Electrocautery vs Q-switch for Seborrheic Keratosis

Comparing the Efficacy and Risk of Adverse Events of Electrocautery Versus 532 nm Qswitched Neodymium-doped Yttrium Aluminium Garnet Laser for the Treatment of Flat Seborrheic Keratoses: A Randomized Control Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Keratosis, Seborrheic
• Intervention / Treatment: Device: Hyfrecator; Device: 532 nm Q-switched Nd:YAG laser

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Hyfrecator
Active Comparator: 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.	Device: 532 nm Q-switched Nd:YAG laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pigmentation from baseline to week 18	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.	Baseline and 18 weeks
Change in lesion texture from baseline to week 18	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.	Baseline and 18 weeks

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: February 18, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Keratosis, Seborrheic
• Other Study ID Numbers: STU105340