Phase 1 Study of HF-LED-RL in Fitzpatrick Skin Types I to III
Status unconfirmed · Phase 1
Conditions studied: Skin Diseases, Keloid, Scar, Fibrosis, Hypertrophic Skin
In brief
The goal of this study is to establish the safety of high fluence LED-RL at fluence of 480 J/cm2 and 640 J/cm2 in healthy non-Hispanic, Caucasian subjects. The hypothesis is that high fluence LED-RL phototherapy is safe in non-Hispanic, Caucasians.
Key facts
- Study ID
- NCT03433222
- Run by
- VA Northern California Health Care System
- People needed
- 60
- Starts
- 2018-01-31
- Expected to finish
- 2019-01-08
- Last updated by the study team
- 2018-02-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy subjects of any sex and age
- Non-Hispanic, Caucasian race/ethnicity
- 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
You may not qualify if…
- Subjects using any photosensitizers (i.e. lithium, melatonin, phenothiazine antipsychotics, antibiotics)
- Subjects with diabetes mellitus (DM)
- Subjects with a history of skin cancer.
- Subjects with systemic lupus erythematous (SLE)
- Subjects with light-sensitive conditions (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
- Subjects of an ethnic race group other than Non-Hispanic, Caucasian
- Subjects who have previously participated in the VA Northern California's "Phase 1 Study of LED-RL in Human Skin"
Where it is running
- Sacramento VA Medical Center — Mather, California, United States (enrolling)
Full record on ClinicalTrials.gov
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