Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone delivered via injection assistance device | Device | 0.1mL of 1% to 2% triamcinolone solution will be delivered to up to 3 facial inflammatory acne lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events following device use | Adverse events associated with device use for 14 days following injection | 14 days |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lyra Olson, PhD | Contact | 5142096452 | lolson@atomic.vc |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center For Dermatology Clinical Research, Inc | Recruiting | Fremont | California | 94538 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2023 | Dec 5, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2023 | Dec 5, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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.
| 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":
| 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
| 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
| baseline - 14 days |
| Target Lesion Change | Investigator will assess improvement of each target lesion on a 1 (100% clear) to 7 (worse) scale.
| 24 hours - 14 days |
| Skin Care Research | Recruiting | Boca Raton | Florida | 33486 | United States |
|
| Skin Care Research | Completed | Hollywood | Florida | 33021 | United States |