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

Completed · Not applicable

Conditions studied: Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia

In brief

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.

Key facts

Study ID: NCT04539886
Run by: Pulse Biosciences, Inc.
People needed: 60
Starts: 2020-09-28
Expected to finish: 2021-11-18
Last updated by the study team: 2024-04-25

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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