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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT06899958
Eligibility Criteria:
Inclusion Criteria:
1. 18- 60 years of age;
2. BMI between 25.0 and 30 kg/m2;
3. Subjects must be in good general health, based on answers provided during the screening visit;
4. Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol.
5. Females of childbearing potential must be willing and able to use a medically highly effective form of birth control during the entire study.
Exclusion Criteria:
1. Participation in another investigational drug or device clinical trial in the past 30 days;
2. Currently pregnant or pregnancy within the past 6 months or currently breastfeeding;
3. Have a history of drug or alcohol abuse in the past 3 years or have reported habitual alcohol intake greater than 2 standard drinks per day (e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks);
4. Planning or currently participating in a weight loss program;
5. Plan to change daily diet or level of physical activity;
6. Intake of medication that may affect body weight such as GLP-1 receptor agonists, amitriptyline, bupropion, thyroid medications, etc.;
7. History of cancer which required lymph node biopsy or dissection;
8. Weight loss or gain of 10 kg or more in the past 6 months;
9. History of diabetes mellitus or cardiac disease;
10. Intake of hormone replacement therapy (HRT) in the last 6 months;
11. Infection, surgery, or history of trauma or laser treatment to the treatment area in the past 6 months;
12. Presence of any skin disease on the abdomen or thighs;
13. Have birthmarks, tattoos, scars, or any other disfiguration of the skin in the abdomen or thighs;
14. Presence of sunburn or tan in the abdomen or thighs;
15. Use of any topical application of retinoids in the past 6 weeks on the abdomen or thighs or intake of systemic retinoids in the past 6 months;
16. Use of any prescription topical medication, such as corticosteroids or hydroquinone on the abdomen or thighs in the past 6 weeks;
17. History of keloid formation or hypertrophic scarring;
18. History of bariatric surgery or other major weight-loss procedures;
19. History of abdominal liposuction, abdominoplasty or CoolSculpting;
20. Known allergy to lidocaine or other local anesthetics;
21. The investigator believes that the subject is an unsuitable candidate to participate in the study, receive laser treatment, or would be placed at risk by participating in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06899958
Study Brief:
Protocol Section:
NCT06899958