Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Not Applicable

Completed

• Conditions: Lesion Skin; Seborrheic Keratosis
• Interventions: Device: Nano-Pulse Stimulation (NPS)

• Registration Number: NCT03846531
• Lead Sponsor: Pulse Biosciences, Inc.

Brief Summary

The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.

Detailed Description

Evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.

The specific objectives of this study are to:

* Document the non-treated appearance of off-face SKs.

* Evaluate the clearance of SKs in off-face locations post-treatment versus pre-treated appearance of the same lesion.

* Evaluate the clearance of the treated SKs at various points in time over several weeks following the initial procedure, compared to the pre-treated SKs.

Study Timeline

• Study Start: 2017-05-04
• Primary Completion: 2017-11-13
• Study Completion: 2018-05-22
• Study First Submitted: 2019-02-17
• Study First Submitted QC: 2019-02-17
• Study First Posted: 2019-02-19
• Status Verified: 2023-07
• Results First Submitted: 2023-07-01
• Results First Submitted QC: 2023-07-31
• Last Update Submitted: 2023-07-31
• Results First Posted: 2023-08-22
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Willing to sign the informed consent
• Has a clinical diagnosis of stable, clinically typical seborrheic keratosis
• Medically determined candidate for at least 4 off-face SK lesions
• Must have at least four treatable SK lesions and be willing to have NPS treatment on any three of the four treatable SK lesions. Treatable SK lesions must: be at least 1 mm in height, and no greater than 3 mm in height and not have a dimension perpendicular to the longest dimension of greater than 7.5mm or longer in any dimension than 20mm
• Willing to have three of the designated SK lesions treated in a single treatment session
• Willing to return to the PI's office for five additional study visits at specified intervals over 106-days
• Agrees to high resolution photos of both the treated SK lesions and the untreated SK lesion
• No subject identity will be possible via the "lesion-only" photograph
• No evidence of active infection in the designated tissue prior to treatment
• Is not allergic to Lidocaine or Lidocaine-like products
• Not pregnant or lactating

Exclusion Criteria

• Has an implantable electronic device (e.g., automatic defibrillator)
• Active infection or history of infection within 90 previous days in designated test area
• Not willing or able to sign the Informed Consent
• Non-English speaking or reading
• Is known to be immune-compromised
• Known to be a keloid producer
• On blood thinning medications
• Diseases, conditions, or situations wherein the PI judges that the patient is not appropriate for participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Nano-Pulse Stimulation (NPS) Lesion	Nano-Pulse Stimulation (NPS)	Three of four selected SK lesions receive Nano-Pulse Stimulation treatment.

Primary Outcome Measures

Name	Time	Method
Clearance of SK Lesions	106-day post-treatment	Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site.

Trial Locations

Locations (4)

Zel Skin & Laser Specialists; 🇺🇸 Edina, Minnesota, United States

Premier Plastic Surgery; 🇺🇸 San Mateo, California, United States

Laser & Dermatologic Surgery Center; 🇺🇸 Chesterfield, Missouri, United States

Skin Care Physicians; 🇺🇸 Chestnut Hill, Massachusetts, United States