NCT04539886

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Pulse Biosciences, Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Skin Lesion
• Skin Abnormalities
• Sebaceous Hyperplasia

Interventions

Type	Name	Description
DEVICE	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)
DEVICE	Intralesional Electrodesiccation	Hyfrecator electrosurgical unit with a non-insulated needle-shaped electrode

Timeline

• Start date: 2020-09-28
• Primary completion: 2021-02-02
• Completion: 2021-11-18
• First posted: 2020-09-07
• Last updated: 2024-04-25
• Results posted: 2024-04-25

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study