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
|Condition or disease||Intervention/treatment||Phase|
|Lesion Skin Seborrheic Keratosis||Device: Nano-Pulse Stimulation (NPS)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|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.|
|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|
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.
- 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.
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
|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|
|Study Chair:||Richard A Nuccitelli, PhD||Pulse Biosciences, Inc.|