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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours - 14 days
Awards & highlights
No Placebo-Only Group
Summary
This trial wants to find out if it is safe and effective to use an injection assistance device to give yourself triamcinolone injections for acne. Participants will inject themselves with a small amount of tri
Who is the study for?
This trial is for individuals with acne who are interested in testing a new method of treatment. Participants will use an injection assistance device to self-administer triamcinolone into their acne lesions. Details on specific inclusion and exclusion criteria have not been provided.
What is being tested?
The study is examining the safety and effectiveness of using an injection assistance device to deliver triamcinolone directly into acne lesions. Participants will self-inject, then monitor and report the changes in their acne over a two-week period.
What are the potential side effects?
Potential side effects may include pain at the injection site, skin thinning or discoloration, increased risk of infection at the treated area, allergic reactions, or other local effects related to intralesional steroid injections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline - 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events following device use
Secondary study objectives
Subject satisfaction or dissatisfaction with treatment assessed via a 5-grade scale
Target Lesion Change
Target Lesion Change (subject)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: interventionExperimental Treatment1 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.
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Who is running the clinical trial?
ACOM LabsLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
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