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 — DEVICE
    Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.
  • Pulsed Dye Laser — DEVICE
    PDL will be performed using settings of 6-10 J/s2 on lesions.
  • Nd:YAG Laser — DEVICE
    Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.
  • Electrodessication and curettage — PROCEDURE
    Electrodessication 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 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.
  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Change in size of sebaceous hyperplasia [ Time Frame: 4-12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University Department of DermatologyChicagoIllinois60611
Murad Alam, MD (PRINCIPAL_INVESTIGATOR)

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