Sebaceous Hyperplasia
Conditions
Brief summary
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
DEVICEErbium:YAG Laser
Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.
DEVICEPulsed Dye Laser
PDL will be performed using settings of 6-10 J/s2 on lesions.
DEVICENd:YAG Laser
Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.
PROCEDUREElectrodessication and curettage
Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in size of sebaceous hyperplasia | 4-12 weeks | 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. |
| Change in sebaceous hyperplasia lesion count | 4-12 weeks | Change in sebaceous hyperplasia lesion count from baseline to 4-12 weeks after first treatment |
Countries
United States
Contacts
Primary ContactDermCTU
Outcome results
None listed