Safety and Efficacy of Deoxycholate Treatment of Small Fatty Deformities ( SFD)

• Patients with Grade I, II, or III cellulite (based on the Nurnberger \& Muller Scale) by physician assessment, affecting less than or equal to 10 cm2 surface area, and / or the presence of post surgical deformities associated with liposuction.
• Males and nonpregnant, nonlactating females 18 to 55 years of age, inclusive, on the day of randomization (Visit 1). Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before Visit 1 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study. Females of childbearing potential who are not sexually active need not practice contraception.
• Time and ability to complete the study and comply with instructions.
• Understanding of the study and contents of the informed consent.
• History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization.
• Expected to understand and agree to comply with the visit schedule and all protocol specified tests and procedures and agreement by the subject to refrain from making significant changes, in the judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.
• Agreement to forgo any treatment or behavior (e.g., unshaven body hair) during the subject's participation in the study that may affect the assessments of the zones of area.
• Medically able to undergo the administration of study material determined by clinical and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality.
• Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

• Patients who present with adipose tumors (lipoma)
• Human immunodeficiency virus (HIV)- or medication-related lipodystrophies
• Concurrent therapy that, in the investigator's opinion, would interfere with evaluation of the efficacy or safety of the medication.
• Active infection involving the fatty deformity zones.
• Pregnant women, nursing mothers, or women who are planning pregnancy during the study, or think they may be pregnant at the start of the study. Throughout the course of the study, women of childbearing potential must use reliable forms of contraception (e.g. abstinence, oral contraceptives for more than 12 consecutive weeks prior to enrollment, or spermicide and condoms).
• Current history of chronic drug or alcohol abuse.
• Clinically diagnosed anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that, in the opinion of the investigator, might interfere with the patient's participation in the study.
• History of any intervention to treat cellulite (e.g., liposuction, surgery, laser, or lipolytic agents).
• History of trauma associated with the cellulite areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
• Body mass index of >40.0 as determined on Visit 1.
• A result on coagulation tests (PT, PTT) obtained within 28 days before randomization that indicates the presence of any clinically significant bleeding disorder.
• Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent.
• Treatment with radio frequency or laser procedures in the cellulite zones within 12 months before randomization.
• History of sensitivity to any components of the study material
• History of sensitivity to topical or local anesthetics (e.g., lidocaine, benzocaine, procaine).
• Previous participation in a deoxycholate trial.
• Treatment with an investigational device or agent within 30 days before randomization.