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OpenTrials
Enrolling by Invitation

NCT Number: NCT04429607

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

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.

Enrolling by Invitation

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Key information

Conditions

Sebaceous Hyperplasia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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

Treatment and study plan

Erbium:YAG Laser

Device

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

Pulsed dye laser

Device

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

Other names: PDL

Nd:Yag Laser

Device

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

Electrodessication and curettage

Procedure

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

Other names: ED&C

Primary outcomes

  1. Change in size of sebaceous hyperplasia

    Time frame: 4-12 weeks

    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.

  2. Change in sebaceous hyperplasia lesion count

    Time frame: 4-12 weeks

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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2020
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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