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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT03888703
Eligibility Criteria:
Inclusion Criteria:
* Subject is between 18 and 80 years of age with burn injuries suffered within the prior 3 months
* Subject is a healthy Male or Female
* Fitzpatrick Skin Type I - IV
* Subject must have moderate - severe burn damage of sufficient bilateral area involving either the face, trunk, arms or legs
* Subject must be able to read, understand and sign the Informed Consent Form
* Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
* Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period
* Subject is willing to have photographs taken of the treated area which will be used de-identified in evaluations and may be used de-identified in presentations and/or publications
* For female candidates - they may be post-menopausal, surgically sterilized, or using a medically acceptable form of birth control during the entire course of the study.
* Female candidates with child bearing potential - willing to take pregnancy test and result must be negative.
Exclusion Criteria:
* Subject is less than 18 or greater than 80 years of age.
* Subject has Fitzpatrick Skin Type V - VI
* Subject is Pregnant or planning to become pregnant during the study duration
* Subject is breast feeding during the study duration
* Subject has an active skin infection, dermatitis or a rash in the treatment area
* Subject has a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications
* Subject has a known bleeding disorder
* Subject has a known photosensitivity to the study laser wavelength, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.
* Subject has a known collagen, vascular disease or scleroderma
* Subject has undergone any surgery or other procedures in the treatment area within 6 months of treatment which are still healing.
* Subject is suffering from significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy
* Subject is undergoing systemic chemotherapy for the treatment of cancer
* Subject has lesions suspicious for malignancy
* The systemic use of isotretinoin (Accutane®) or other retinoid derivatives within 6 months of study participation
* Any use of gold therapy for disorders such as rheumatologic disease or lupus
* The subject is excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study
* The subject has participated in a study of another device or drug within three months prior to enrollment or during the study.
* 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:
80 Years
Study:
NCT03888703
Study Brief:
Protocol Section:
NCT03888703