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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT02452359
Eligibility Criteria:
Inclusion Criteria:
1. Able to provide written Informed Consent;
2. Healthy male or female, 24-65 years Fitzpatrick-Goldman skin type I-V;
3. Having visible Striae Distensae to be treated (abdomen/thighs);
4. Comply with the treatment/follow-up schedule and requirements;
5. Women of child-bearing age are required to be using a reliable method of birth control
Exclusion Criteria:
1. Fitzpatrick-Goldman skin type VI;
2. Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after breastfeeding;
3. Heavy smoker
4. Unable or unlikely to refrain from tanning
5. Use of photosensitive medication
6. Use of oral isotretinoin within 3 months
7. Any dermal/epidermal damage or disorder in treated area
8. Prior treatment in treated area within 3 months
9. Prior skin laser/light or another device treatment in treated area within 6 months
10. Prior use of collagen, fat injections or other methods of skin augmentation in treated area within 12 months
11. Prior use of Botox in treatment area within 6 months
12. Prior ablative resurfacing procedure with laser in treatment area within 12 months
13. Any other surgery in treated area within 9 months
14. Participation in a study of another investigational device or drug as per the Investigator's discretion
15. History of keloid or any other type of hypertrophic scar formation or poor wound healing in a previously injured skin area
16. Showing symptoms of hormonal disorders (such as Melasma, Chloasma);
17. Concurrent inflammatory skin conditions, open laceration or abrasion of any sort on area to be treated during the course of treatment
18. Active Herpes Simplex at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study
19. Multiple dysplastic nevi in area to be treated
20. Having a bleeding disorder or taking anticoagulation medications
21. History of immunosuppression/immune deficiency disorders
22. Having any form of active cancer at the time of enrollment and during the course of the study or history of skin cancer
23. Pigmented lesion in the treated area that appears cancerous
24. Significant concurrent illness, such as uncontrolled diabetes
25. Active infections in the treated area
28.Tattoo or permanent makeup at the treatment area. 29.Mentally incompetent, prisoner or evidence of active substance or alcohol abuse 30.Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
24 Years
Maximum Age:
65 Years
Study:
NCT02452359
Study Brief:
Protocol Section:
NCT02452359