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

"The maximum recommended starting dose (MSRD) (160 J/cm2) will be administered to Group 1's LED-RL phototherapy randomized subjects and the LED-RL dose will be escalated in subsequent groups using the classical method for dose escalation as described by Spilker: starting with dose (X) increased by an equal amount (in this instance: X=160 J/cm2, 2X=320 J/cm2, 3X=480 J/cm2, 4X=640 J/cm2). Common expected procedure side effects are mild and temporary, including warmth, redness (erythema) and swelling (edema). The maximally tolerated dose (MTD) is defined as the dose level below the dose producing unacceptable but reversible toxicity and is considered the upper limit of subject tolerance.~All subjects will receive total of nine LED-RL phototherapy, three times per week for three consecutive weeks."

"Mock therapy will be administered to mock therapy randomized subjects using the mock therapy unit and only generates warmth and does not emit LED-RL.~All subjects will receive total of nine mock therapy procedures, three times per week for three consecutive weeks."