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 @ 5:15 PM
Ignite Modification Date:
2025-12-24 @ 5:15 PM
NCT ID:
NCT02898350
Eligibility Criteria:
Inclusion Criteria:
* Comprehension of, and willingness to sign, the Informed Consent Form.
* Have a planned a surgical procedure, which is expected to result in a least one linear surgical scar of at least 3.0 cm.
* Be a healthy male or female of at least 18 years old.
* Fitzpatrick skin type I-V.
* Willingness to follow the treatment and follow-up schedule and the post-treatment care instructions.
* Non pregnant and/or breast feeding, if applicable.
* Willingness to provide a brief medical history including disclosure of any prescribed or over-the-counter medications taken within the past 6 months.
* Agree to follow and undergo all study-related procedures.
* Use of daily use of sunblock SPF 30 or higher for duration of the study.
Exclusion Criteria:
1. Pregnant and/or breastfeeding.
2. Fitzpatrick skin type VI.
3. Prior treatment for the surgical scar to be treated in this study.
4. Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
5. Use of Isotretinoin or other systemic retinoids within the past 6 months.
6. Use of topical retinoids or therapeutic topicals in the treatment area in past 2 months.
7. Use of medications that induce photosensitivity on the 595 and 10,600 nm wavelength ranges.
8. Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions.
9. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
10. Having any uncontrolled disease or disorder or one which per the investigator's judgment might make it unsafe for the subject to participate in this study.
11. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning and sun exposure for the duration of the study.
12. Participation in another investigational device or investigational drug study within 30 days prior to enrollment, as per the investigator's clinical judgment.
13. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02898350
Study Brief:
Protocol Section:
NCT02898350