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Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions

Primary Purpose

Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CellFX System

Intralesional Electrodesiccation

About this trial

This is an interventional treatment trial for Skin Lesion focused on measuring CellFX, Nano-Pulse Stimulation, NPS, Clearance

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is at least 21 and no older than 80 years of age.
Subject gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Subject must comply with study procedures including follow-up visits.
Subject is willing to have SH lesions treated in a single treatment session and understands that their lesion(s) may undergo a second treatment session at a subsequent visit.
Subject must have a minimum of four SH lesions and up to 10 SH lesions to be treated and the subject must have at least two SH lesions located on each side of the face.
For study purposes, the SH lesions must be no greater than 2 mm in height and must not exceed 5 mm x 5 mm at their largest dimension. The subject's lesions cannot be located within the eye orbit, nose, or scalp.
Subject consents to have photographs taken of the SH lesion(s).
Subject agrees to refrain from using all other lesion removal products or treatments (e.g. retinols, retinoids, and exfoliating products) to the treated SH lesions or any new SH lesions during the study period.
Subject agrees to refrain from prolonged sun exposure during the study period.

Exclusion Criteria:

Subject has an implantable electronic medical device.(i.e., pacemaker, implantable cardioverter defibrillator)
Subject has an active infection or history of infection in designated test area within 90 days prior to first treatment.
Subject is not willing or able to sign the Informed Consent.
Subject is known to be immune compromised.
Subject is prone to developing hypertrophic scars or to be a keloid producer.
Subject has allergies to Lidocaine or Lidocaine-like products.
Subject is employed by the sponsor, clinic site, or entity associated with the conduct of the study.
Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study.
Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study.
Subject was previously treated with CellFX for SH lesions.

Sites / Locations

Investigate MD, LLC
Zel Skin & Laser Specialists
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
Austin Institute for Clinical Research, Inc.
Austin Institute for Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CellFX System

Intralesional Electrodesiccation

Arm Description

The CellFX System consists of a electrical pulse console combined with a handpiece coupled with a sterile single patient-use treatment tip (1.5 x 1.5mm, 2.5 x 2.5mm, and 5.0 x 5.0mm). Based on the size of the SH lesion and treatment tip used, a predetermined treatment energy setting is selected to deliver a sequence of electrical pulses to the SH lesion area directly beneath the treatment tip.

Intralesional Electrodesiccation involves using a Hyfrecator electrosurgical unit and a non-insulated epilation needle electrode to apply a high-frequency electric current within the lesion.

Outcomes

Primary Outcome Measures

Change in Lesion Appearance

Measured by Global Aesthetic Improvement Scale (GAIS) Scale ranges from 1=Exceptional Improvement to 5=Worsened Appearance Compared with Original Condition

Adverse Skin Changes

Presence or absence of a composite safety event

Secondary Outcome Measures

Full Information

NCT ID

NCT04539886

First Posted

August 31, 2020

Last Updated

May 29, 2021

Sponsor

Pulse Biosciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04539886

Brief Title

Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions

Official Title

A Multicenter, Prospective, Randomized, Comparison IDE Study Between the Pulse Biosciences CellFX System and Electrodessication (Hyfrecator Electrosurgical) for the Treatment of Sebaceous Hyperplasia (SH) Lesions

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

September 28, 2020 (Actual)

Primary Completion Date

April 23, 2021 (Actual)

Study Completion Date

May 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pulse Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This study is designed as a multi-center, single-blinded, prospective, randomized, study to compare the safety and effectiveness of the CellFX System to the comparator group, Electrodessication for the treatment of SH lesions in healthy adult subjects.

Detailed Description

This SH comparative study will evaluate safety and efficacy in a split face design using the CellFX System and pre-defined energy profile for all primary and secondary treatments based on Fitzpatrick Skin Types and tip size. The comparator group will be treated with the same standardized intralesional electrodesiccation procedure conducted by all participating clinical sites. Subjects with 4-10 qualifying SH lesions on the face except the scalp, nose and within the orbital region will be enrolled. Each subject will be evaluated by the blinded site investigator at 7-days, 30-days, and 60-days post-initial CellFX and Electrodessication treatments. At the 30-day follow-up visit, lesions will be evaluate using Global Aesthetic Improvement Scale (GAIS), for eligibility to receive an additional treatment. In case of a second treatment, the subject will be evaluated by the blinded site investigator at 30-days and 60-days post-retreatment. Photography of the study lesions will be captured along with the blinded site investigator assessments at all visits.

6. Conditions and Keywords

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

Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia

Keywords

CellFX, Nano-Pulse Stimulation, NPS, Clearance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Subjects will be randomized to receiving the two treatments in a split-face design with CellFX being used on only one side of the face and Electrodessication on the other side. The randomization assignment will include the type of treatment and which side of the face.

Masking

Outcomes Assessor

Masking Description

The Principal Investigator will select a sub investigator to be the blinded investigator to classify healing characteristics and aesthetic appearance of each subject's selected lesions at baseline and treated lesions post treatment and at 7-days, 30-days, and 60-days following the last CellFX treatment or Electrodessication. This sub investigator will be blinded to the treatment assignment. The subject may not be blinded to the treatment assignment.

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CellFX System

Arm Type

Experimental

Arm Description

Arm Title

Intralesional Electrodesiccation

Arm Type

Active Comparator

Arm Description

Intralesional Electrodesiccation involves using a Hyfrecator electrosurgical unit and a non-insulated epilation needle electrode to apply a high-frequency electric current within the lesion.

Intervention Type

Device

Intervention Name(s)

CellFX System

Intervention Description

CellFX System consists of a console combined with a handpiece and coupled with a sterile single patient-use treatment tip (1.5 x 1.5mm, 2.5 x 2.5mm, and 5.0 x 5.0mm)

Intervention Type

Device

Intervention Name(s)

Intralesional Electrodesiccation

Intervention Description

Hyfrecator electrosurgical unit with a non-insulated needle-shaped electrode

Primary Outcome Measure Information:

Title

Change in Lesion Appearance

Description

Measured by Global Aesthetic Improvement Scale (GAIS) Scale ranges from 1=Exceptional Improvement to 5=Worsened Appearance Compared with Original Condition

Time Frame

60 days post last CellFX or Electrodessication treatment

Title

Adverse Skin Changes

Description

Presence or absence of a composite safety event

Time Frame

60 days post last CellFX or Electrodessication treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is at least 21 and no older than 80 years of age. Subject gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. Subject must comply with study procedures including follow-up visits. Subject is willing to have SH lesions treated in a single treatment session and understands that their lesion(s) may undergo a second treatment session at a subsequent visit. Subject must have a minimum of four SH lesions and up to 10 SH lesions to be treated and the subject must have at least two SH lesions located on each side of the face. For study purposes, the SH lesions must be no greater than 2 mm in height and must not exceed 5 mm x 5 mm at their largest dimension. The subject's lesions cannot be located within the eye orbit, nose, or scalp. Subject consents to have photographs taken of the SH lesion(s). Subject agrees to refrain from using all other lesion removal products or treatments (e.g. retinols, retinoids, and exfoliating products) to the treated SH lesions or any new SH lesions during the study period. Subject agrees to refrain from prolonged sun exposure during the study period. Exclusion Criteria: Subject has an implantable electronic medical device.(i.e., pacemaker, implantable cardioverter defibrillator) Subject has an active infection or history of infection in designated test area within 90 days prior to first treatment. Subject is not willing or able to sign the Informed Consent. Subject is known to be immune compromised. Subject is prone to developing hypertrophic scars or to be a keloid producer. Subject has allergies to Lidocaine or Lidocaine-like products. Subject is employed by the sponsor, clinic site, or entity associated with the conduct of the study. Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study. Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study. Subject was previously treated with CellFX for SH lesions.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Nuccitelli, PhD

Organizational Affiliation

Pulse Biosciences, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Investigate MD, LLC

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85255

Country

United States

Facility Name

Zel Skin & Laser Specialists

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55424

Country

United States

Facility Name

Dermatology, Laser & Vein Specialists of the Carolinas, PLLC

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Austin Institute for Clinical Research, Inc.

City

Houston

State/Province

Texas

ZIP/Postal Code

77056

Country

United States

Facility Name

Austin Institute for Clinical Research, Inc.

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions

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