Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-04

Study Completion Date

2018-05-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lesion Skin Seborrheic Keratosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Nano-Pulse Stimulation (NPS) Lesion

Three of four selected SK lesions receive Nano-Pulse Stimulation treatment.

Group Type ACTIVE_COMPARATOR

Nano-Pulse Stimulation (NPS)

Intervention Type DEVICE

The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.

Non-Treated Lesion

One of four SK lesions is randomized to not receiving Nano-Pulse Stimulation treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes