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Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

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ClinicalTrials.gov Identifier: NCT03612570
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Pulse Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE July 27, 2018
First Posted Date  ICMJE August 2, 2018
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE July 10, 2018
Actual Primary Completion Date November 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
Lesion Clearance [ Time Frame: 60-day Follow-up ]
At least 50% of the NPS treated lesions will be rated as "CLEAR" or "MOSTLY CLEAR"
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia
Official Title  ICMJE Evaluation of Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia
Brief Summary This prospective, open label, muti-center study evaluates the use of Nano-Pulse Stimulation (NPS) in the treatment of Sebaceous Hyperplasia (SH) lesions less than 2.5mm in size.
Detailed Description The study is designed with each subject serving as his or her own control. A total of up to 75 subjects with 2-5 qualifying SH lesions will be enrolled and treated with either a 1.5-mm x 1.5-mm or 2.5-mm x 2.5-mm tip. One lesion will be randomized as a untreated control and no NPS energy will be delivered. All treated lesions will receive at least one NPS treatment and evaluated at 30 days for lesion clearance. Initial lesions scored as Not Clear or Partially Clear may undergo a second NPS treatment. All subjects will have their lesions evaluated at 60 days post-primary or secondary treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Lesion
  • Skin Abnormalities
  • Sebaceous Hyperplasia
Intervention  ICMJE Device: Nano-Pulse Stimulation Device
NPS utilizes a timed series of low energy, high voltage nanosecond (billionth of a second) pulses which are applied directly to targeted tissue using small microneedles. NPS energy induces cell signaling and the activation of cellular pathways by creating transient nanopores in cellular membranes and organelles and initiate regulated cell death.
Study Arms  ICMJE Experimental: NPS Treated SH Lesion
Nano-Pulse Stimulation Device using pre-defined energy protocol
Intervention: Device: Nano-Pulse Stimulation Device
Publications * Munavalli GS, Zelickson BD, Selim MM, Kilmer SL, Rohrer TE, Newman J, Jauregui L, Knape WA, Ebbers E, Uecker D, Nuccitelli R. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia. Dermatol Surg. 2020 Jun;46(6):803-809. doi: 10.1097/DSS.0000000000002154.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2019)
72
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2018)
75
Actual Study Completion Date  ICMJE December 20, 2018
Actual Primary Completion Date November 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females
  • Presents with at least 2 and up to 5 clinically visible SH lesions
  • Understands that 1 lesion will remain untreated to act as a reference
  • Lesions must measure no greater than 2.5 x 2.5 at the outside margin
  • Wishes to have at least 1 and perhaps 2 NPS treatments to each study lesion
  • Selection of the non-treated reference lesion will be randomly identified
  • Willing to return for 4 or 5 total study visits at specified intervals over 60 or 90 days
  • Agrees to photographic or other image capture methods of both the treated and untreated lesions.
  • Agrees to avoid any other treatment to the NPS treated and untreated SH lesions until the end of the NPS study
  • Has no evidence of active infection in the designated tissue prior to treatment and reports no infection within 90 days
  • Is not allergic to Lidocaine or Lidocaine-like products

Exclusion Criteria:

  • Presence of Implantable electronic devices that cannot be removed. e.g., pacemaker or automatic defibrillator
  • Taking medications prescribed for cardiac arrhythmia at any time within 6 months prior to exposure to the NPS device
  • SH lesions are located within the eye orbit or on the nose
  • Active infection or history of infection in designated test area within 90 days prior to study initiation
  • Use of oral steroid and/or retinoid use within the last 12 months
  • Prior treatment to the identified SH lesions targeted for the study which occurred within 6 months prior to study start
  • Is known to be immune-compromised and/or received immunosuppressant therapy within 6 months prior to study start
  • Taking blood thinning medications
  • Has Insulin dependent diabetes
  • Is known to be pregnant or lactating female
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03612570
Other Study ID Numbers  ICMJE NP-SH-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pulse Biosciences, Inc.
Study Sponsor  ICMJE Pulse Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Richard Nuccitelli, PhD Pulse Biosciences, Inc.
PRS Account Pulse Biosciences, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP