Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

Completed · Not applicable

Conditions studied: Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia

In brief

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.

Key facts

Study ID

NCT03612570

Run by

Pulse Biosciences, Inc.

People needed

72

Starts

2018-06-28

Expected to finish

2018-11-28

Last updated by the study team

2024-04-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.