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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT03171051
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult, male or female, ≥ 18 years of age or older with skin types 1-VI.
* Having moderate excess bilateral fatty tissue of the flanks, suitable area for non-invasive lipolysis.
* Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control for at least three months prior to enrolment and throughout the course of the study and have a negative urine pregnancy test at baseline.
Exclusion Criteria:
* Pregnant, expectation of pregnancy, postpartum or nursing (\<6 months).
* History of skin disease in the area to be treated over the last 6 months.
* Previous surgical intervention to the treatment area.
* History of skin cancer or pre-cancerous lesions at the treatment areas.
* Having any electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
* History of immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
* Uncontrolled systemic diseases such as diabetes.
* Active infections in the treatment area.
* History of dysplastic nevi.
* Significant concurrent skin conditions or any inflammatory skin conditions.
* Active herpes simplex infections (e.g. cold sores), open lacerations or abrasions in the treatment area.
* Chronic or cutaneous viral, fungal, or bacterial diseases.
* Use of Accutane™ (Isotretinoin) within the past six months.
* Keloid or hypertrophic scar formation in the treatment area.
* Tattoos in the treatment area.
* History of auto-immune disorders.
* Erythema abigne, when identified treatments should be discontinued.
* History of photosensitivity disorder that can be exacerbated by laser or intense light.
* Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light.
* History of poor wound healing in the treatment area.
* Sunburns.
* Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a month) and during the course of the evaluation.
* Prior skin treatment with laser or other devices on the same treatment area within the last six months prior to study enrollment or during the course of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03171051
Study Brief:
Protocol Section:
NCT03171051