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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
subjects epidermoid cysts will be treated with 1.5% sodium tetradecyl sulfate foam
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
Time frame: 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.
Time frame: Day 60
Subject satisfaction rating
1. Extremely satisfied 2. Satisfied 3. Slightly satisfied 4. Slight dissatisfied 5. Dissatisfied 6. Extremely satisfied
Time frame: Day 60
Investigator skin irritation assessment (Draize scale)
Investigator skin irritation assessment (Draize scale) Score Erythema Edema 0 No erythema No Edema 1. Very slight Erythema very slight edema 2. Well-defined erythema Well-defined Edema 3. Moderate-to-severe erythema Moderate edema (raised approx 1mm) 4. Severe erythema (beet redness) Severe edema (raised greater than 1mm and extending beyond area of exposure)
Time frame: 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
Time frame: Baseline, Day 1, Day 7
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