intervention for Acne Vulgaris

N/A

Recruiting

Research Sponsored by ACOM Labs

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 14 days for reporting.

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 more

Awards & 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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