Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Northwestern University
- Study ID
- NCT04429607
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Sebaceous Hyperplasia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Erbium:YAG Laser — DEVICEErbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.
- Pulsed Dye Laser — DEVICEPDL will be performed using settings of 6-10 J/s2 on lesions.
- Nd:YAG Laser — DEVICENd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.
- Electrodessication and curettage — PROCEDUREElectrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.
Study Details
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.
Key Dates
- Start date
- Jul 31, 2025
- Status verified
- Apr 2025
- Primary completion
- Jun 30, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 18 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Erbium:YAG LaserSolitary 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.
- Active Comparator: PDL plus Nd:YAGSolitary 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.
- Active Comparator: ED&C treatmentSolitary 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.
Primary Outcome Measure
Change in size of sebaceous hyperplasia [ Time Frame: 4-12 weeks ]
Central Contacts
- DermCTU3126958106
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | Murad Alam, MD (PRINCIPAL_INVESTIGATOR) |