Treatment of Epidermoid Cysts

NCT05597995 | Unknown Phase 2 FDA Drug

• 1 other identifier: EIC-STS
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Epidermoid Cyst

Keywords

epidermoid; cyst; epidermoid cyst; small bumps beneath skin

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Drug: Sodium Tetradecyl Sulfate

Interventions

Sodium Tetradecyl Sulfate DRUG

subjects epidermoid cysts will be treated with 1.5% sodium tetradecyl sulfate foam

Also known as: 1.5% sodium tetradecyl sulfate foam

Treatment with 1.5% sodium tetradecyl sulfate foam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
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• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead

MeSH Terms

Conditions

Epidermal Cyst; Cysts

Interventions

Sodium Tetradecyl Sulfate

Condition Hierarchy (Ancestors)

Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Alcohols; Alcohols; Organic Chemicals; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids

Central Study Contacts

Andrea Pacheco

CONTACT

8586571004; apacheco@clderm.com

Sherif Mikhail, MD

CONTACT

8586571004; smikhail@westderm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: October 20, 2022
• First Posted: October 28, 2022
• Study Start: November 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: October 28, 2022

Record last verified: 2022-10