Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?

NCT ID: NCT01159860

Last Updated: 2018-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-06-06

Brief Summary

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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.

Detailed Description

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Conditions

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Seborrheic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Cryosurgery

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

Group Type ACTIVE_COMPARATOR

cryosurgery

Intervention Type PROCEDURE

freezing of lesion with liquid nitrogen

Curettage

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

Group Type ACTIVE_COMPARATOR

Curettage

Intervention Type PROCEDURE

the lesion will be anesthetized and destroyed with a curette.

Interventions

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cryosurgery

freezing of lesion with liquid nitrogen

Intervention Type PROCEDURE

Curettage

the lesion will be anesthetized and destroyed with a curette.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lance D. Wood, M.D.

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19465852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15090020 (View on PubMed)

Other Identifiers

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IRB Protocol No. 33895

Identifier Type: -

Identifier Source: org_study_id

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