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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
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