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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2025

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Erbium:YAG Laser
    • 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.
  • Active Comparator: PDL plus Nd:YAG
    • 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.
  • Active Comparator: ED&C treatment
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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

Participating in This Clinical Trial

Inclusion Criteria

1. ≥18 years of age 2. Receiving cosmetic treatment for sebaceous hyperplasia 3. In good general health as assessed by the investigator 4. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study Exclusion Criteria:

1. Patient pregnant or nursing 2. Patient with history of poor wound healing that would result in hypertrophic scar or keloid at the discretion of the physician 3. Patient with recent sun exposure that would result in pigment changes at the discretion of the physician 4. Subject unwilling to sign an IRB approved consent form 5. 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Northwestern University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Murad Alam, Professor of Dermatology – Northwestern University
  • Overall Official(s)
    • Murad Alam, MD, Principal Investigator, Northwestern University
  • Overall Contact(s)
    • DermCTU, 3126958106, NUderm-research@northwestern.edu

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