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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT03002194
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult female subject, 18 years of age and older with Fitzpatrick skin types I-IV
* Ability to tolerate the RF/PEMF procedure, and willing to adhere to the treatment regimen
Exclusion Criteria:
* Having any active electrical implant or permanent implant anywhere in the body, e.g. pacemaker, internal defibrillator
* Prior use of retinoids in treated area within 2 weeks of initial treatment
* Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment
* Patient on systemic corticosteroid therapy 6 months prior to start of study
* Prior use of collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 4-6 weeks of initial treatment. Treatment may not be performed at all over permanent dermal implants.
* Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment
* Any other surgery in treated area within 12 months of initial treatment
* History of keloid formation or poor wound healing in a previously injured skin area
* Epidermal or dermal disorders
* Open laceration or abrasion of any sort on the area to be treated.
* History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
* Having any form of active cancer at the time of enrollment
* Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the treatment, or healing process
* Participation in a study of another device or drug within 1 month prior to study enrollment
* Tattoos in the treatment area.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03002194
Study Brief:
Protocol Section:
NCT03002194