Self-Administered Intralesional Injections for Acne

ACOM Labs150 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Acne Vulgaris

Interventions

Triamcinolone delivered via injection assistance deviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

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

Outcomes

Primary Outcomes

Incidence of adverse events following device use

Adverse events associated with device use for 14 days following injection

Time frame: 14 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: baseline and 5 min following injection

Target Lesion Change (subject)

The subject will assess subjective improvement seen with each target lesion compared to Baseline. 1. Clear (100%) 2. Almost clear (90% to \<100%) 3. Marked improvement (75% to \<90%) 4. Moderate improvement (50% to \<75%) 5. Fair improvement (25% to \<50%) 6. No change 7. Worse

Time frame: 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": 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied

Central Contacts

Lyra Olson, PhD

CONTACT

5142096452 lolson@atomic.vc

Data from ClinicalTrials.gov

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