Acne Vulgaris
Conditions
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.
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.
Interventions
DEVICETriamcinolone delivered via injection assistance device
0.1mL of 1% to 2% triamcinolone solution will be delivered to up to 3 facial inflammatory acne lesions
Sponsors
ACOM Labs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events following device use | 14 days | Adverse events associated with device use for 14 days following injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Injection Pain | baseline and 5 min following injection | 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. |
| Target Lesion Change (subject) | 24 hours - 14 days | 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 |
| Target Lesion Severity | baseline - 14 days | Investigator will assess severity of each target lesion on a 0 (none) to 4 (very severe) scale. 0: None 1. Mild 2. Moderate 3. Severe 4. Very Severe |
| Target Lesion Pain | 14 days | 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. |
| Target Lesion Erythema | baseline - 14 days | Investigator will assess severity of erythema for each target lesion on a 0 (no erythema) to 4 (very severe erythema) scale. 0: No Erythema 1. Mild Erythema 2. Moderate Erythema 3. Severe Erythema 4. Very Severe Erythema |
| Target Lesion Change | 24 hours - 14 days | Investigator will assess improvement of each target lesion on a 1 (100% clear) to 7 (worse) scale. 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 |
| Subject satisfaction or dissatisfaction with treatment assessed via a 5-grade scale | 24 hours - 14 days | 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 |
Countries
United States
Contacts
Primary ContactLyra Olson, PhD
Outcome results
None listed