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Treatment of Epidermoid Cysts

Primary Purpose

Epidermoid Cyst

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Sodium Tetradecyl Sulfate

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:
1. Having no uterus
2. 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:
1. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
2. Intrauterine coil
3. Bilateral tubal ligation
4. Hysterectomy
5. Barrier method used with an additional form of contraception (e.g., sponge, spermicide, or condom)
6. Abstinence (If practicing abstinence, must agree to use a barrier method described above (4) If they become sexually active).
7. 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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

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

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

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

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

apacheco@clderm.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sherif Mikhail, MD

Phone

8586571004

smikhail@westderm.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Treatment of Epidermoid Cysts

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