Skin Lesion Clinical Trial
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
Verified date | April 2024 |
Source | Pulse Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 18, 2021 |
Est. primary completion date | February 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Dermatology, Laser & Vein Specialists of the Carolinas, PLLC | Charlotte | North Carolina |
United States | Zel Skin & Laser Specialists | Edina | Minnesota |
United States | Austin Institute for Clinical Research, Inc. | Houston | Texas |
United States | Austin Institute for Clinical Research, Inc. | Pflugerville | Texas |
United States | Investigate MD, LLC | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Pulse Biosciences, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 |
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