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

NCT04429607 | Not Yet Recruiting Phase 2 FDA Device

• 1 other identifier: STU00211739
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in size of sebaceous hyperplasia

  Change in size of sebaceous hyperplasia from baseline to 4-12 weeks after first treatment by measuring length and width in mm of each lesion.

  4-12 weeks

• Change in sebaceous hyperplasia lesion count

  Change in sebaceous hyperplasia lesion count from baseline to 4-12 weeks after first treatment

  4-12 weeks

Study Arms (3)

Erbium:YAG Laser

ACTIVE COMPARATOR

Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.

Device: Erbium:YAG Laser

PDL plus Nd:YAG

ACTIVE COMPARATOR

Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.

Device: Pulsed Dye Laser; Device: Nd:YAG Laser

ED&C treatment

ACTIVE COMPARATOR

Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.

Procedure: Electrodessication and curettage

Interventions

Erbium:YAG Laser DEVICE

Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.

Erbium:YAG Laser

Pulsed Dye Laser DEVICE

PDL will be performed using settings of 6-10 J/s2 on lesions.

Also known as: PDL

PDL plus Nd:YAG

Nd:YAG Laser DEVICE

Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.

PDL plus Nd:YAG

Electrodessication and curettage PROCEDURE

Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.

Also known as: ED&C

ED&C treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Receiving cosmetic treatment for sebaceous hyperplasia
• In good general health as assessed by the investigator
• Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

You may not qualify if:

• Patient pregnant or nursing
• Patient with history of poor wound healing that would result in hypertrophic scar or keloid at the discretion of the physician
• Patient with recent sun exposure that would result in pigment changes at the discretion of the physician
• Subject unwilling to sign an IRB approved consent form
• Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Lasers, Dye; Curettage

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Surgical Procedures, Operative

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DermCTU

CONTACT

3126958106; NUderm-research@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)