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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sebaceous Hyperplasia

Intervention / Treatment
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* Device: Erbium:YAG Laser
* Device: Pulsed Dye Laser
* Device: Nd:YAG Laser
* Procedure: Electrodessication and curettage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erbium:YAG Laser<br>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<br>* Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.<br>|
| Active Comparator: PDL plus Nd:YAG<br>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<br>* PDL will be performed using settings of 6-10 J/s2 on lesions.<br>* Other names: PDL;Device: Nd:YAG Laser<br>* Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.<br>|
| Active Comparator: ED&C treatment<br>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<br>* Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.<br>* Other names: ED&C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |