Treatment of Epidermoid Cysts
Primary Purpose
Epidermoid Cyst
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sodium Tetradecyl Sulfate
Sponsored by

About this trial
This is an interventional treatment trial for Epidermoid Cyst focused on measuring epidermoid, cyst, epidermoid cyst, small bumps beneath skin
Eligibility Criteria
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:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with 1.5% sodium tetradecyl sulfate foam
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Subject satisfaction rating
Extremely satisfied
Satisfied
Slightly satisfied
Slight dissatisfied
Dissatisfied
Extremely satisfied
Investigator skin irritation assessment (Draize scale)
Investigator skin irritation assessment (Draize scale) Score Erythema Edema
0 No erythema No Edema
Very slight Erythema very slight edema
Well-defined erythema Well-defined Edema
Moderate-to-severe erythema Moderate edema (raised approx 1mm)
Severe erythema (beet redness) Severe edema (raised greater than 1mm and extending beyond area of exposure)
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
Full Information
NCT ID
NCT05597995
First Posted
October 20, 2022
Last Updated
October 24, 2022
Sponsor
Goldman, Butterwick, Fitzpatrick and Groff
1. Study Identification
Unique Protocol Identification Number
NCT05597995
Brief Title
Treatment of Epidermoid Cysts
Official Title
A Prospective Clinical Trial Evaluating the Efficacy of 1.5% Sodium Tetradecyl Sulfate Foam Injection for the Treatment of Epidermoid Cysts
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Goldman, Butterwick, Fitzpatrick and Groff
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermoid Cyst
Keywords
epidermoid, cyst, epidermoid cyst, small bumps beneath skin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment with 1.5% sodium tetradecyl sulfate foam
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium Tetradecyl Sulfate
Other Intervention Name(s)
1.5% sodium tetradecyl sulfate foam
Intervention Description
subjects epidermoid cysts will be treated with 1.5% sodium tetradecyl sulfate foam
Primary Outcome Measure Information:
Title
Investigator Assessment of EIC (Epidermal inclusion cysts) resolution
Description
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
Title
Cyst wall destruction on histologic examination as determined by a board-certified dermatopathologist
Description
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
Secondary Outcome Measure Information:
Title
Subject satisfaction rating
Description
Extremely satisfied
Satisfied
Slightly satisfied
Slight dissatisfied
Dissatisfied
Extremely satisfied
Time Frame
Day 60
Title
Investigator skin irritation assessment (Draize scale)
Description
Investigator skin irritation assessment (Draize scale) Score Erythema Edema
0 No erythema No Edema
Very slight Erythema very slight edema
Well-defined erythema Well-defined Edema
Moderate-to-severe erythema Moderate edema (raised approx 1mm)
Severe erythema (beet redness) Severe edema (raised greater than 1mm and extending beyond area of exposure)
Time Frame
Baseline, Day 1, Day 7
Title
Subject injection site pain assessment on visual analog scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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).
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Pacheco
Phone
8586571004
Email
apacheco@clderm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sherif Mikhail, MD
Phone
8586571004
Email
smikhail@westderm.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Treatment of Epidermoid Cysts
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