What this study is
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.
What's being tested
- Erbium:YAG Laser
Intervention · DEVICE
Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.
- Pulsed Dye Laser
Intervention · DEVICE
PDL will be performed using settings of 6-10 J/s2 on lesions.
- Nd:YAG Laser
Intervention · DEVICE
Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.
- Electrodessication and curettage
Intervention · PROCEDURE
Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.
Study details
- Sponsor
- Northwestern University
- Conditions
- Sebaceous Hyperplasia
- Enrolling
- 18 people
- Starts
- 2025-10-23
- Est. completion
- 2026-12
- Design
- Single-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNorthwestern University Department of Dermatology
Chicago, Illinois, United States
Study team
Sponsor
Northwestern University
Study ID STU00211739
Principal investigator
Murad Alam, MD
Northwestern University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.