Self-Administered Intralesional Injections for Acne

Patient Self-Administered Intralesional Injections of Triamcinolone for Acne Vulgaris

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.

Study Overview

• Status: Recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Device: Triamcinolone delivered via injection assistance device

Detailed Description

This is an open-label, prospective, single-arm study. Approximately 150 subjects will be enrolled at approximately 3 study sites.

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.

Efficacy assessments (target lesion assessments) will be conducted remotely by the Investigator at time of each photo submission. Subjects will conduct lesion pain assessments and satisfaction assessments at the time of each remote check-in. Participants will be invited to also have additional photography captured by the study team at the study site or at a location as per participants' convenience.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lyra Olson, PhD; Phone Number: 5142096452; Email: lolson@atomic.vc

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Recruiting
      • CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc
      • Contact: Coordinator
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Recruiting
      • Skin Care Research
      • Contact: Coordinator
    • Hollywood, Florida, United States, 33021
      • Completed
      • Skin Care Research

Participation Criteria

Eligibility Criteria

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

Description

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 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: 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.

Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events following device use	Adverse events associated with device use for 14 days following injection	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Pain	For each inflammatory lesion injected, lesion pain will be assessed by the subject 0 to 10 scale, where 0 is no pain and 10 is worst imaginable pain. Lesion pain at Baseline will be recorded prior to injection(s). The occurrence of inflammatory lesion pain is expected and will not be considered an AE.	14 days
Target Lesion Injection Pain	Injection Site Pain during injection will be assessed immediately after the injection of the first target lesion and at 5 minutes post-injection. The occurrence of injection site pain is expected and will not be considered an AE. For each inflammatory lesion injected, lesion pain will be assessed by the subject 0 to 10 scale, where 0 is no pain and 10 is worst imaginable pain.	baseline and 5 min following injection
Target Lesion Change (subject)	The subject will assess subjective improvement seen with each target lesion compared to Baseline.; Clear (100%); Almost clear (90% to <100%); Marked improvement (75% to <90%); Moderate improvement (50% to <75%); Fair improvement (25% to <50%); No change; Worse	24 hours - 14 days
Subject satisfaction or dissatisfaction with treatment assessed via a 5-grade scale	Satisfaction or dissatisfaction with will be assessed by the subject using the following subjective 5-grade scale as detailed below. Subject will be instructed: "Rate your level of satisfaction with the effect of study treatment on inflammatory acne lesions by using the following scale": Very satisfied; Satisfied; Neither satisfied nor dissatisfied; Dissatisfied; Very dissatisfied	24 hours - 14 days
Target Lesion Erythema	Investigator will assess severity of erythema for each target lesion on a 0 (no erythema) to 4 (very severe erythema) scale. 0: No Erythema; Mild Erythema; Moderate Erythema; Severe Erythema; Very Severe Erythema	baseline - 14 days
Target Lesion Severity	Investigator will assess severity of each target lesion on a 0 (none) to 4 (very severe) scale. 0: None; Mild; Moderate; Severe; Very Severe	baseline - 14 days
Target Lesion Change	Investigator will assess improvement of each target lesion on a 1 (100% clear) to 7 (worse) scale.; Clear (100%); Almost clear (90% to <100%); Marked improvement (75% to <90%); Moderate improvement (50% to <75%); Fair improvement (25% to <50%); No change; Worse	24 hours - 14 days

Collaborators and Investigators

• Sponsor: ACOM Labs

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Estimated): January 1, 2024

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 15, 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-2301

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