Recruiting

Self-Administered Injections

Sponsor:

ACOM Labs

Code:

NCT06186596

Conditions

Acne Vulgaris

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Triamcinolone delivered via injection assistance device

Study Details

Brief summary:

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.

Conditions

Acne Vulgaris

Study ID

NCT06186596

Start date

Feb 1, 2023

Status verified date

Dec, 2023

Completion date

Jan 31, 2024

Anticipated

Primary completion date

Jan 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Triamcinolone delivered via injection assistance device

0.1mL of 1% to 2% triamcinolone solution will be delivered to up to 3 facial inflammatory acne lesions

Primary outcome measure

  • Incidence of adverse events following device use [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Locations

Center For Dermatology Clinical Research, Inc

Recruiting

Fremont, California, United States, 94538

Skin Care Research

Recruiting

Boca Raton, Florida, United States, 33486

More Information

Sponsor

ACOM Labs

Last update posted

Jan 2, 2024

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ACOM Labs on 2024-01-02.