Self-Administered Intralesional Injections for Acne
Status unconfirmed · Not applicable
Conditions studied: Acne Vulgaris
In brief
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.
Key facts
- Study ID
- NCT06186596
- Run by
- ACOM Labs
- People needed
- 150
- Starts
- 2023-02-01
- Expected to finish
- 2024-01-31
- Last updated by the study team
- 2024-01-02
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 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.
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).
- 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 (enrolling)
- Skin Care Research — Boca Raton, Florida, United States (enrolling)
- Skin Care Research — Hollywood, Florida, United States
Full record on ClinicalTrials.gov
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