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 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT05097157
Eligibility Criteria:
Inclusion Criteria:
* A healthy, non-smoking male or female between the age of 18-55 years old.
* Fitzpatrick skin type I to VI.
* Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
* Understands and accepts the obligation and is logistically able to be present for all visits.
* Is willing to comply with all requirements of the study and sign the informed consent document.
Exclusion Criteria:
* Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
* The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
* The subject has physical problems such as cardiovascular disorders.
* The subject has a pacemaker.
* The subject had previous use of gold thread skin rejuvenation.
* The subject has skin infections.
* The subject has any of the following conditions:
* Diabetes
* Epilepsy
* Acute disease
* Dermatitis
* Subjects with electronic implants such as cardiac defibrillator. It may interfere with operation of electronic implants or damage the implants, causing risks.
* The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05097157
Study Brief:
Protocol Section:
NCT05097157