Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

Skin Lesion Clinical Trial

Official title:

Evaluation of Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612570
• Other study ID #: NP-SH-006
• Status: Completed
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: November 28, 2018

Study information

• Verified date: April 2024
• Source: Pulse Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 28, 2018
• Est. primary completion date: September 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Sebaceous Hyperplasia
• Skin Abnormalities
• Skin Lesion

Intervention

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.

Locations

Country	Name	City	State
United States	Dermatology, Laser & Vein Specialists of the Carolinas, PLLC	Charlotte	North Carolina
United States	Skin Care Physicians	Chestnut Hill	Massachusetts
United States	Zel Skin & Laser Specialists	Edina	Minnesota
United States	Laser & Skin Surgery Medical Group, Inc.	Sacramento	California
United States	Premier Plastic Surgery	San Mateo	California

Sponsors (1)

Lead Sponsor	Collaborator
Pulse Biosciences, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):8 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Cleared SH Lesions	SH lesion clearance was assessed live by investigators for each treated SH lesion (n=222) at 60-days post-last treatment using a 4-point scale (i.e., 0, 1, 2, 3) where each number corresponded to Clear, Mostly Clear, Partially Clear, or Not Clear, respectively. Lower scores mean better outcome, i.e., 0=Clear while a 3=Not Clear.	60-days follow-up post-last treatment