High Fluence Light Emitting Diode-Red Light (LED-RL) in Human Skin
Completed · Phase 1
Conditions studied: Fibrosis, Scarring, Scar, Wounds, Injuries, Keloid, Cicatrix, Hypertrophic
In brief
The goal of this study is to establish the safety of high fluence LED-RL from 160 J/cm2 up to 640 J/cm2 in healthy subjects. The hypothesis is that high fluence LED-RL phototherapy is safe in human skin.
Key facts
- Study ID
- NCT02630303
- Run by
- Jared Jagdeo, MD, MS
- People needed
- 60
- Starts
- 2016-01-01
- Expected to finish
- 2017-03-01
- Last updated by the study team
- 2017-03-31
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
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; 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
Where it is running
- Sacramento VA Medical Center — Mather, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.