Electrocautery vs Q-switch for Seborrheic Keratosis

Keratosis, Seborrheic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02366559
• Other study ID #: STU105340
• Status: Withdrawn
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic
• Keratosis, Seborrheic

Intervention

Device:
• Hyfrecator

• 532 nm Q-switched Nd:YAG laser

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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