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This study is designed as a multi-center, single-blinded, prospective, randomized, study to compare the safety and effectiveness of the CellFX System to the comparator group, Electrodessication for the treatment of SH lesions in healthy adult subjects.
This SH comparative study will evaluate safety and efficacy in a split face design using the CellFX System and pre-defined energy profile for all primary and secondary treatments based on Fitzpatrick Skin Types and tip size. The comparator group will be treated with the same standardized intralesional electrodesiccation procedure conducted by all participating clinical sites. Subjects with 4-10 qualifying SH lesions on the face except the scalp, nose and within the orbital region will be enrolled. Each subject will be evaluated by the blinded site investigator at 7-days, 30-days, and 60-days post-initial CellFX and Electrodessication treatments. At the 30-day follow-up visit, lesions will be evaluate using Global Aesthetic Improvement Scale (GAIS), for eligibility to receive an additional treatment. In case of a second treatment, the subject will be evaluated by the blinded site investigator at 30-days and 60-days post-retreatment. Photography of the study lesions will be captured along with the blinded site investigator assessments at all visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CellFX System | Experimental | The CellFX System consists of a electrical pulse console combined with a handpiece coupled with a sterile single patient-use treatment tip (1.5 x 1.5mm, 2.5 x 2.5mm, and 5.0 x 5.0mm). Based on the size of the SH lesion and treatment tip used, a predetermined treatment energy setting is selected to deliver a sequence of electrical pulses to the SH lesion area directly beneath the treatment tip. |
|
| Intralesional Electrodesiccation | Active Comparator | Intralesional Electrodesiccation involves using a Hyfrecator electrosurgical unit and a non-insulated epilation needle electrode to apply a high-frequency electric current within the lesion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CellFX System | Device | CellFX System consists of a console combined with a handpiece and coupled with a sterile single patient-use treatment tip (1.5 x 1.5mm, 2.5 x 2.5mm, and 5.0 x 5.0mm) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS) | Percentage of SH Lesions with Improvement as Assessed by Blinded Investigator During Live Assessments based on Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale ranges from 1=Very Much Improved or Excellent Corrective Result to 5=Worsened Appearance Compared with Original Condition. The primary effectiveness endpoint of improvement at 60-days post-last treatment as assessed "live" by the blinded site investigator using the 5-point GAIS | 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months. |
| Percentage of Lesions With Hyperpigmentation, Hypopigmentation and Scarring as Assessed by Blinded Investigator During Live Assessments | The first co-primary safety endpoint includes the percentage of lesions showing hyperpigmentation and scarring as assessed by the blinded Investigator at 60 days after the last treatment with CellFX or Electrodessication | 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months. |
| Percentage of Lesions With Skin Textual Changes as Assessed by Blinded Investigator During Live Skin Assessment | The second co-primary safety endpoint of skin textural changes including; flaking, erythema, crusting, scabbing, or other skin irregularities was assessed by the blinded site investigator at 30 days post last CellFX or Electrodessication treatment. | 30 days post last CellFX or Electrodessication treatment, up to a maximum of 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Nuccitelli, PhD | Pulse Biosciences, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigate MD, LLC | Scottsdale | Arizona | 85255 | United States | ||
| Zel Skin & Laser Specialists |
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Not applicable, since randomization occurred at the time of enrollment, defined as the time when intervention of the device occurred.
This study was a prospective, randomized, single-blinded, split-face design in a total of 60 participants with a minimum of 4 and a maximum of 10 SH lesions.
| ID | Title | Description |
|---|---|---|
| FG000 | Participants Treated With CellFX System | The CellFX System consists of an electrical pulse console (similar to devices used to electro-coagulate tissue) combined with a handpiece which is held by the clinician during application of pulses directly to the skin surface. The handpiece is coupled to a sterile, single patient-use non-insulated treatment tip. Once the electrical pulse console is turned on and a predetermined treatment energy setting is selected, a sequence of preprogrammed electrical pulses is administered to an area of skin directly beneath the treatment tip. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2020 |
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Subjects will be randomized to receiving the two treatments in a split-face design with CellFX being used on only one side of the face and Electrodessication on the other side. The randomization assignment will include the type of treatment and which side of the face.
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The Principal Investigator will select a sub investigator to be the blinded investigator to classify healing characteristics and aesthetic appearance of each subject's selected lesions at baseline and treated lesions post treatment and at 7-days, 30-days, and 60-days following the last CellFX treatment or Electrodessication. This sub investigator will be blinded to the treatment assignment. The subject may not be blinded to the treatment assignment.
| Intralesional Electrodesiccation | Device | Hyfrecator electrosurgical unit with a non-insulated needle-shaped electrode |
|
| Edina |
| Minnesota |
| 55424 |
| United States |
| Dermatology, Laser & Vein Specialists of the Carolinas, PLLC | Charlotte | North Carolina | 28207 | United States |
| Austin Institute for Clinical Research, Inc. | Houston | Texas | 77056 | United States |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78660 | United States |
| FG001 | Participants Treated With Intralesional Electrodessication | Intralesional Electrodessication involves using a Hyfrecator electrosurgical unit and a non-insulated epilation needle electrode to apply a high-frequency electric current within the lesion. Intralesional Electrodessication: Hyfrecator electrosurgical unit with a non-insulated needle-shaped electrode |
| COMPLETED |
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| NOT COMPLETED |
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The Study Design was a split-face design, so all 60 participants are presented in the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants received prospective, randomized, single-blinded treatments using the CellFX System and Intralesional Electrodessication in a split-face study design. Participants were randomized to receive an initial treatment and a possible secondary treatment at 30 days with either the CellFX System on 1 side of the face and electrodessication on the other side. The CellFX System consists of an electrical pulse console (similar to devices used to electro-coagulate tissue) combined with a handpiece which is held by the clinician during application of pulses to the skin surface. The handpiece is coupled to a sterile, single patient-use non-insulated treatment tip. Once the electrical pulse console is turned on and a predetermined treatment energy setting is selected, a sequence of preprogrammed electrical pulses is administered to an area of skin directly beneath the treatment tip. The active comparator was electrodessication using the Hyfrecator electrosurgical unit with a non-insulated needle-shaped tip. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Fitzpatrick Skin Type Class | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS) | Percentage of SH Lesions with Improvement as Assessed by Blinded Investigator During Live Assessments based on Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale ranges from 1=Very Much Improved or Excellent Corrective Result to 5=Worsened Appearance Compared with Original Condition. The primary effectiveness endpoint of improvement at 60-days post-last treatment as assessed "live" by the blinded site investigator using the 5-point GAIS | 2.5mm SH lesions were assessed at 60-days post-last treatment of the lesion with either CellFX or Electrodessication by blinded Investigator during live assessments using Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale ranges from 1=Very Much Improved or Excellent Corrective Result to 5=Worsened Appearance Compared with Original Condition. | Posted | Number | 95% Confidence Interval | percentage of lesions | 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months. | Lesions | Lesions |
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| Primary | Percentage of Lesions With Hyperpigmentation, Hypopigmentation and Scarring as Assessed by Blinded Investigator During Live Assessments | The first co-primary safety endpoint includes the percentage of lesions showing hyperpigmentation and scarring as assessed by the blinded Investigator at 60 days after the last treatment with CellFX or Electrodessication | Subjects with 2.5mm lesions | Posted | Number | 95% Confidence Interval | percentage of lesions | 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months. | lesions | lesions |
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Lesions With Skin Textual Changes as Assessed by Blinded Investigator During Live Skin Assessment | The second co-primary safety endpoint of skin textural changes including; flaking, erythema, crusting, scabbing, or other skin irregularities was assessed by the blinded site investigator at 30 days post last CellFX or Electrodessication treatment. | Subjects with 2.5mm lesions with Pre-specified safety margin (95% CIU<15%) | Posted | Number | 95% Confidence Interval | percentage of lesions | 30 days post last CellFX or Electrodessication treatment, up to a maximum of 2 months | lesions | lesions |
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through study completion, an average of 6 months
Percent of non-serious AEs are reported per participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Treated With CellFX System | The CellFX System consists of a electrical pulse console combined with a handpiece coupled with a sterile single patient-use treatment tip (1.5 x 1.5mm, 2.5 x 2.5mm, and 5.0 x 5.0mm). Based on the size of the SH lesion and treatment tip used, a predetermined treatment energy setting is selected to deliver a sequence of electrical pulses to the SH lesion area directly beneath the treatment tip. CellFX System: CellFX System consists of a console combined with a handpiece and coupled with a sterile single patient-use treatment tip (1.5 x 1.5mm, 2.5 x 2.5mm, and 5.0 x 5.0mm) | 0 | 59 | 0 | 59 | 3 | 59 |
| EG001 | Participants Treated With Intralesional Electrodesiccation | Intralesional Electrodesiccation involves using a Hyfrecator electrosurgical unit and a non-insulated epilation needle electrode to apply a high-frequency electric current within the lesion. Intralesional Electrodesiccation: Hyfrecator electrosurgical unit with a non-insulated needle-shaped electrode | 0 | 59 | 0 | 59 | 0 | 59 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swelling | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment | Mild swelling at site of lesion treatment that resolved within 7 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William A. Knape, VP Clinical, Regulatory and Quality Affairs | Pulse Biosciences, Inc. | 510-906-4649 | bknape@pulsebiosciences.com |
| Jul 5, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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