Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Milton S. Hershey Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Lance Wood, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01159860
First received: July 9, 2010
Last updated: August 24, 2011
Last verified: June 2010
  Purpose

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 Intervention
Seborrheic Keratosis
Procedure: cryosurgery
Procedure: Curettage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Partial or complete resolution of treated lesion. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Lance Wood, Lance D. Wood, MD, Penn State Milton S. Hershey Medical Center, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01159860     History of Changes
Other Study ID Numbers: IRB Protocol No. 33895
Study First Received: July 9, 2010
Last Updated: August 24, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 01, 2014