Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs

Exclusion Criteria

• •Use of any of the following for the treatment of cellulite on either thigh or either buttock within the timelines identified below or intends to use any of the following at any time during the course of the study:
• •Liposuction during the 12-month period prior to study treatment.
• •Injections (eg, mesotherapy, dermal fillers, biostimulatory fillers, clostridium collagenase histolyticum); radiofrequency device treatments; laser treatment; buttock or thigh implant treatment; cryolipolysis; or surgery (including subcision and/or powered subcision) during the 24-month period before injection of study treatment.
• •Any investigational treatment for cellulite on a buttock or thigh during the 12-month period before the injection of study treatment.
• •Endermologie or similar treatments during the 6 month period before injection of study treatment.
• •Massage therapy during the 3-month period before injection of study treatment.
• •Creams (eg, Tretinoin, Celluvera™, TriLastin®) and/or home therapies to prevent or treat cellulite during the two week period before injection of study treatment.
• •Subjects with scarring in treatment areas.
• •Has any of the following local conditions in the areas to be treated (both buttocks or both thighs):
• •History of lower extremity thrombosis or post-thrombosis syndrome.
• •Vascular disorder (eg, varicose veins)
• •A subject with tattoos or permanent implants in the treatment areas.
• •A subject with history of or the presence of any skin condition/disease in the treatment area that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis).
• •Subject who spray tanned or used sunless tanner in the treatment area 4 weeks prior to study treatment.
• •A subject with an active bacterial, fungal, or viral infection in the treatment area.
• •A subject with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
• •Any history of bleeding or coagulation disorders.
• •History of lidocaine sensitivity deemed by the investigator to preclude patient from enrolling in the study.
• •A subject planning any other cosmetic procedure to the study treatment area during the study period, other than the treatment that will be performed by the investigator.
• •Presence of incompletely healed wound in treatment area.
• •Non-Ablative laser to the treatment area in the last 3 months.
• •A female subject who is pregnant, nursing an infant or planning a pregnancy during the study.
• •Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.