Sebaceous HyperplasiaPhase 2NCT04429607
Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial
A Phase 2 study testing Erbium:YAG Laser, Pulsed Dye Laser and Nd:YAG Laser in people with Sebaceous Hyperplasia, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sebaceous Hyperplasia
- What is being tested?
- Erbium:YAG Laser, Pulsed Dye Laser and Nd:YAG Laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
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.
- Conditions
- Sebaceous Hyperplasia
- Being tested
- Erbium:YAG Laser, Pulsed Dye Laser, Nd:YAG Laser, Electrodessication and curettage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erbium:YAG LaserDevice
Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.
Pulsed Dye LaserDevice
Also called PDL
PDL will be performed using settings of 6-10 J/s2 on lesions.
Nd:YAG LaserDevice
Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.
Electrodessication and curettageProcedure or surgery
Also called ED&C
Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.
| Study group | Role | What they receive |
|---|---|---|
| Erbium:YAG Laser | Active comparator | 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. Receives: Device: Erbium:YAG Laser |
| PDL plus Nd:YAG | Active comparator | 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. Receives: Device: Pulsed Dye Laser; Device: Nd:YAG Laser |
| ED&C treatment | Active comparator | 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. Receives: Procedure: Electrodessication and curettage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in size of sebaceous hyperplasia
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.
Measured: 4-12 weeks
Change in sebaceous hyperplasia lesion count
Change in sebaceous hyperplasia lesion count from baseline to 4-12 weeks after first treatment
Measured: 4-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start23 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sebaceous HyperplasiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429607
- Sponsor's protocol ID
- STU00211739
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2020
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04429607
- Acronym / sponsor ID
- STU00211739
- Conditions
- Sebaceous Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erbium:YAG Laser | Active comparator | Device: 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. |
| PDL plus Nd:YAG | Active comparator | Device: Pulsed Dye Laser, Device: Nd: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. |
| ED&C treatment | Active comparator | Procedure: Electrodessication and curettageSolitary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erbium:YAG LaserErbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions. | Device | Erbium:YAG Laser |
| Pulsed Dye LaserAlso: PDLPDL will be performed using settings of 6-10 J/s2 on lesions. | Device | PDL plus Nd:YAG |
| Nd:YAG LaserNd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions. | Device | PDL plus Nd:YAG |
| Electrodessication and curettageAlso: ED&CElectrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions. | Procedure or surgery | ED&C treatment |
Primary outcome
Change in size of sebaceous hyperplasia
Time frame: 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
Time frame: 4-12 weeks
Change in sebaceous hyperplasia lesion count from baseline to 4-12 weeks after first treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erbium:YAG Laser, Pulsed Dye Laser and Nd:YAG Laser in people with Sebaceous Hyperplasia, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in size of sebaceous hyperplasia (time frame: 4-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.