- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01159860
Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State Milton S. Hershey Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cryosurgery
One lesion on the patients' trunk or proximal extremities will be treated with cryosurgery.
|
freezing of lesion with liquid nitrogen
|
Active Comparator: Curettage
One lesion on one side of the patients' trunk or proximal extremities will be treated by curettage.
|
the lesion will be anesthetized and destroyed with a curette.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Partial or complete resolution of treated lesion.
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lance D. Wood, M.D., Milton S. Hershey Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB Protocol No. 33895
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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