Electrocautery vs Q-switch for Seborrheic Keratosis

Not Applicable

Withdrawn

• Conditions: Keratosis, Seborrheic
• Interventions: Device: Hyfrecator

• Registration Number: NCT02366559
• Lead Sponsor: Northwestern University

Brief Summary

The primary objective of this study is to compare the efficacy and risk of adverse events of electrocautery versus 532 nm Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG) laser for the treatment of flat seborrheic keratoses.

This study is a pilot study designed to determine feasibility of these procedures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-18
• Study First Posted: 2015-02-19
• Study Start: 2015-08
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects are Caucasian or Asian.
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.

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Exclusion Criteria

1. History of keloids or hypertrophic scars.
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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electrocautery	Hyfrecator	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.

Primary Outcome Measures

Name	Time	Method
Change in lesion texture from baseline to week 18	Baseline and 18 weeks	Blinded photo raters will the lesion texture on a scale of -50 (most worsening relative to baseline) to +50 (most improvement relative to baseline) for both treatments.
Change in Pigmentation from baseline to week 18	Baseline and 18 weeks	Blinded photo raters will the lesion pigmentation on a scale of -50 (most hypopigmented relative to baseline) to +50 (most hyperpigmented relative to baseline) for both treatments.