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

Phase 2Not Yet RecruitingNCT04429607

Northwestern University18 enrolled

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sebaceous Hyperplasia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 4-12 weeks

Change in sebaceous hyperplasia lesion count

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