Sebaceous Hyperplasia, Skin Abnormalities, Skin Lesion
Conditions
Keywords
CellFX, Nano-Pulse Stimulation, NPS, Clearance
Brief 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.
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.
Interventions
DEVICECellFX 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)
DEVICEIntralesional Electrodesiccation
Hyfrecator electrosurgical unit with a non-insulated needle-shaped electrode
Sponsors
Pulse Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS) | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Not applicable, since randomization occurred at the time of enrollment, defined as the time when intervention of the device occurred.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type Class Class II | 46 Participants |
| Fitzpatrick Skin Type Class Class III | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 55 Participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 59 |
| other Total, other adverse events | 3 / 59 | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 |
Outcome results
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
Time frame: 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.
Population: Subjects with 2.5mm lesions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Treated With CellFX System | Percentage of Lesions With Hyperpigmentation, Hypopigmentation and Scarring as Assessed by Blinded Investigator During Live Assessments | 15.1 percentage of lesions |
| Participants Treated With Intralesional Electrodessication | Percentage of Lesions With Hyperpigmentation, Hypopigmentation and Scarring as Assessed by Blinded Investigator During Live Assessments | 11.1 percentage of lesions |
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
Time frame: 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Treated With CellFX System | Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS) | 76.2 percentage of lesions |
| Participants Treated With Intralesional Electrodessication | Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS) | 75.5 percentage of 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.
Time frame: 30 days post last CellFX or Electrodessication treatment, up to a maximum of 2 months
Population: Subjects with 2.5mm lesions with Pre-specified safety margin (95% CIU\<15%)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Treated With CellFX System | Percentage of Lesions With Skin Textual Changes as Assessed by Blinded Investigator During Live Skin Assessment | 6.87 percentage of lesions |
| Participants Treated With Intralesional Electrodessication | Percentage of Lesions With Skin Textual Changes as Assessed by Blinded Investigator During Live Skin Assessment | 10.2 percentage of lesions |