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Trial record 10 of 14 for:    "Keratosis seborrheic"

Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

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ClinicalTrials.gov Identifier: NCT03846531
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lesion Skin Seborrheic Keratosis Device: Nano-Pulse Stimulation (NPS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Each subject served as their own control. Each subject had 4 lesions with 3 of the lesions serving in the Active Comparative Arm (Lesions treated with Nano-Pulse Stimulation) and 1 lesion serving as control not treated with Nano-Pulse Stimulation and assigned to No Intervention Arm.
Masking: Single (Outcomes Assessor)
Masking Description: A Reference Key was developed for 3 independent reviewers to use during their review of the full set (196 image pairs) of study photographs. The reference key included 2 representative photographs for each of the 4 possible scores used in the SK study (clear, mostly clear, partially clear, and not clear). The three independent reviewers were not principal investigators at enrolling centers.
Primary Purpose: Treatment
Official Title: Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis
Actual Study Start Date : May 4, 2017
Actual Primary Completion Date : November 13, 2017
Actual Study Completion Date : May 22, 2018

Arm Intervention/treatment
Active Comparator: Nano-Pulse Stimulation (NPS) Lesion
Three of four selected SK lesions receive Nano-Pulse Stimulation treatment.
Device: Nano-Pulse Stimulation (NPS)
The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.

No Intervention: Non-Treated Lesion
One of four SK lesions is randomized to not receiving Nano-Pulse Stimulation treatment.



Primary Outcome Measures :
  1. SK Lesion Clearance [ Time Frame: 106-day post-treatment ]
    Degree of clearance of SK lesions treated with NPS as rated by an independent reviewer's assessment of photographs of the lesions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846531


Locations
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United States, California
Premier Plastic Surgery
San Mateo, California, United States, 94401
United States, Massachusetts
Skin Care Physicians
Chestnut Hill, Massachusetts, United States, 02467
United States, Minnesota
Zel Skin & Laser Specialists
Edina, Minnesota, United States, 55424
United States, Missouri
Laser & Dermatologic Surgery Center
Chesterfield, Missouri, United States, 63017
Sponsors and Collaborators
Pulse Biosciences, Inc.
Investigators
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Study Chair: Richard A Nuccitelli, PhD Pulse Biosciences, Inc.

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Responsible Party: Pulse Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03846531     History of Changes
Other Study ID Numbers: NP-SK-002
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Pulse Biosciences, Inc.:
Nano-Pulse Stimulation
Seborrheic Keratosis

Additional relevant MeSH terms:
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Keratosis
Keratosis, Actinic
Keratosis, Seborrheic
Skin Diseases
Precancerous Conditions
Neoplasms