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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03612570
Other study ID # NP-SH-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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