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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04253418
Other study ID # NP-SH-009
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 20, 2018
Est. completion date March 26, 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 Sebaceous Hyperplasia (SH) lesions from facial areas of healthy adult subjects.


Description:

- Evaluate lesion clearance of treated facial Sebaceous Hyperplasia lesions using multiple sized treatment tips with microneedles. - Evaluate lesion clearance of the treated Sebaceous Hyperplasia lesions using multiple energy settings levels at various time points. - Evaluate skin effects and adverse event rate.


Recruitment information / eligibility

Status Terminated
Enrollment 125
Est. completion date March 26, 2021
Est. primary completion date May 14, 2020
Accepts healthy volunteers No
Gender All
Age group 21 Years to 75 Years
Eligibility Inclusion Criteria: - Male or Female between 18 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 are willing to return for all the required follow-up visits. - Understands that SHs are to be treated in a single treatment session is aware that they may receive a second treatment at their third study visit - Must be able to visit clinic site at 7-, 30-, 60-days post-primary treatment of SH lesion and at 30- and 60-days post-retreatment. - Clinically diagnosis of typical sebaceous hyperplasia. - Minimum of four SH lesions. - Undergo all study procedures including consent for photographs of the treated SH sites. - Agrees to refrain from using all other SH lesion removal products or treatments (topical medication including over-the-counter medications) during the study period. Exclusion Criteria: - Implantable electronic devices (i.e., pacemaker, implantable cardioverter 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 a 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. - 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. - Known 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 SH 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 United Skin Physicians Chestnut Hill Massachusetts
United States Capital Laser & Skin Care Chevy Chase Maryland
United States Laser and Skin Surgery Center of Northern California Sacramento California
United States AVA MD Santa Monica California
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 SH Lesion Clearance Rate Clearance of SH lesions treated with NPS as rated by investigators. 60-days post-last NPS treatment
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