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Lasers for Sebaceous Hyperplasia

Phase 2

Waitlist Available

Led By Murad Alam, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age

Be older than 18 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing three different treatments for sebaceous hyperplasia to see which is the most effective.

Who is the study for?

This trial is for adults over 18 in good health living in the Chicago area, seeking cosmetic treatment for sebaceous hyperplasia. They must understand and sign a consent form. Excluded are those with poor wound healing, recent sun exposure affecting skin pigment, pregnant or nursing individuals, and anyone unable to communicate or cooperate due to language barriers or mental impairment.

What is being tested?

The study compares three treatments for sebaceous hyperplasia: Pulsed Dye Laser (PDL) plus Nd:YAG Laser; Erbium:YAG Laser; and Electrodessication & Curettage (ED&C). Each participant's lesions will be randomly assigned one of these treatments. Lesions get treated twice within 2-6 weeks and results are checked after 4-12 weeks.

What are the potential side effects?

Potential side effects from the laser treatments may include redness, swelling, bruising, pain at the treatment site, changes in skin coloration, blistering and scarring. ED&C might cause similar reactions along with potential bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can communicate and cooperate with the study team.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in sebaceous hyperplasia lesion count

Change in size of sebaceous hyperplasia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: ED&C treatmentActive Control1 Intervention

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.

Group II: Erbium:YAG LaserActive Control1 Intervention

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.

Group III: PDL plus Nd:YAGActive Control2 Interventions

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.

0 / 2Eligibility criteria met