Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

Not Applicable

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
NPS Treated SH Lesion	Nano-Pulse Stimulation Device	Nano-Pulse Stimulation Device using pre-defined energy protocol

Primary Outcome Measures

Name	Time	Method
Total Number of Cleared SH Lesions	60-days follow-up post-last treatment	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.

Secondary Outcome Measures

Name	Time	Method

Locations (5): Skin Care Physicians
🇺🇸
Chestnut Hill, Massachusetts, United States
Zel Skin & Laser Specialists
🇺🇸
Edina, Minnesota, United States
Premier Plastic Surgery
🇺🇸
San Mateo, California, United States
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
🇺🇸
Charlotte, North Carolina, United States
Laser & Skin Surgery Medical Group, Inc.
🇺🇸
Sacramento, California, United States