A Prospective Clinical Trial Evaluating the Efficacy of 1.5% Sodium Tetradecyl Sulfate Foam Injection for the Treatment of Epidermoid Cysts
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Investigator Assessment of EIC (Epidermal inclusion cysts) resolution
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •Having no uterus
- •No menses for at least 12 months. Or; Female subjects of childbearing potential must agree to use an effective method of birth control during the course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation. Acceptable forms of birth control are below:
- •Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
- •Intrauterine coil
- •Bilateral tubal ligation
- •Hysterectomy
- •Barrier method used with an additional form of contraception (e.g., sponge, spermicide, or condom)
- •Abstinence (If practicing abstinence, must agree to use a barrier method described above (4) If they become sexually active).
- •Vasectomized (must agree to use barrier method described above (4) if they become sexually active with an un-vasectomized partner).
排除标准
- •Pregnancy or planned pregnancy during the study or currently breastfeeding.
- •Previously excised cysts or actively inflamed cysts will not be included in the study.
- •Presence of incompletely healed wound in the treatment area.
- •Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- •Significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- •Allergy to STS.
- •Active dermatitis, active bacterial, neurologic, fungal, or viral infection in the proposed treatment area.
- •Inability to ambulate following the procedure.
- •Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
研究组 & 干预措施
Treatment with 1.5% sodium tetradecyl sulfate foam
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.
干预措施: Sodium Tetradecyl Sulfate (Drug)
结局指标
主要结局
Investigator Assessment of EIC (Epidermal inclusion cysts) resolution
时间窗: Day 60
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
Cyst wall destruction on histologic examination as determined by a board-certified dermatopathologist
时间窗: Day 60
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.
次要结局
- Subject satisfaction rating(Day 60)
- Investigator skin irritation assessment (Draize scale)(Baseline, Day 1, Day 7)
- Subject injection site pain assessment on visual analog scale(Baseline, Day 1, Day 7)