Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2015-08-31
2016-12-31
Brief Summary
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This study is a pilot study designed to determine feasibility of these procedures.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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electrocautery
Blocks of subjects' lesions will be randomized 1:1 to receive electrocautery or 532 nm Nd:YAG laser. Prior to treatment with either electrocautery or 532nm Q-switched Nd:YAG laser, a topical EMLA cream will be applied to the lesions for at least 60 minutes under occlusion at the area of treatment.
Hyfrecator
532 nm Nd:YAG laser
Blocks of subjects' lesions will be randomized 1:1 to receive electrocautery or 532 nm Nd:YAG laser. Prior to treatment with either electrocautery or 532nm Q-switched Nd:YAG laser, a topical EMLA cream will be applied to the lesions for at least 60 minutes under occlusion at the area of treatment.
532 nm Q-switched Nd:YAG laser
Interventions
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Hyfrecator
532 nm Q-switched Nd:YAG laser
Eligibility Criteria
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Inclusion Criteria
2. Subjects who are between 18-65 year olds.
3. Subjects have flat or macular seborrheic keratosis on dorsum of the hands and wrists, extensor surfaces of the forearms. The diagnosis of flat seborrheic keratosis is confirmed by two clinical dermatologists using routine clinical examination and dermoscopy.
4. Subjects have Fitzpatrick skin type I-III.
5. Subjects are in good health.
6. Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.
Exclusion Criteria
2. Pregnant or lactating or intends to become pregnant in the next 3 months.
3. Active skin disease or skin infection in the treatment area.
4. Previous history of lidocaine allergy.
5. History of methemoglobinemia
6. Unable to understand the protocol or to give informed consent.
7. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study or would pose as an unacceptable risk to subject.
18 Years
65 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Murad Alam
Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Principal Investigators
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Murad Alam, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Countries
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Other Identifiers
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STU105340
Identifier Type: -
Identifier Source: org_study_id