Trial Outcomes & Findings for Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions (NCT NCT04539886)

Last Updated: 2024-04-25

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.

Results posted on

2024-04-25

Participant Flow

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.

Not applicable, since randomization occurred at the time of enrollment, defined as the time when intervention of the device occurred.

Unit of analysis: SH Lesions

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	60 188	60 190
Overall Study COMPLETED	60 187	60 189
Overall Study NOT COMPLETED	0 1	0 1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=60 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.
Age, Continuous	55.2 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Fitzpatrick Skin Type Class Class II	46 Participants n=5 Participants
Fitzpatrick Skin Type Class Class III	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants Treated With CellFX System n=121 Lesions 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.	Participants Treated With Intralesional Electrodessication n=106 Lesions 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
Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS)	76.2 percentage of lesions Interval 67.0 to 85.5	75.5 percentage of lesions Interval 66.6 to 84.4

PRIMARY outcome

Timeframe: 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.

Population: Subjects with 2.5mm lesions

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

Outcome measures

Outcome measures
Measure	Participants Treated With CellFX System n=120 lesions 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.	Participants Treated With Intralesional Electrodessication n=107 lesions 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
Percentage of Lesions With Hyperpigmentation, Hypopigmentation and Scarring as Assessed by Blinded Investigator During Live Assessments	15.1 percentage of lesions Interval 7.68 to 22.4	11.1 percentage of lesions Interval 5.19 to 17.0

PRIMARY outcome

Timeframe: 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%)

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.

Outcome measures

Outcome measures
Measure	Participants Treated With CellFX System n=118 lesions 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.	Participants Treated With Intralesional Electrodessication n=107 lesions 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
Percentage of Lesions With Skin Textual Changes as Assessed by Blinded Investigator During Live Skin Assessment	6.87 percentage of lesions Interval 2.12 to 11.6	10.2 percentage of lesions Interval 3.84 to 16.6

Adverse Events

Participants Treated With CellFX System

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Participants Treated With Intralesional Electrodesiccation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants Treated With CellFX System n=59 participants at risk 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)	Participants Treated With Intralesional Electrodesiccation n=59 participants at risk 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
Skin and subcutaneous tissue disorders Swelling	5.1% 3/59 • Number of events 3 • through study completion, an average of 6 months Percent of non-serious AEs are reported per participants	0.00% 0/59 • through study completion, an average of 6 months Percent of non-serious AEs are reported per participants

Additional Information

William A. Knape, VP Clinical, Regulatory and Quality Affairs

Pulse Biosciences, Inc.

Phone: 510-906-4649

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60