NCT01159860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2013

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

July 9, 2010

Last Update Submit

May 23, 2018

Conditions

Seborrheic Keratosis

Keywords

seborrheic keratosescryosurgerycurettage

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Cryosurgery

ACTIVE COMPARATOR

One lesion on the patients' trunk or proximal extremities will be treated with cryosurgery.

Procedure: cryosurgery

Curettage

ACTIVE COMPARATOR

One lesion on one side of the patients' trunk or proximal extremities will be treated by curettage.

Procedure: Curettage

Interventions

cryosurgeryPROCEDURE

freezing of lesion with liquid nitrogen

Cryosurgery
CurettagePROCEDURE

the lesion will be anesthetized and destroyed with a curette.

Curettage

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Children \<18 are excluded from this study based on their inability to independently complete the informed consent and research associated questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related 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.

    PMID: 19465852BACKGROUND

  • 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.

    PMID: 15090020BACKGROUND

MeSH Terms

Conditions

Keratosis, Seborrheic

Interventions

CryosurgeryCurettage

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Lance D. Wood, M.D.

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2010

First Posted

July 12, 2010

Study Start

July 1, 2010

Primary Completion

May 11, 2012

Study Completion

June 6, 2013

Last Updated

May 25, 2018

Record last verified: 2018-05

Locations

US(1)