Self-administered injections for treating acne

Patient Self-Administered Intralesional Injections of Triamcinolone for Acne Vulgaris

This study is testing whether people with acne can safely use a device to give themselves injections of medication directly into their pimples to see if it helps clear their skin.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ACOM Labs (industry)
• Locations: 3 sites (Fremont, California and 2 other locations)
• Trial ID: NCT06186596 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of self-administered intralesional injections of triamcinolone for treating acne vulgaris. Participants will use an injection assistance device to deliver the medication directly into acne lesions and will track their response through photos and surveys over a 14-day period. The study is open-label and will enroll approximately 150 subjects across three sites, with efficacy assessments conducted remotely by investigators based on submitted photos.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with facial acne vulgaris who have at least one inflammatory lesion suitable for treatment.

Not a fit: Patients who are pregnant, breastfeeding, or have a known hypersensitivity to triamcinolone may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a convenient and effective treatment option for patients suffering from acne vulgaris.

How similar studies have performed: While there is existing research on intralesional injections for acne, the self-administration aspect using an injection assistance device is a novel approach.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Diagnosed with facial acne vulgaris.
3. 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.
4. Owner of smartphone with capacity for front-facing photography and app download from Apple App Store or Google Play.
5. Able to follow study instructions and likely to comply with virtual follow-up requirements.
6. In good general health as determined by medical history at the time of screening (Investigator discretion).
7. Sign the IRB-approved ICF (including HIPAA authorization) prior to any study-related procedures being performed.

Exclusion Criteria:

1. Female subjects who are pregnant or breast-feeding.
2. Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection.
3. Active cutaneous viral infection in any treatment area at Baseline.
4. 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.
5. History of poor cooperation or unreliability (Investigator discretion).
6. Subjects who are investigational site staff members or family members of such employees.
7. Exposure to any other investigational device within 30 days prior to Visit 1.

Where this trial is running

Fremont, California and 2 other locations

• Center For Dermatology Clinical Research, Inc — Fremont, California, United States (RECRUITING)
• Skin Care Research — Boca Raton, Florida, United States (RECRUITING)
• Skin Care Research — Hollywood, Florida, United States (COMPLETED)

Study contacts

• Study coordinator: Lyra Olson, PhD

Conditions: Acne Vulgaris