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

Sebaceous Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04429607
• Other study ID #: STU00211739
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: DermCTU
• Phone: 3126958106
• Email: NUderm-research[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Sebaceous Hyperplasia

Intervention

Device:
• Erbium:YAG Laser
Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.
• Pulsed Dye Laser
PDL will be performed using settings of 6-10 J/s2 on lesions.
• Nd:YAG Laser
Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.

Procedure:
• Electrodessication and curettage
Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4-12 weeks
Primary	Change in sebaceous hyperplasia lesion count	Change in sebaceous hyperplasia lesion count from baseline to 4-12 weeks after first treatment	4-12 weeks