Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04249115
Other study ID # NP-SK-008
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 5, 2019
Est. completion date April 22, 2021

Study information

Verified date October 2023
Source Pulse Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Seborrheic Keratosis (SKs) from off-facial areas of healthy adults.


Description:

- Evaluate lesion clearance rate of SKs in off-face locations post-treatment versus baseline using multiple sized treatment tips with microneedles. - Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure, compared baseline. - Evaluate skin effects and adverse event rate.


Recruitment information / eligibility

Status Terminated
Enrollment 175
Est. completion date April 22, 2021
Est. primary completion date August 13, 2020
Accepts healthy volunteers No
Gender All
Age group 21 Years to 75 Years
Eligibility Inclusion Criteria: - Male or Female between 21 and 75 years of age - Voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained - Understanding of the clinical investigation, agree to cooperate with the investigational procedures and willing to return for all the required follow-up visits - Understands that SKs are to be treated in a single treatment session and is aware that they may receive a second treatment - Must be able to visit clinic site at 7-, 30-, 60-, and 90-days post-primary treatment of SK lesion and at retreatment - Clinical diagnosis of stable, clinically typical Seborrheic Keratosis - Minimum of two SK lesions - SKs must be no greater than 2mm in height and not exceed 10mm x 10mm at their largest point - Undergo all study procedures including consent for global photographs of the SK study sites - Agrees to refrain from using all other SK lesion removal products or treatments (topical medication including over-the-counter medications) during the study period Exclusion Criteria: - Implantable electronic devices (i.e., automatic defibrillator) - Active infection or history of infection in designated test area within 90 days prior to first treatment - Not willing or able to sign the Informed Consent - Known to be immune-compromised - Known to be keloid producer - Taking blood thinning medications - Insulin dependent, Type I diabetics - Allergies to Lidocaine or Lidocaine-like products - Employed by the sponsor, clinic site, or entity associated with the conduct of the study - Family member of someone 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 - Prior inability to complete required study visits during treatment period. - Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study

Study Design


Intervention

Device:
Nano-Pulse Stimulation (NPS)
Electrical pulses (nanosecond duration) applied directly to target SK lesions using sterile single-patient use treatment tips with microneedles.

Locations

Country Name City State
United States Dermatology, Laser & Vein Specialists of the Carolinas Charlotte North Carolina
United States Skin Care Physicians Chestnut Hill Massachusetts
United States Chicago Cosmetic Surgery and Dermatology Chicago Illinois
United States SKIN Associates of South Florida Coral Gables Florida
United States Zel Skin & Laser Specialists Edina Minnesota
United States Mountain Dermatology Specialists Edwards Colorado
United States Clear Dermatology & Aesthetics Center / InvestigateMD Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Pulse Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clearance Rate of SK Lesions Degree of Clearance of SK lesion treated with NPS as rated by investigators. 90 days post-last treatment
See also
  Status Clinical Trial Phase
Completed NCT04539886 - Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions N/A
Not yet recruiting NCT05418959 - Genetic Risk Stratification of Pediatric Skin Lesions Phase 1
Recruiting NCT05068310 - Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors
Completed NCT05619471 - VIO Imaging for Skin Tissue Assessment (VISTA) N/A
Recruiting NCT03716193 - Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry N/A
Completed NCT03914274 - Adequate Sock to Avoid Hiking Injuries N/A
Completed NCT04821193 - Comparison of the Effects of 5%NaHCO3, 2%CHG and 70%Alcohol in the Prevention of Infections Related to Catheter N/A
Completed NCT05729334 - Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions N/A
Completed NCT02598609 - SEPREVEN: a Stepped-wedge Randomised Controlled Trial N/A
Completed NCT05994781 - A Prospective Researcher-led Clinical Study of Neopep-S-based EasyDew MD Regen Cream N/A
Completed NCT06025058 - Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection N/A
Completed NCT00470912 - Sunscreen RV 2457C in Photoinduced CLE Phase 3
Completed NCT05410964 - Non-Linear Imaging of Skin In Vivo
Withdrawn NCT03357419 - The Effect of Prophylactic Antibiotics on Surgical Site Infection Lower Limb Skin Excisions N/A
Completed NCT02740257 - Smartphone Application to Detect Skin Lesions
Completed NCT03612570 - Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia N/A
Recruiting NCT03796871 - Medical Device Based on Polarized Light for Cutaneous Lesions Visualization N/A
Completed NCT05238870 - Prevention of Skin Damage in the Patient in Prone Position: Development of Education Interventions Based on a Training Needs Assessment Study.
Completed NCT05940090 - Correlation of Dermatologist Made Biopsy Decision With AI Assisted Total Body Photography Detection of Outlier Lesions
Enrolling by invitation NCT04566302 - Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy N/A