The Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

Inclusion Criteria

• •Be a female and be ≥ 21 years of age and ≤ 60 years of age
• •Have a skin type classification of I through V according to the Fitzpatrick scale
• •Have EFP within the posterolateral thigh(s) and/or buttock(s) for at least 12 months before the screening visit
• •Have a photonumeric cellulite severity scale (CSS) score of ≥ 7 representing moderate to severe cellulite severity within the right or left buttock or the right or left posterolateral thigh (selected quadrant)
• •Have an area of EFP within the selected quadrant that is at least 8 cm x 10 cm (ie, target EFP area) and is suitable for treatment:
• •* The target EFP area must be located on the posterolateral thigh or within the buttock and does not involve the gluteal fold
• •* The target EFP area must be evident when the subject is standing, without the use of any manipulation such as skin pinching or muscle contraction (ie, CSS Classification E score of 2 or 3) at screening and before injection
• •Have a Body Mass Index (BMI) between 20.0 and 33.0 kg/m2, and intends to maintain stable body weight throughout the duration of the study (a variation of ≤5% from baseline body weight is permitted)
• •Be willing to refrain from using artificial tanning devices and lotions during the 2-week period before screening and throughout the duration of the study
• •Be willing to apply sunscreen with sun protection factor (SPF) ≥15 to the selected quadrant before each exposure to the sun while participating in the study (ie, screening through Day 90)
• •Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening
• •Have a negative urine pregnancy test at screening and before injection of AA4500 and be using an effective contraception method (ie, abstinence, intrauterine device \[IUD\], hormonal \[estrogen/progestin\] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study, or be surgically sterile, or be a postmenopausal female (no menses for at least 1 year or hysterectomy)
• •Be willing and able to cooperate with the requirements of the study including requirements during the confinement period and throughout the study
• •Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC). The subject must also sign an authorization form to allow disclosure of her protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution
• •Be able to complete and understand the various rating instruments in English