Epidermal CystPhase 4NCT00165958
Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts
A Phase 4 study testing Excisional surgery of epidermal cyst and Punch incision of epidermal cyst in people with Epidermal Cyst, run by Emory University at 1 site in United States.
Trial summary
The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidermal Cyst
- What is being tested?
- Excisional surgery of epidermal cyst and Punch incision of epidermal cyst
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 years or older
- Epidermal cyst 1-3 cm in diameter on the trunk
Who cannot join
- Infected cyst requiring systemic antibiotics
- Pregnant females
- Unable to return to clinic for suture removal
- Previous excision of target cyst
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.
Read the detailed description
The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.
Patients with epidermal cysts will be randomized to having the cyst removed by surgical excision or by a smaller punch incision followed by removal of the cyst through the smaller hole. The skin will be stitched shut in both cases. A short survey about how the cyst affects the patient will be given before the cyst is removed. When the stitches are removed 2 weeks later, photographs will be taken and a survey regarding satisfaction with the procedure will be given. Two additional phone surveys, given at 4 and 12 months after the procedure, wil be given to ask about recurrence, satisfaction with the procedure, side effects, and how the cyst affected the patient's life. The study doctor will be blinded as to which procedure each subject underwent. Forty subjects will be recruited at the Atlanta Veteran's Administration Medical Center
- Conditions
- Epidermal Cyst
- Being tested
- Excisional surgery of epidermal cyst, Punch incision of epidermal cyst
- Keywords
- Epidermal cyst, Epidermoid cyst, Sebaceous cyst, Pilar cyst
- Medical subject headings
- Epidermal Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excisional surgery of epidermal cystProcedure or surgery
Traditional extirpation of cyst en toto
Punch incision of epidermal cystProcedure or surgery
removal of cyst first with incisional effort with a punch biopsy tool
| Study group | Role | What they receive |
|---|---|---|
| Punch excision | Experimental | Not described Receives: Procedure: Punch incision of epidermal cyst |
| Traditional excision | Active comparator | Not described Receives: Procedure: Excisional surgery of epidermal cyst |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Cyst Recurrence
Recurrence of cyst after removal
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2008
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epidermal CystStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suephy Chen, MD, Emory University
- Investigators
- Suephy C Chen, MD, Principal investigator, Emory University Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165958
- Sponsor's protocol ID
- 1023-2004
- Status last verified
- Jul 2014
- First submitted
- 12 Sep 2005
- Last updated
- 4 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts
- ClinicalTrials.gov ID
- NCT00165958
- Acronym / sponsor ID
- 1023-2004
- Conditions
- Epidermal Cyst
- Keywords
- Epidermal cyst, Epidermoid cyst, Sebaceous cyst, Pilar cyst
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Posted 4 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.
Detailed description
The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.
Patients with epidermal cysts will be randomized to having the cyst removed by surgical excision or by a smaller punch incision followed by removal of the cyst through the smaller hole. The skin will be stitched shut in both cases. A short survey about how the cyst affects the patient will be given before the cyst is removed. When the stitches are removed 2 weeks later, photographs will be taken and a survey regarding satisfaction with the procedure will be given. Two additional phone surveys, given at 4 and 12 months after the procedure, wil be given to ask about recurrence, satisfaction with the procedure, side effects, and how the cyst affected the patient's life. The study doctor will be blinded as to which procedure each subject underwent. Forty subjects will be recruited at the Atlanta Veteran's Administration Medical Center
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Punch excision | Experimental | Procedure: Punch incision of epidermal cyst |
| Traditional excision | Active comparator | Procedure: Excisional surgery of epidermal cyst |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult 18 years or older
- Epidermal cyst 1-3 cm in diameter on the trunk
Key exclusion criteria (4 listed)
- Infected cyst requiring systemic antibiotics
- Pregnant females
- Unable to return to clinic for suture removal
- Previous excision of target cyst
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 |
|---|---|---|
| Excisional surgery of epidermal cystTraditional extirpation of cyst en toto | Procedure or surgery | Traditional excision |
| Punch incision of epidermal cystremoval of cyst first with incisional effort with a punch biopsy tool | Procedure or surgery | Punch excision |
Primary outcome
Number of Participants With Cyst Recurrence
Time frame: 16 months
Recurrence of cyst after removal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Suephy C Chen, MD principal investigator
Emory University Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Excisional surgery of epidermal cyst and Punch incision of epidermal cyst in people with Epidermal Cyst, run by Emory University at 1 site in United States.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Cyst Recurrence (time frame: 16 months). 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 4 Aug 2014.