Clinical trial NCT06170593: Intralesional Injections of Triamcinolone for Acne Vulgaris
Official title: Intralesional Injections of Triamcinolone for Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: ACOM Labs
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This proof-of-concept study seeks to investigate the safety of intralesional injections of triamcinolone for acne vulgaris lesions using an Intradermal Needle Adapter.

Detailed description: This is an open-label, prospective, single-arm study. Approximately 20 subjects will be enrolled at 1 study site.

All subjects will receive treatment with the study protocol (i.e., intralesional injection with triamcinolone) at Visit 1 (Day 1). Subjects will then attend in-clinic visits at Visit 2 (24-hours post-injection), Visit 3 (48-hours post-injection), Visit 4 (72-hours post-injection), Visit 5 (Day 7), and Visit 6 (Day 14).

Efficacy assessments (target lesion assessments, photography) and safety assessments will be conducted by the Investigator at each study visit. Subjects will conduct lesion pain assessments at each study visit as well as satisfaction assessments at each post-treatment visit.

Eligibility criteria: Inclusion Criteria:

* Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline.
* Diagnosed with facial acne vulgaris.
* At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is amenable to intralesional injection of triamcinolone.
* Able to follow study instructions and likely to complete all required visits.
* In good general health as determined by medical history at the time of screening (Investigator discretion).
* Sign the IRB-approved informed consent form (including HIPAA authorization) prior to any study-related procedures being performed

Exclusion Criteria:

* Female subjects who are pregnant or breast-feeding.
* Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection.
* Active cutaneous viral infection in any treatment area at Baseline.
* 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.
* History of poor cooperation or unreliability (Investigator discretion).
* Planning to move out of the area prior to study completion.
* Subjects who are investigational site staff members or family members of such employees.
* Exposure to any other investigational /device within 30 days prior to Visit 1.

Primary outcomes:
measure: Safety of intralesional triamcinolone injection
timeFrame: 14 days
Secondary outcomes:
measure: Target Lesion Erythema
timeFrame: 14 days
measure: Target Lesion Severity
timeFrame: 14 days
measure: Target Lesion Improvement
timeFrame: 14 days
measure: Target Lesion Pain
timeFrame: 14 days
measure: Target Lesion Injection Pain
timeFrame: Immediately after the injection of the first target lesion and at 5 minutes post-injection
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc
state: California
Study officials:
References: