Back to resultsIs Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?
Primary Purpose
Seborrheic Keratosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cryosurgery
Curettage
Sponsored by
About this trial
This is an interventional treatment trial for Seborrheic Keratosis focused on measuring seborrheic keratoses, cryosurgery, curettage
Eligibility Criteria
Inclusion Criteria:
- have at least 1 seborrheic keratosis on each side of his/her trunk or proximal extremities.
- be able to understand the consent form and evaluation of treatment questionnaire.
Exclusion Criteria:
- Children <18 are excluded from this study based on their inability to independently complete the informed consent and research associated questionnaire.
Sites / Locations
- Penn State Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cryosurgery
Curettage
Arm Description
One lesion on the patients' trunk or proximal extremities will be treated with cryosurgery.
One lesion on one side of the patients' trunk or proximal extremities will be treated by curettage.
Outcomes
Primary Outcome Measures
Partial or complete resolution of treated lesion.
Follow up evaluation by a blinded physician along with the gathering of patient information via questionnaires will be obtained at the completion of the study.
Secondary Outcome Measures
Full Information
NCT ID
NCT01159860
First Posted
July 9, 2010
Last Updated
May 23, 2018
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01159860
Brief Title
Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?
Official Title
Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 11, 2012 (Actual)
Study Completion Date
June 6, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Seborrheic keratoses (SK's) are very common, but harmless skin lesions that commonly appear during adult life. Patients with seborrheic keratoses frequently desire treatment due to symptoms of itching and irritation or for cosmetic purposes. Seborrheic keratoses can be easily removed and have been treated in a number of different ways. Two of the simplest and most successful ways to remove seborrheic keratoses are cryosurgery and curettage.
The investigators are conducting this study to see which of these two treatments has the best result.
Approximately 24-30 people will take part in this research study at the Hershey Medical Center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Keratosis
Keywords
seborrheic keratoses, cryosurgery, curettage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryosurgery
Arm Type
Active Comparator
Arm Description
One lesion on the patients' trunk or proximal extremities will be treated with cryosurgery.
Arm Title
Curettage
Arm Type
Active Comparator
Arm Description
One lesion on one side of the patients' trunk or proximal extremities will be treated by curettage.
Intervention Type
Procedure
Intervention Name(s)
cryosurgery
Intervention Description
freezing of lesion with liquid nitrogen
Intervention Type
Procedure
Intervention Name(s)
Curettage
Intervention Description
the lesion will be anesthetized and destroyed with a curette.
Primary Outcome Measure Information:
Title
Partial or complete resolution of treated lesion.
Description
Follow up evaluation by a blinded physician along with the gathering of patient information via questionnaires will be obtained at the completion of the study.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
have at least 1 seborrheic keratosis on each side of his/her trunk or proximal extremities.
be able to understand the consent form and evaluation of treatment questionnaire.
Exclusion Criteria:
Children <18 are excluded from this study based on their inability to independently complete the informed consent and research associated questionnaire.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance D. Wood, M.D.
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19465852
Citation
Brodsky J. Management of benign skin lesions commonly affecting the face: actinic keratosis, seborrheic keratosis, and rosacea. Curr Opin Otolaryngol Head Neck Surg. 2009 Aug;17(4):315-20. doi: 10.1097/MOO.0b013e32832d75e3.
Results Reference
background
PubMed Identifier
15090020
Citation
Herron MD, Bowen AR, Krueger GG. Seborrheic keratoses: a study comparing the standard cryosurgery with topical calcipotriene, topical tazarotene, and topical imiquimod. Int J Dermatol. 2004 Apr;43(4):300-2. doi: 10.1111/j.1365-4632.2004.02282.x.
Results Reference
background
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Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?
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