NCT00165958

Brief 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. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

August 4, 2014

Completed
Last Updated

August 4, 2014

Status Verified

July 1, 2014

Enrollment Period

3.5 years

First QC Date

September 12, 2005

Results QC Date

July 17, 2013

Last Update Submit

July 11, 2014

Conditions

Epidermal Cyst

Keywords

Epidermal cystEpidermoid cystSebaceous cystPilar cyst

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Cyst Recurrence

    Recurrence of cyst after removal

    16 months

Study Arms (2)

Punch excision

EXPERIMENTAL
Procedure: Punch incision of epidermal cyst

Traditional excision

ACTIVE COMPARATOR
Procedure: Excisional surgery of epidermal cyst

Interventions

Excisional surgery of epidermal cystPROCEDURE

Traditional extirpation of cyst en toto

Traditional excision
Punch incision of epidermal cystPROCEDURE

removal of cyst first with incisional effort with a punch biopsy tool

Punch excision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult 18 years or older
  • Epidermal cyst 1-3 cm in diameter on the trunk

You may not qualify if:

  • Infected cyst requiring systemic antibiotics
  • Pregnant females
  • Unable to return to clinic for suture removal
  • Previous excision of target cyst

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical Center

Decatur, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Epidermal Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasms

Limitations and Caveats

The limitations of this study include the small, predominately male patient population, lack of complete follow-up of secondary endpoint measurements at every time point.

Results Point of Contact

Title
Dr. Suephy Chen
Organization
Emory University
schen2@emory.edu
4047783084

Study Officials

  • Suephy C Chen, MD

    Emory University Department of Dermatology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

January 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2011

Last Updated

August 4, 2014

Results First Posted

August 4, 2014

Record last verified: 2014-07

Locations

US(1)