will self-inject low dose triamcinolone into acne lesions and track lesion response via photos and survey for 14 days following injection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative UPT at Baseline.

• Diagnosed with facial acne vulgaris.

• At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is clinically indicated for standard-of-care intralesional injection(s) of triamcinolone.

• Owner of smartphone with capacity for front-facing photography and app download from Apple App Store or Google Play.

• Able to follow study instructions and likely to comply with virtual follow-up requirements.

• In good general health as determined by medical history at the time of screening (Investigator discretion).

• Sign the IRB-approved ICF (including HIPAA authorization) prior to any study-related procedures being performed.

Locations
United States
California
Center For Dermatology Clinical Research, Inc
RECRUITING
Fremont
Florida
Skin Care Research
RECRUITING
Boca Raton
Skin Care Research
COMPLETED
Hollywood
Contact Information
Primary
Lyra Olson, PhD
lolson@atomic.vc
5142096452
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2024-01-31
Participants
Target number of participants: 150
Treatments
Experimental: intervention
All subjects will receive standard-of-care intralesional injection with triamcinolone using an Injection Assistance Device (i.e., for self-administered intralesional injections) at Visit 1 (Day 1). Subjects will then submit photos via secure photographic app for asynchronous follow up on Day 2 (24-hours post-injection), Day 3 (48-hours post-injection), Day 4 (72-hours post-injection), Day 7, and Day 14.
Related Therapeutic Areas
Sponsors
Leads: ACOM Labs

This content was sourced from clinicaltrials.gov