NCT05597995

Treatment of Epidermoid Cysts

A Prospective Clinical Trial Evaluating the Efficacy of 1.5% Sodium Tetradecyl Sulfate Foam Injection for the Treatment of Epidermoid Cysts

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Epidermoid Cyst

Interventions

Type	Name	Description
DRUG	Sodium Tetradecyl Sulfate	subjects epidermoid cysts will be treated with 1.5% sodium tetradecyl sulfate foam

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2022-10-28
• Last updated: 2022-10-28

Regulatory

• FDA-regulated drug study