NCT04539886

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

Completed NA Results posted Last updated 25 April 2024

What this trial tests

NA trial testing CellFX System in Skin Lesion in 60 participants. Completed in 18 November 2021.

Timeline

28 September 2020

Primary endpoint
2 February 2021

18 November 2021

Quick facts

Lead sponsor	Pulse Biosciences, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	28 September 2020
Primary completion	2 February 2021
Estimated completion	18 November 2021
Sites	5 locations across United States

Drugs / interventions tested

• CellFX System
• Intralesional Electrodesiccation

Conditions studied

• Skin Lesion — all drugs for Skin Lesion →
• Skin Abnormalities — all drugs for Skin Abnormalities →
• Sebaceous Hyperplasia — all drugs for Sebaceous Hyperplasia →

Sponsor

Pulse Biosciences, Inc.

Who can join

Adults 21 to 80, any sex, with Skin Lesion or Skin Abnormalities. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS) Primary · 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

Group	Value	95% CI
Participants Treated With CellFX System	76.2	67.0 – 85.5
Participants Treated With Intralesional Electrodessication	75.5	66.6 – 84.4

Percentage of Lesions With Hyperpigmentation, Hypopigmentation and Scarring as Assessed by Blinded Investigator During Live Assessments Primary · 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

Group	Value	95% CI
Participants Treated With CellFX System	15.1	7.68 – 22.40
Participants Treated With Intralesional Electrodessication	11.1	5.19 – 17.0

Percentage of Lesions With Skin Textual Changes as Assessed by Blinded Investigator During Live Skin Assessment Primary · 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.

Group	Value	95% CI
Participants Treated With CellFX System	6.87	2.12 – 11.6
Participants Treated With Intralesional Electrodessication	10.2	3.84 – 16.6

Adverse events — posted to ClinicalTrials.gov

Time frame: through study completion, an average of 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants Treated With CellFX System

Serious: 0/59 (0%)

Deaths: 0/59

Participants Treated With Intralesional Electrodesiccation

Serious: 0/59 (0%)

Deaths: 0/59

Other adverse events (1 terms — click to expand)

Reaction	System	Participants Treated With …	Participants Treated With …
Swelling	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT04539886 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.