Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Erbium:YAG Laser, Pulsed Dye Laser, Nd:YAG Laser, Electrodessication and curettage.
- Who it may be relevant to
- Registry conditions: Sebaceous Hyperplasia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Device Erbium:YAG Laser
Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions. - Device Pulsed Dye Laser
PDL will be performed using settings of 6-10 J/s2 on lesions. - Device Nd:YAG Laser
Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions. - Procedure Electrodessication and curettage
Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.
Primary outcome measures
- Change in size of sebaceous hyperplasia [Time frame: 4-12 weeks]
- Change in sebaceous hyperplasia lesion count [Time frame: 4-12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Northwestern University Department of Dermatology — Chicago
Identifiers
NCT: NCT04429607 · STU00211739