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:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT06645366
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female subjects over 30 years of age seeking treatment for improvement in skin quality and texture on face and neck
* Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
* Subjects willing and able to abstain from partaking in any facial or neck treatments other than the study procedure during study participation
* Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face and neck without makeup taken
Exclusion Criteria:
* Local bacterial or viral infection in the area to be treated
* Local acute inflammation in the area to be treated
* Impaired immune system caused by any immunosuppressive illness, disease or medication
* Isotretinoin and tretinoin-containing medication use in the past 12 months
* Skin related autoimmune diseases
* Radiation therapy and/or chemotherapy
* Poor healing and unhealed wounds in the treatment area
* Metal implants near the treatment area or neutral electrode
* Permanent implant in the treated area
* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
* Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
* History of any type of cancer
* Active collagen diseases
* Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis, and thrombosis)1
* Pregnancy/nursing or IVF procedure
* History of bleeding coagulopathies, use of anticoagulants
* Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
* Any surgical procedure in the treatment area within the last three months or before complete healing
* Poorly controlled endocrine disorders, such as diabetes
* Tuberculosis
* Hepatitis
* Febrile conditions
* Unwillingness/inability to not change their usual cosmetics and especially not to use anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
* History of skin disorders, keloids, abnormal wound healing and dry or fragile skin
* Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks
* Neurotoxin/collagen/fat injections or other injected bio-material in the treated area within three months prior to the treatment
* Use of non-steroidal anti-inflammatory drugs one week before and after each treatment session
* Treating over tattoo or permanent make-up
* Treating over eyelids or the lips
* Patients with allergy to anesthetics
* Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
* Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT06645366
Study Brief:
Protocol Section:
NCT06645366