Clinical trial NCT04539886: Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Lesion
Skin Abnormalities
Sebaceous Hyperplasia
Keywords: CellFX
Nano-Pulse Stimulation
NPS
Clearance
Lead sponsor: Pulse Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS)
timeFrame: 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.
measure: Percentage of Lesions With Hyperpigmentation, Hypopigmentation and Scarring as Assessed by Blinded Investigator During Live Assessments
timeFrame: 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.
measure: Percentage of Lesions With Skin Textual Changes as Assessed by Blinded Investigator During Live Skin Assessment
timeFrame: 30 days post last CellFX or Electrodessication treatment, up to a maximum of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigate MD, LLC
state: Arizona
city: Edina
country: United States
facility: Zel Skin & Laser Specialists
state: Minnesota
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
state: North Carolina
city: Houston
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
Study officials:
affiliation: Pulse Biosciences, Inc.
name: Richard Nuccitelli, PhD
role: STUDY_CHAIR
References: