Study of the Use of Low Level Laser Therapy to Reduce Acne

Acne is a chronic inflammatory disorder plaguing the sebaceous follicle, and debate still
remains over what truly initiates lesion formation. Experts agree that an increase in
androgen production plays a significant role in the onset of acne. Androgens promote the
increase in size of sebaceous glands and stimulate sebum production. The simple act of
sebaceous gland stimulation via androgens could ultimately promote the upregulation of
pro-inflammatory cytokines like tumor necrosis factor-α (TNF-α) and interleukin (IL-1α)
without propionibacteria even being present. The synthesis of IL-α and other
pro-inflammatory cytokines including prostaglandins occurs via the inducible enzyme known as
cyclooxygenase-2 (COX-2). Studies analyzing the pathogenesis of mucositis have identified
COX-2 as an important contributor to the upregulation of pro-inflammatory cytokines and thus
a major contributor to the progression of the disorder itself.

Recent evidence indicates that low-level laser therapy (LLLT) is able to significantly
diminish the expression of COX-2, resulting in the reduction of inflammation. The ability to
modulate the COX-2 pathways via LLLT is believed to inhibit the production of
pro-inflammatory cytokines (i.e. TNF-α and IL- α) present in acne-prone skin.

Inclusion Criteria:

- signed informed consent form.

- male or female.

- 18 to 40 years.

- area sought for acne reduction is the face.

- diagnosis of moderate or severe acne vulgaris, defined as grade 3-5 according to the
grading criteria of acne severity given by Burton et al.

- Acne has been ongoing for at least 3 months prior to screening and must include
inflammatory lesions.

- female using hormonal birth control must have been on a stable dose for at least 3
months prior to screening.

- negative pregnancy test for female subjects, unless the female subject has been
surgically sterilized.

- sexually active female subject who is not surgically sterile or 2 years post
menopausal must agree to use approved contraception/birth control measure while on
study

- PI (A normal healthy patient) or P2 (A patient with mild systemic disease) on the
American Society of Anesthesiologists (ASA) Physical Status Classification System.

- subject agrees to abstain from use of non-study treatments for acne while enrolled in
the study.

- subject agrees to abstain from use of tanning beds/sunbathing while partaking in the
study.

- subject agrees, and be able, to maintain regular medication schedule, as is medically
feasible, during study participation.

- subject agrees to not change skin care regimen throughout study participation.

- subject is willing and able to comply with all requirements of the study protocol.

Exclusion Criteria:

- use of topical acne treatment within 15 days prior to start of study.

- use of oral acne treatment within 30 days prior to the start of study.

- use of oral isotretinoin or other systemic retinoids in the 12 months preceding the
start of the study.

- use of systemic steroids within 30 days prior to the start of the study.

- pregnancy or currently nursing, or planning pregnancy during the course of the study

- participation in any clinical study involving an investigational product within 30
days of the start of the study

- use of tanning beds or sunbathing in the 30 days prior to the start of the study.

- history of keloids or other photosensitive disorders or use of any photosensitizing
medication.

- currently taking any medication that may alleviate or exacerbate acne.

- Porphyria or known allergies to porphyrins.

- current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic,
hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral
disease.

- known malignancy or history of malignancy other than non-melanoma skin cancer

- human immunodeficiency virus (HIV), hepatitis B or hepatitis C

- signs of bacterial, fungal or viral skin lesions that may interfere with assessment
of acne vulgaris.

- known inherited or acquired coagulation defects.

- substance abuse (drug or alcohol) problem within the previous 3 years.

- developmental disability or cognitive impairment that may preclude study compliance.

- unlikely to comply with the study protocol and procedure administration protocol, or
is considered unsuitable for participation in the study for any other reason in the
opinion of the investigator.