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
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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NOT_YET_RECRUITING
PHASE2
18 participants
INTERVENTIONAL
2025-07-31
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
Erbium:YAG Laser
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.
Pulsed Dye Laser
PDL will be performed using settings of 6-10 J/s2 on lesions.
Nd:YAG Laser
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.
Electrodessication and curettage
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.
Pulsed Dye Laser
PDL will be performed using settings of 6-10 J/s2 on lesions.
Nd:YAG Laser
Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.
Electrodessication and curettage
Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Murad Alam
Professor of Dermatology
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
Countries
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Central Contacts
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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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