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

NCT04539886 | Completed Results FDA Device

• 1 other identifier: NP-SC-012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Skin Lesion; Skin Abnormalities; Sebaceous Hyperplasia

Keywords

CellFX; Nano-Pulse Stimulation; NPS; Clearance

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

CellFX System

EXPERIMENTAL

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

Intralesional Electrodesiccation

ACTIVE COMPARATOR

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

Interventions

CellFX System DEVICE

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)

CellFX System

Intralesional Electrodesiccation DEVICE

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

Intralesional Electrodesiccation

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead

Study Sites (5)

Investigate MD, LLC

Scottsdale, Arizona, 85255, United States

Location

Zel Skin & Laser Specialists

Edina, Minnesota, 55424, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas, PLLC

Charlotte, North Carolina, 28207, United States

Location

Austin Institute for Clinical Research, Inc.

Houston, Texas, 77056, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Conditions

Skin Abnormalities

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: William A. Knape, VP Clinical, Regulatory and Quality Affairs
• Organization: Pulse Biosciences, Inc.

bknape@pulsebiosciences.com

510-906-4649

Study Officials

• Richard Nuccitelli, PhD

  Pulse Biosciences, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: September 28, 2020
• Primary Completion: February 2, 2021
• Study Completion: November 18, 2021
• Last Updated: April 25, 2024
• Results First Posted: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)