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The objective of this study is to determine the efficacy, safety, tolerability, and patient satisfaction associated with the treatment of epidermoid cysts with injected 1.5% sodium tetradecyl sulfate (STS) foam.
The primary objective is to determine the efficacy of STS foam injection on EIC with an endpoint of clinical resolution and cyst wall destruction on histology.
Enrolled subjects will undergo aspiration of cyst contents through an 18g needle immediately followed by injection of 1.5% STS foam (until the cyst is full and foam is flowing out of the injection site) followed by surgical excision 60 days later. The foam will be created by diluting 3% STS with an equal volume of normal saline then mixing with air in a 1:4 ratio using a female-to-female coupler.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with 1.5% sodium tetradecyl sulfate foam | Experimental | each subject will have cyst contents aspirated through an 18g needle followed by an injection of 1.5% STS solution foamed 1:4 with air until foam is flowing out of the injection site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Tetradecyl Sulfate | Drug | subjects epidermoid cysts will be treated with 1.5% sodium tetradecyl sulfate foam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessment of EIC (Epidermal inclusion cysts) resolution | Investigator Assessment of EIC (Epidermal inclusion cysts) resolution or recurrence Did the cyst resolve (involution or substantial decrease in size and clinical appearance)? (circle one) Resolved Did not resolve | Day 60 |
| Cyst wall destruction on histologic examination as determined by a board-certified dermatopathologist | A dermatopathologist will examine the excised cysts to determine if the cyst lining was damaged by injection of STS foam, as demonstrated by the presence of necrotic squamous epithelium. | Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject satisfaction rating |
| Day 60 |
| Investigator skin irritation assessment (Draize scale) |
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Inclusion Criteria:
Adults in good general health based on the investigator's judgment and medical history aged 18-80 years old
Must be willing to sign a photography release and ICF.
Subject must be willing to undergo study procedures, including STS foam injection and excision with simple closure with an expected linear scar.
Epidermal inclusion cyst on the skin (not on mucosa or genitals) at least 4 mm in size
Negative urine pregnancy test at the time of study entry (if applicable)
Females will be either of non-childbearing potential defined as:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pacheco | Contact | 8586571004 | apacheco@clderm.com | |
| Sherif Mikhail, MD | Contact | 8586571004 | smikhail@westderm.com |
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| ID | Term |
|---|---|
| D004814 | Epidermal Cyst |
| D003560 | Cysts |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012981 | Sodium Tetradecyl Sulfate |
| ID | Term |
|---|---|
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000476 | Alkanesulfonates |
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Enrolled subjects will undergo aspiration of cyst contents through an 18g needle immediately followed by injection of 1.5% STS foam (until the cyst is full and foam is flowing out of the injection site) followed by surgical excision 60 days later. The foam will be created by diluting 3% STS with an equal volume of normal saline then mixing with air in a 1:4 ratio using a female-to-female coupler.
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|
Investigator skin irritation assessment (Draize scale) Score Erythema Edema
0 No erythema No Edema
| Baseline, Day 1, Day 7 |
| Subject injection site pain assessment on visual analog scale | Visual Analog Scale Rate your pain on a scale of 1 to 10 ( circle one) 1 2 3 4 5 6 7 8 9 10 | Baseline, Day 1, Day 7 |
| D017738 |
| Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008055 | Lipids |