Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions (NCT04539886) | Clinical Trial Compass
CompletedNot Applicable
Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions
United States60 participantsStarted 2020-09-28
Plain-language 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.
Who can participate
Age range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Lesions With Improvement as Assessed With the Global Aesthetic Improvement Scale (GAIS)
Timeframe: 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.
2
Percentage of Lesions With Hyperpigmentation, Hypopigmentation and Scarring as Assessed by Blinded Investigator During Live Assessments
Timeframe: 60 days post last CellFX or Electrodessication treatment, up to a maximum of 3 months.
3
Percentage of Lesions With Skin Textual Changes as Assessed by Blinded Investigator During Live Skin Assessment
Timeframe: 30 days post last CellFX or Electrodessication treatment, up to a maximum of 2 months