Self-Administered Intralesional Injections for Acne

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: ACOM Labs

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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 Criteria

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.

Inclusion Criteria

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

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)

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Exclusion Criteria

Subjects who are investigational site staff members or family members of such employees

Female subjects who are pregnant or breast-feeding

Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection

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Treatment Details

Interventions

Triamcinolone (Corticosteroid)

Trial OverviewThe 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.

Participant Groups

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.

Triamcinolone is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Kenalog for: