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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT06317766
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female adults between 18-75 years of age.
* Subjects who can read, understand, and sign the Informed Consent Form.
* Subjects willing and able to comply with all study requirements.
* Fitzpatrick skin types I-IV.
* Subjects who have pre-scheduled a body or facial contouring procedure.
Exclusion Criteria:
* Subjects with active localized or systemic infections
* Immunocompromised subjects
* Subjects with coagulation disorder
* History of radiation therapy to treatment area
* Subject with a history of lidocaine or ester-based local anesthetics
* Pacemaker or internal defibrillator
* Superficial or metal implants in the area
* Current or history of skin cancer, as well as any other type of cancer, or pre-malignant moles.
* Severe concurrent conditions, such as cardiac disorders
* Pregnancy and nursing
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
* Diseases which may be stimulated by light at the wavelengths used, such as history of Systemic Lupus Erythematosus, Porphyria, and Epilepsy.
* Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.
* Any active 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.
* Use of medication and herbs known to induce photosensitivity to light exposure at the wavelengths used, such as Isotretinoin (Accutane) within the last 6 months, tetracyclines, or St. John's Wort within the last two weeks.
* Any surgical procedure in the treatment area within the last 3 months or before complete healing.
* Tattoo or permanent makeup in the treatment area.
* Excessively tanned skin from sun, tanning beds or tanning creams within last the two weeks.
* As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06317766
Study Brief:
Protocol Section:
NCT06317766