NCT04429607

Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare treatment of sebaceous hyperplasia with pulsed dye laser (PDL) plus neodymium doped yttrium aluminum garnet laser (Nd:YAG) versus erbium doped yttrium aluminum garnet (erbium:YAG) laser versus electrodesiccation and curettage (ED\&C). This is a randomized clinical trial. Approximately 18 participants will enrolled. Each participant will have their sebaceous hyperplasia lesions randomized to receive either Erbium:YAG, PDL plus Nd:YAG, or ED\&C treatment. Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Lesions will be treated twice, 2-6 weeks after the first treatment. Lesion size and count will be measured before treatment and at follow-up 4-12 weeks after the first treatment. This study is a pilot study designed to determine the feasibility of these procedures. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

Conditions

• Sebaceous Hyperplasia

Interventions

Type	Name	Description
DEVICE	Erbium:YAG Laser	Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.
DEVICE	Pulsed Dye Laser	PDL will be performed using settings of 6-10 J/s2 on lesions.
DEVICE	Nd:YAG Laser	Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.
PROCEDURE	Electrodessication and curettage	Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2020-06-12
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study