Clinical trial NCT03612570: Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia
Official title: Evaluation of Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Lesion
Skin Abnormalities
Sebaceous Hyperplasia
Keywords: Nano-Pulse Stimulation
NPS
Lead sponsor: Pulse Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Number of Cleared SH Lesions
timeFrame: 60-days follow-up post-last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser & Skin Surgery Medical Group, Inc.
state: California
city: San Mateo
country: United States
facility: Premier Plastic Surgery
state: California
city: Chestnut Hill
country: United States
facility: Skin Care Physicians
state: Massachusetts
city: Edina
country: United States
facility: Zel Skin & Laser Specialists
state: Minnesota
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
state: North Carolina
Study officials:
affiliation: Pulse Biosciences, Inc.
name: Richard Nuccitelli, PhD
role: STUDY_CHAIR
References:
citation: 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.