Intralesional Injections of Triamcinolone for Acne Vulgaris (ATM-2201)

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Triamcinolone Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Participants will receive injections of 1% triamcinolone into at least 1 and up to 3 facial inflammatory acne lesions. Participants will return to clinic at 24, 48, 72 hours, 7 days, and 14 days following injection for follow up assessment and photography.	Drug: Triamcinolone Injection; 0.1mL of triamcinolone 1% solution per lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of intralesional triamcinolone injection	Adverse events and changes in concomitant medications	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Erythema	A 5-point scale ranging from 0 (No Erythema) to 4 (Very Severe Erythema).	14 days
Target Lesion Severity	A 5-point scale ranging from 0 (None) to 4 (Very Severe)	14 days
Target Lesion Improvement	A 7-point scale ranging from 1 (Clear; 100%) to 7 (Worse)	14 days
Target Lesion Pain	0-10 Visual Analog Scale	14 days
Target Lesion Injection Pain	0-10 Visual Analog Scale	Immediately after the injection of the first target lesion and at 5 minutes post-injection

Collaborators and Investigators

• Sponsor: ACOM Labs

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): February 14, 2023

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Estimated): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone
• Other Study ID Numbers: ATM-2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No