Wounds Clinical Trial
Official title:
Phase I Study of High Fluence Light Emitting Diode-Red Light (LED-RL) in Human Skin
Verified date | March 2017 |
Source | VA Northern California Health Care System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Sacramento VA Medical Center | Mather | California |
Lead Sponsor | Collaborator |
---|---|
Jared Jagdeo, MD, MS | East Bay Institute for Research and Education, VA Northern California Health Care System |
United States,
Jagdeo JR, Adams LE, Brody NI, Siegel DM. Transcranial red and near infrared light transmission in a cadaveric model. PLoS One. 2012;7(10):e47460. doi: 10.1371/journal.pone.0047460. Epub 2012 Oct 15. — View Citation
Lev-Tov H, Mamalis A, Brody N, Siegel D, Jagdeo J. Inhibition of fibroblast proliferation in vitro using red light-emitting diodes. Dermatol Surg. 2013 Aug;39(8):1167-70. doi: 10.1111/dsu.12212. — View Citation
Mamalis A, Jagdeo J. Light-emitting diode-generated red light inhibits keloid fibroblast proliferation. Dermatol Surg. 2015 Jan;41(1):35-9. doi: 10.1097/01.DSS.0000452650.06765.51. — View Citation
Sadick NS. A study to determine the efficacy of a novel handheld light-emitting diode device in the treatment of photoaged skin. J Cosmet Dermatol. 2008 Dec;7(4):263-7. doi: 10.1111/j.1473-2165.2008.00404.x. — View Citation
Sadick NS. Handheld LED array device in the treatment of acne vulgaris. J Drugs Dermatol. 2008 Apr;7(4):347-50. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of procedure-related common expected procedure outcomes and adverse events (safety and tolerability) | To evaluate safety of high fluence LED-RL Phototherapy by recording any common expected procedure outcomes [warmth, erythema (redness), and edema (swelling) that are mild, self-limited, and are expected to last less than 24 hours] and adverse events (including: second-degree or higher skin burning or blistering, erythema lasting more than 24 hours, severe swelling, pain, ulceration, change in sensation, and/or muscle weakness], via assessment during and immediately post-procedure, subject diary of adverse events and weekly phone calls) | 3 weeks |
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