Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT04738734
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be at least 21 and not older than 80 years of age
* Subject has a Fitzpatrick Skin Type I, II, III or IV.
* 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 all follow-up visits.
* Subject is willing to have warts treated in a single treatment session and understands that their warts may undergo multiple treatment sessions at subsequent visits.
* Subject must have a minimum of 2 warts and up to 8 warts to be treated.
* Subject with a clinical diagnosis of common warts located on hands and fingers or other body areas that are not located on the scalp, nose, within the orbital region of the face, plantar, genital or periungual area.
* For study purposes, the warts must be no greater than 3 mm in height and must not exceed 10mm x 10mm at their largest dimension.
* Each wart must appear alone and discrete and not appear in clusters.
* Each wart must have been present for at least 4 weeks.
* Subject consents to have photographs taken of the warts.
* Subject agrees to refrain from using all other wart removal products or treatments (e.g.
topical medication including over-the-counter medications) during the study period.
Exclusion Criteria:
* Subject with more than 8 visible warts in total anywhere on the body.
* Subject has flat, periungual, subungual, genital, anal, mosaic, plantar or filiform warts.
* 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 taking antihistamines, including those used for gastric symptoms.
* Subject is prone to Koebnerization or has any of the following conditions (e.g., psoriasis, vitiligo, lichen planus, or an autoimmune disorder of the skin)
* Subject is not willing or able to sign the Informed Consent.
* Subject is known to be immune compromised.
* Subject has allergies to Lidocaine or Lidocaine-like products.
* Subject is a member of a vulnerable population including individuals 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 warts.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
80 Years
Study:
NCT04738734
Study Brief:
Protocol Section:
NCT04738734