Epidermoid CystPhase 2NCT05597995
Treatment of Epidermoid Cysts
A Phase 2 study testing Sodium Tetradecyl Sulfate in people with Epidermoid Cyst, run by Goldman, Butterwick, Fitzpatrick and Groff.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epidermoid Cyst
- What is being tested?
- Sodium Tetradecyl Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 30 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Clinical Trial Evaluating the Efficacy of 1.5% Sodium Tetradecyl Sulfate Foam Injection for the Treatment of Epidermoid Cysts
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.
Read the 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
- Being tested
- Sodium Tetradecyl Sulfate
- Keywords
- epidermoid, cyst, epidermoid cyst, small bumps beneath skin
- Medical subject headings
- Epidermal Cyst, Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Tetradecyl SulfateDrug
Also called 1.5% sodium tetradecyl sulfate foam
subjects epidermoid cysts will be treated with 1.5% sodium tetradecyl sulfate foam
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sodium Tetradecyl Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Day 60
Secondary outcomes (3)
Subject satisfaction rating
- Extremely satisfied
- Satisfied
- Slightly satisfied
- Slight dissatisfied
- Dissatisfied
- Extremely satisfied
Measured: Day 60
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)
Measured: Baseline, Day 1, Day 7
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
Measured: Baseline, Day 1, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermoid CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597995
- Sponsor's protocol ID
- EIC-STS
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Trial Evaluating the Efficacy of 1.5% Sodium Tetradecyl Sulfate Foam Injection for the Treatment of Epidermoid Cysts
- ClinicalTrials.gov ID
- NCT05597995
- Acronym / sponsor ID
- EIC-STS
- Conditions
- Epidermoid Cyst
- Keywords
- epidermoid, cyst, epidermoid cyst, small bumps beneath skin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment with 1.5% sodium tetradecyl sulfate foam | Experimental | Drug: Sodium Tetradecyl Sulfateeach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Tetradecyl SulfateAlso: 1.5% sodium tetradecyl sulfate foamsubjects epidermoid cysts will be treated with 1.5% sodium tetradecyl sulfate foam | Drug | Treatment with 1.5% sodium tetradecyl sulfate foam |
Primary outcome
Investigator Assessment of EIC (Epidermal inclusion cysts) resolution
Time frame: 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
Time frame: 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.
3 secondary outcomes
Subject satisfaction rating
Time frame: Day 60
Investigator skin irritation assessment (Draize scale)
Time frame: Baseline, Day 1, Day 7
Subject injection site pain assessment on visual analog scale
Time frame: Baseline, Day 1, Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Tetradecyl Sulfate in people with Epidermoid Cyst, run by Goldman, Butterwick, Fitzpatrick and Groff.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pacheco (8586571004, apacheco@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Assessment of EIC (Epidermal inclusion cysts) resolution (time frame: Day 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.