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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT01559233
Eligibility Criteria:
Inclusion Criteria:
* Subjects with mild to moderate facial wrinkles and rhytides .
* Males and females 21 - 65 years of age.
* Willingness to follow the treatment schedule, and have photographs taken.
Exclusion Criteria:
* Pacemaker or internal defibrillator, or other implanted metallic or electronic device.
* Permanent implant in the treated area such as metal plates and screws or silicon, unless deep enough in the periosteal plane.
* Avoid treatment if intra-dermal or superficial sub-dermal areas have been injected with Botox/HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months.
* Current or history of skin cancer, or any other type of cancer, or pre-malignant moles.
* Severe concurrent conditions, such as cardiac disorders.
* Pregnancy or nursing.
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
* Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.
* Poorly controlled endocrine disorders, such as diabetes.
* Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* History of bleeding coagulopathies, or use of anticoagulants in the last 10 days.
* Any facial surgery performed within 12 months prior to treatment.
* Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3 months.
* Having received treatment with light, laser, RF, or other devices in the treated area within 6 months.
* Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
* Treating over tattoo or permanent makeup.
* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01559233
Study Brief:
Protocol Section:
NCT01559233