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

Sponsor

Pulse Biosciences, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04539886

Collaborator

(none)

Enrollment

Locations

Arms

7.5

Actual Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Lesion Skin Abnormalities Sebaceous Hyperplasia	Device: CellFX System Device: Intralesional Electrodesiccation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 28, 2020

Actual Primary Completion Date :

Apr 23, 2021

Actual Study Completion Date :

May 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CellFX System 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.	Device: CellFX System 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)
Active Comparator: Intralesional Electrodesiccation 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.	Device: Intralesional Electrodesiccation Hyfrecator electrosurgical unit with a non-insulated needle-shaped electrode

Arm

Intervention/Treatment

Experimental: CellFX System

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.

Device: CellFX System

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)

Active Comparator: Intralesional Electrodesiccation

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.

Device: Intralesional Electrodesiccation

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

Outcome Measures

Primary Outcome Measures

Change in Lesion Appearance [60 days post last CellFX or Electrodessication treatment]
Measured by Global Aesthetic Improvement Scale (GAIS) Scale ranges from 1=Exceptional Improvement to 5=Worsened Appearance Compared with Original Condition
Adverse Skin Changes [60 days post last CellFX or Electrodessication treatment]
Presence or absence of a composite safety event

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigate MD, LLC	Scottsdale	Arizona	United States	85255
2	Zel Skin & Laser Specialists	Edina	Minnesota	United States	55424
3	Dermatology, Laser & Vein Specialists of the Carolinas, PLLC	Charlotte	North Carolina	United States	28207
4	Austin Institute for Clinical Research, Inc.	Houston	Texas	United States	77056
5	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas	United States	78660