Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks.

Cellulite is a common term used to describe superficial pockets of trapped fat, which causes
uneven dimpling or "orange peel" skin. It appears in 90% of post-adolescent women. In
advanced stages of cellulite, heaviness and pain may occur.

Currently available treatments for cellulite have minimal to no demonstrable effect and some
involve risky invasive procedures. Therefore, the potential advantages of the application of
low level laser light therapy to reduce the appearance of cellulite over current treatment
options include a risk free procedure that is non-invasive and pain free. Since low level
laser light within the green spectrum has been proven to increase the synthesis of collagen,
it is believed that its application may serve to decrease the appearance of cellulite by
tightening the skin. Moreover, newly synthesized collagen may alter the irregular pattern of
the connective tissue responsible for the formation of cellulite.

Inclusion Criteria:

- Areas for which cellulite appearance reduction is being sought are the bilateral
thighs and buttocks

- Clinical cellulite gradation of Stage II or III on the Nurnberger-Muller scale for
each treatment area

- PI or P2 on the American Society of Anesthesiologists (ASA) Physical Status
Classification System

- Willing and able to abstain from partaking in any treatment other than the study
procedure to promote cellulite appearance reduction/body contouring/weight loss
during the study

- Willing and able to maintain regular diet and exercise regimen without effecting
significant change in either direction during the study

- Willing and able to maintain regular medication schedule, as is medically feasible,
during the study

Exclusion Criteria:

- Clinical cellulite gradation of Stage 0 or I on the Nurnberger Muller Scale (NMS) for
either one or both thighs/buttocks

- P3 or P4 or P5 or P6 on the ASA Physical Status Classification System

- Weight fluctuation greater than 10 pounds in the prior month

- Previous attempt(s) to reduce cellulite in the study treatment areas over the past 6
months

- Prior surgical intervention to the treatment areas, for any reason

- Medical, physical or other contraindications for cellulite reduction/body
contouring/weight loss

- Current use of medication(s) known to affect weight levels and/or cause bloating or
swelling and for which abstinence during the study is not safe or medically prudent

- Any medical condition known to affect weight levels, cause bloating or swelling

- Diagnosis of, and/or taking medication for, irritable bowel syndrome

- Active infection, wound or other external trauma to the study treatment areas

- Dermatitis or significant scarring in the study treatment areas

- Medical, physical, or other contraindications for, or known sensitivity to, light
therapy

- Diabetes dependent on insulin or oral hypoglycemic medications

- Known cardiovascular disease

- Cardiac surgeries

- History of deep venous thrombosis, arterial disease of the legs

- Pregnant, breast feeding, or planning pregnancy prior to study end

- Serious mental health illness or psychiatric hospitalization in past 2 years

- Developmental disability or cognitive impairment that would impact study
participation

- Involved in litigation/receiving disability benefits related to the parameters of the
study

- Participation in research in the past 30 days