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

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Abnormalities; Skin Lesion; Sebaceous Hyperplasia
• Intervention / Treatment: Device: CellFX System; Device: Intralesional Electrodesiccation

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Investigate MD, LLC
  • Minnesota
    • Edina, Minnesota, United States, 55424
      • Zel Skin & Laser Specialists
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
  • Texas
    • Houston, Texas, United States, 77056
      • Austin Institute for Clinical Research, Inc.
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS)	Percentage of SH Lesions with Improvement as Assessed by Blinded Investigator During Live Assessments based on Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale ranges from 1=Very Much Improved or Excellent Corrective Result to 5=Worsened Appearance Compared with Original Condition. The primary effectiveness endpoint of improvement at 60-days post-last treatment as assessed "live" by the blinded site investigator using the 5-point GAIS	60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.
Percentage of Lesions With Hyperpigmentation, Hypopigmentation and Scarring as Assessed by Blinded Investigator During Live Assessments	The first co-primary safety endpoint includes the percentage of lesions showing hyperpigmentation and scarring as assessed by the blinded Investigator at 60 days after the last treatment with CellFX or Electrodessication	60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.
Percentage of Lesions With Skin Textual Changes as Assessed by Blinded Investigator During Live Skin Assessment	The second co-primary safety endpoint of skin textural changes including; flaking, erythema, crusting, scabbing, or other skin irregularities was assessed by the blinded site investigator at 30 days post last CellFX or Electrodessication treatment.	30 days post last CellFX or Electrodessication treatment, up to a maximum of 2 months

Collaborators and Investigators

• Sponsor: Pulse Biosciences, Inc.
• Investigators: Study Chair: Richard Nuccitelli, PhD, Pulse Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): February 2, 2021
• Study Completion (Actual): November 18, 2021

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Clearance; NPS; CellFX; Nano-Pulse Stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Congenital Abnormalities; Hyperplasia; Skin Abnormalities
• Other Study ID Numbers: NP-SC-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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