Skin LesionNCT04539886
Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions
A study testing CellFX System and Intralesional Electrodesiccation in people with Skin Lesion and Skin Abnormalities, run by Pulse Biosciences, Inc. at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia
- What is being tested?
- CellFX System and Intralesional Electrodesiccation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Sep 2020to 18 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 21 and no older than 80 years of age.
- Subject gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subject must comply with study procedures including follow-up visits.
- Subject is willing to have SH lesions treated in a single treatment session and understands that their lesion(s) may undergo a second treatment session at a subsequent visit.
- Subject must have a minimum of four SH lesions and up to 10 SH lesions to be treated and the subject must have at least two SH lesions located on each side of the face.
- For study purposes, the SH lesions must be no greater than 2 mm in height and must not exceed 5 mm x 5 mm at their largest dimension. The subject's lesions cannot be located within the eye orbit, nose, or scalp.
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- Subject consents to have photographs taken of the SH lesion(s).
- Subject agrees to refrain from using all other lesion removal products or treatments (e.g. retinols, retinoids, and exfoliating products) to the treated SH lesions or any new SH lesions during the study period.
- Subject agrees to refrain from prolonged sun exposure during the study period.
Who cannot join
- Subject has an implantable electronic medical device.(i.e., pacemaker, implantable cardioverter defibrillator)
- Subject has an active infection or history of infection in designated test area within 90 days prior to first treatment.
- Subject is not willing or able to sign the Informed Consent.
- Subject is known to be immune compromised.
- Subject is prone to developing hypertrophic scars or to be a keloid producer.
- Subject has allergies to Lidocaine or Lidocaine-like products.
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- Subject is employed by the sponsor, clinic site, or entity associated with the conduct of the study.
- Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study.
- Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study.
- Subject was previously treated with CellFX for SH lesions.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, 28207
Zel Skin & Laser Specialists
Edina, Minnesota, 55424
Austin Institute for Clinical Research, Inc.
Houston, Texas, 77056
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
Investigate MD, LLC
Scottsdale, Arizona, 85255
About this study
Official title: A Multicenter, Prospective, Randomized, Comparison IDE Study Between the Pulse Biosciences CellFX System and Electrodessication (Hyfrecator Electrosurgical) for the Treatment of Sebaceous Hyperplasia (SH) Lesions
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.
Read the detailed description
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.
- Conditions
- Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia
- Being tested
- CellFX System, Intralesional Electrodesiccation
- Keywords
- CellFX, Nano-Pulse Stimulation, NPS, Clearance
- Medical subject headings
- Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellFX SystemDevice
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)
Intralesional ElectrodesiccationDevice
Hyfrecator electrosurgical unit with a non-insulated needle-shaped electrode
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CellFX System |
| 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. Receives: Device: Intralesional Electrodesiccation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 30 days post last CellFX or Electrodessication treatment, up to a maximum of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start28 Sep 2020
- Primary completion2 Feb 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulse Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Nuccitelli, PhD, Study chair, Pulse Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539886
- Sponsor's protocol ID
- NP-SC-012
- Status last verified
- Apr 2024
- First submitted
- 31 Aug 2020
- Last updated
- 25 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Comparison IDE Study Between the Pulse Biosciences CellFX System and Electrodessication (Hyfrecator Electrosurgical) for the Treatment of Sebaceous Hyperplasia (SH) Lesions
- ClinicalTrials.gov ID
- NCT04539886
- Acronym / sponsor ID
- NP-SC-012
- Conditions
- Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia
- Keywords
- CellFX, Nano-Pulse Stimulation, NPS, Clearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Posted 25 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CellFX System | Experimental | Device: CellFX SystemThe 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 | Device: Intralesional ElectrodesiccationIntralesional Electrodesiccation involves using a Hyfrecator electrosurgical unit and a non-insulated epilation needle electrode to apply a high-frequency electric current within the lesion. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is at least 21 and no older than 80 years of age.
- Subject gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subject must comply with study procedures including follow-up visits.
- Subject is willing to have SH lesions treated in a single treatment session and understands that their lesion(s) may undergo a second treatment session at a subsequent visit.
- Subject must have a minimum of four SH lesions and up to 10 SH lesions to be treated and the subject must have at least two SH lesions located on each side of the face.
Key exclusion criteria (10 listed)
- Subject has an implantable electronic medical device.(i.e., pacemaker, implantable cardioverter defibrillator)
- Subject has an active infection or history of infection in designated test area within 90 days prior to first treatment.
- Subject is not willing or able to sign the Informed Consent.
- Subject is known to be immune compromised.
- Subject is prone to developing hypertrophic scars or to be a keloid producer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CellFX SystemCellFX 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) | Device | CellFX System |
| Intralesional ElectrodesiccationHyfrecator electrosurgical unit with a non-insulated needle-shaped electrode | Device | Intralesional Electrodesiccation |
Primary outcome
Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS)
Time frame: 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.
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 With Hyperpigmentation, Hypopigmentation and Scarring as Assessed by Blinded Investigator During Live Assessments
Time frame: 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.
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 With Skin Textual Changes as Assessed by Blinded Investigator During Live Skin Assessment
Time frame: 30 days post last CellFX or Electrodessication treatment, up to a maximum of 2 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Nuccitelli, PhD study chair
Pulse Biosciences, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CellFX System and Intralesional Electrodesiccation in people with Skin Lesion and Skin Abnormalities, run by Pulse Biosciences, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS) (time frame: 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.