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

NCT ID: NCT04539886

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2021-11-18

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.

Conditions

Skin Lesion; Skin Abnormalities; Sebaceous Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

CellFX System

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

Intralesional Electrodesiccation

Intervention Type: DEVICE

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

Interventions

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)

Intervention Type: DEVICE

Intralesional Electrodesiccation

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulse Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Nuccitelli, PhD

Role: STUDY_CHAIR

Pulse Biosciences, Inc.

Locations

Investigate MD, LLC

Scottsdale, Arizona, United States

Zel Skin & Laser Specialists

Edina, Minnesota, United States

Dermatology, Laser & Vein Specialists of the Carolinas, PLLC

Charlotte, North Carolina, United States

Austin Institute for Clinical Research, Inc.

Houston, Texas, United States

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NP-SC-012

Identifier Type: -

Identifier Source: org_study_id