N/A
Completed N=120
Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions
Skin Lesion · Skin Abnormalities · Sebaceous Hyperplasia
Source: ClinicalTrials.gov NCT04539886 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS) — 76.2; 75.5 percentage of lesions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS) |
76.2; 75.5 | — |
| PRIMARY Percentage of Lesions With Hyperpigmentation, Hypopigmentation and Scarring as Assessed by Blinded Investigator During Live Assessments |
15.1; 11.1 | — |
| PRIMARY Percentage of Lesions With Skin Textual Changes as Assessed by Blinded Investigator During Live Skin Assessment |
6.87; 10.2 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04539886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.