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Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial

Primary Purpose

Sebaceous Hyperplasia

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erbium:YAG Laser
Pulsed Dye Laser
Nd:YAG Laser
Electrodessication and curettage
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sebaceous Hyperplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern University Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Erbium:YAG Laser

PDL plus Nd:YAG

ED&C treatment

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
Change in sebaceous hyperplasia lesion count
Change in sebaceous hyperplasia lesion count from baseline to 4-12 weeks after first treatment

Secondary Outcome Measures

Full Information

First Posted
June 10, 2020
Last Updated
February 17, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04429607
Brief Title
Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial
Official Title
Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sebaceous Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erbium:YAG Laser
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PDL plus Nd:YAG
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ED&C treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Erbium:YAG Laser
Intervention Description
Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.
Intervention Type
Device
Intervention Name(s)
Pulsed Dye Laser
Other Intervention Name(s)
PDL
Intervention Description
PDL will be performed using settings of 6-10 J/s2 on lesions.
Intervention Type
Device
Intervention Name(s)
Nd:YAG Laser
Intervention Description
Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.
Intervention Type
Procedure
Intervention Name(s)
Electrodessication and curettage
Other Intervention Name(s)
ED&C
Intervention Description
Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.
Primary Outcome Measure Information:
Title
Change in size of sebaceous hyperplasia
Description
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.
Time Frame
4-12 weeks
Title
Change in sebaceous hyperplasia lesion count
Description
Change in sebaceous hyperplasia lesion count from baseline to 4-12 weeks after first treatment
Time Frame
4-12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≥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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandra Onate, M.S.
Phone
312-695-6647
Email
onate@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra Onate, M.S.
Phone
312-695-6647
Email
onate@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial

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