An interventional study of CellFX System and Intralesional Electrodesiccation in Skin Lesion, Skin Abnormalities and Sebaceous Hyperplasia, sponsored by Pulse Biosciences, Inc.. Completed at 5 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by Pulse Biosciences, Inc. · Not applicable, Interventional, and Treatment
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.
39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.
This study's enrollment of 60 is above the median of 39 across 26 interventional studies indexed under Skin Abnormalities.
Browse Skin Abnormalities studies →Pulse Biosciences, Inc. is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: CellFX System
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.
Device: Intralesional Electrodesiccation
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)
Hyfrecator electrosurgical unit with a non-insulated needle-shaped electrode
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
Time frame: 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
Time frame: 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.
Time frame: 30 days post last CellFX or Electrodessication treatment, up to a maximum of 2 months
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.
| Milestone | Participants Treated With CellFX System | Participants Treated With Intralesional Electrodessication |
|---|---|---|
| Started | 60 | 60 |
| Completed | 60 | 60 |
| Not completed | 0 | 0 |
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
| percentage of lesions | Participants Treated With CellFX System | Participants Treated With Intralesional Electrodessication |
|---|---|---|
| Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS) | 76.2 (67.0 to 85.5) | 75.5 (66.6 to 84.4) |
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
| percentage of lesions | Participants Treated With CellFX System | Participants Treated With Intralesional Electrodessication |
|---|---|---|
| Percentage of Lesions With Hyperpigmentation, Hypopigmentation and Scarring as Assessed by Blinded Investigator During Live Assessments | 15.1 (7.68 to 22.40) | 11.1 (5.19 to 17.0) |
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.
| percentage of lesions | Participants Treated With CellFX System | Participants Treated With Intralesional Electrodessication |
|---|---|---|
| Percentage of Lesions With Skin Textual Changes as Assessed by Blinded Investigator During Live Skin Assessment | 6.87 (2.12 to 11.6) | 10.2 (3.84 to 16.6) |
Collected over through study completion, an average of 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants Treated With CellFX System | 0/59 (0%) | 0/59 (0%) | 3/59 (5.1%) |
| Participants Treated With Intralesional Electrodesiccation | 0/59 (0%) | 0/59 (0%) | 0/59 (0%) |
| Event | Participants Treated With CellFX System | Participants Treated With Intralesional Electrodesiccation |
|---|---|---|
| SwellingSkin and subcutaneous tissue disorders | 3/59 | 0/59 |
The Study Design was a split-face design, so all 60 participants are presented in the baseline analysis population.
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 55.2 ± 10 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 48 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 56 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 55 |
| More than one race | 2 |
| Unknown or Not Reported | 2 |
| Fitzpatrick Skin Type Class(Participants) | All Participants |
|---|---|
| Class II | 46 |
| Class III | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Pulse Biosciences, Inc.