Skin Lesion Clinical Trial
Official title:
Evaluation of Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia
Verified date | April 2024 |
Source | Pulse Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | November 28, 2018 |
Est. primary completion date | September 5, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dermatology, Laser & Vein Specialists of the Carolinas, PLLC | Charlotte | North Carolina |
United States | Skin Care Physicians | Chestnut Hill | Massachusetts |
United States | Zel Skin & Laser Specialists | Edina | Minnesota |
United States | Laser & Skin Surgery Medical Group, Inc. | Sacramento | California |
United States | Premier Plastic Surgery | San Mateo | California |
Lead Sponsor | Collaborator |
---|---|
Pulse Biosciences, Inc. |
United States,
Munavalli GS, Zelickson BD, Selim MM, Kilmer SL, Rohrer TE, Newman J, Jauregui L, Knape WA, Ebbers E, Uecker D, Nuccitelli R. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia. Dermatol Surg. 2020 Jun;46(6):8 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Number of Cleared SH Lesions | SH lesion clearance was assessed live by investigators for each treated SH lesion (n=222) at 60-days post-last treatment using a 4-point scale (i.e., 0, 1, 2, 3) where each number corresponded to Clear, Mostly Clear, Partially Clear, or Not Clear, respectively. Lower scores mean better outcome, i.e., 0=Clear while a 3=Not Clear. | 60-days follow-up post-last treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04539886 -
Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions
|
N/A | |
Not yet recruiting |
NCT05418959 -
Genetic Risk Stratification of Pediatric Skin Lesions
|
Phase 1 | |
Recruiting |
NCT05068310 -
Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors
|
||
Completed |
NCT05619471 -
VIO Imaging for Skin Tissue Assessment (VISTA)
|
N/A | |
Recruiting |
NCT03716193 -
Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry
|
N/A | |
Completed |
NCT03914274 -
Adequate Sock to Avoid Hiking Injuries
|
N/A | |
Completed |
NCT04821193 -
Comparison of the Effects of 5%NaHCO3, 2%CHG and 70%Alcohol in the Prevention of Infections Related to Catheter
|
N/A | |
Completed |
NCT05729334 -
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
|
N/A | |
Completed |
NCT02598609 -
SEPREVEN: a Stepped-wedge Randomised Controlled Trial
|
N/A | |
Completed |
NCT06025058 -
Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection
|
N/A | |
Completed |
NCT05994781 -
A Prospective Researcher-led Clinical Study of Neopep-S-based EasyDew MD Regen Cream
|
N/A | |
Completed |
NCT00470912 -
Sunscreen RV 2457C in Photoinduced CLE
|
Phase 3 | |
Completed |
NCT05410964 -
Non-Linear Imaging of Skin In Vivo
|
||
Withdrawn |
NCT03357419 -
The Effect of Prophylactic Antibiotics on Surgical Site Infection Lower Limb Skin Excisions
|
N/A | |
Completed |
NCT02740257 -
Smartphone Application to Detect Skin Lesions
|
||
Recruiting |
NCT03796871 -
Medical Device Based on Polarized Light for Cutaneous Lesions Visualization
|
N/A | |
Completed |
NCT05238870 -
Prevention of Skin Damage in the Patient in Prone Position: Development of Education Interventions Based on a Training Needs Assessment Study.
|
||
Completed |
NCT05940090 -
Correlation of Dermatologist Made Biopsy Decision With AI Assisted Total Body Photography Detection of Outlier Lesions
|
||
Enrolling by invitation |
NCT04566302 -
Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy
|
N/A | |
Completed |
NCT04470466 -
Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser for Enlarged Facial Pores
|
N/A |