Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia Optimization Study (NCT04253418) | Clinical Trial Compass
TerminatedNot Applicable
Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia Optimization Study
Stopped: Study enrollment was halted due to a business decision by the Sponsor to focus resources on other clinical areas outside of dermatology.
United States125 participantsStarted 2018-12-20
Plain-language 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.
Who can participate
Age range21 Years – 75 Years
SexALL
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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 en…