Status:
UNKNOWN
Phase 1 Study of HF-LED-RL in Fitzpatrick Skin Types I to III
Lead Sponsor:
VA Northern California Health Care System
Collaborating Sponsors:
East Bay Institute for Research and Education
Conditions:
Skin Diseases
Keloid
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 p...
Detailed Description
The effects of visible light, while common in the environment (visible spectrum accounts for 44% of total solar energy), remain undefined. An important safety feature of visible red light (600 nm to 7...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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"
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 8 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03433222
Start Date
January 31 2018
End Date
January 8 2019
Last Update
February 14 2018
Active Locations (1)
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1
Sacramento VA Medical Center
Mather, California, United States, 95655