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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT02630303
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects of any sex, ethnicity and age
* Nondominant proximal anterior forearm is wide enough to ensure reproducible placement of LED-RL phototherapy or mock therapy hand-held unit
* Available and willing to attend all clinic visits
* Able and willing to give informed consent
Exclusion Criteria:
* Subjects using any photosensitizers (i.e. lithium, melatonin, phenothiazine antipsychotics, antibiotics)
* Subjects with diabetes mellitus (DM)
* Subjects with a history of skin cancer; basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
* Subjects with systemic lupus erythematous (SLE)
* Subjects with any other medical condition that could be compromised by exposure to the proposed treatment
* Subjects with light-sensitive conditions or on photosensitizing medications (All subjects will be tested for photosensitivity per manufacturer user guide instructions)
* Subjects with open wounds on the nondominant proximal anterior forearm
* Subjects with fibrotic skin disease or other skin conditions on the nondominant proximal anterior forearm
* Subjects with tattoos that cover the procedure site on the nondominant proximal anterior forearm
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT02630303
Study Brief:
Protocol Section:
NCT02630303