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

Conditions

• Sebaceous Hyperplasia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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.
• 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.

Study Details

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.

Key Dates

First listed

Jun 12, 2020

Start date

Oct 23, 2025

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

18 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Change in size of sebaceous hyperplasia [ Time Frame: 4-12 weeks ]

Locations (1)

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