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Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?

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ClinicalTrials.gov Identifier: NCT01159860
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

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.


Condition or disease Intervention/treatment Phase
Seborrheic Keratosis Procedure: cryosurgery Procedure: Curettage Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?
Study Start Date : July 2010
Actual Primary Completion Date : May 11, 2012
Actual Study Completion Date : June 6, 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Cryosurgery
One lesion on the patients' trunk or proximal extremities will be treated with cryosurgery.
Procedure: 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.
Procedure: Curettage
the lesion will be anesthetized and destroyed with a curette.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159860


Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Lance D. Wood, M.D. Milton S. Hershey Medical Center

Publications:
Responsible Party: Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01159860     History of Changes
Other Study ID Numbers: IRB Protocol No. 33895
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Keywords provided by Milton S. Hershey Medical Center:
seborrheic keratoses
cryosurgery
curettage

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Keratosis, Seborrheic
Skin Diseases
Precancerous Conditions
Neoplasms