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

NCT ID: NCT04429607

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-12-31

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.

Detailed Description

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Conditions

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Sebaceous Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Erbium:YAG Laser

Intervention Type DEVICE

Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.

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.

Group Type ACTIVE_COMPARATOR

Pulsed Dye Laser

Intervention Type DEVICE

PDL will be performed using settings of 6-10 J/s2 on lesions.

Nd:YAG Laser

Intervention Type DEVICE

Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.

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.

Group Type ACTIVE_COMPARATOR

Electrodessication and curettage

Intervention Type PROCEDURE

Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.

Interventions

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Erbium:YAG Laser

Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.

Intervention Type DEVICE

Pulsed Dye Laser

PDL will be performed using settings of 6-10 J/s2 on lesions.

Intervention Type DEVICE

Nd:YAG Laser

Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.

Intervention Type DEVICE

Electrodessication and curettage

Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.

Intervention Type PROCEDURE

Other Intervention Names

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PDL ED&C

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Central Contacts

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DermCTU

Role: CONTACT

3126958106

Facility Contacts

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Role: primary

Other Identifiers

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STU00211739

Identifier Type: -

Identifier Source: org_study_id

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