Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

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

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.

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.

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