High Fluence Light Emitting Diode-Red Light (LED-RL) in Human Skin

Skin fibrosis is involved in a variety of pathologic processes ranging from exuberant scar
formation secondary to surgery or trauma, as in hypertrophic and keloid scars, to
immune-mediated processes such as scleroderma and chronic graft-versus-host disease. As
highlighted by quality-of-life studies, skin fibrosis imparts a significant socioeconomic
burden due to the functional, aesthetic, and psychosocial impact it has on a patient's life.
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 700 nm) is that it does not generate pro-carcinogenic DNA damage as does
ultraviolet (UV) light. Recently published clinical observations indicate that red light in
combination with other modalities such as photosensitizers in combined red light
photodynamic therapy can lessen skin fibrosis. However, preliminary in vitro data generated
by the investigator's research group suggests that red light can function as a stand-alone
treatment, eliminating the side-effects of chemical photosensitizers and the potential
long-term harm of current UV therapy. Furthermore, commercially available light emitting
diode-red light (LED-RL) units exist and are already FDA-cleared for other dermatological
uses (such as rhytides and acne), thus clinical translation for use in skin fibrosis could
occur relatively quickly following safety and efficacy demonstration. Developing high
fluence LED-RL phototherapy as a treatment for skin fibrosis would represent an important
advance in scarring conditions that lacks the serious systemic side effects associated with
immunomodulatory agents (such as oral steroids); avoids the need for invasive, painful
injections with anti-fibrotic agents (such as intralesional steroids, 5-fluorouracil and
bleomycin); and eliminates the UV-induced DNA damage associated with skin cancer and
photoaging that are associated with current UVA/UVA1 and UVB/narrowband UVB phototherapy. To
the investigator research group's knowledge, no clinical trials have been performed to
determine the safety of high fluence LED-RL for treatment of skin fibrosis. Therefore, the
innovation of this approach is that the investigator research group intend to study high
fluence LED-RL as a safe modality for treatment of skin fibrosis.

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