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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01159860
Other study ID # IRB Protocol No. 33895
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2010
Est. completion date June 6, 2013

Study information

Verified date May 2018
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date June 6, 2013
Est. primary completion date May 11, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Procedure:
cryosurgery
freezing of lesion with liquid nitrogen
Curettage
the lesion will be anesthetized and destroyed with a curette.

Locations

Country Name City State
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 weeks
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