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

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.