EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

Inclusion Criteria

• Be a female ≥18 years of age
• At Screening visit, have at least 1 quadrant with:
• a score of 3 or 4 (moderate or severe) as reported by the subject (PR- PCSS), and
• a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and
• a Hexsel CSS score no greater than 13
• At Day 1 visit, have an assigned quadrant with:
• a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
• a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and
• a Hexsel CSS score no greater than 13
• Be willing to apply sunscreen to the selected treatment quadrant before each exposure to the sun while participating in the study (ie, screening through end of study).
• 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 be using an effective contraception method (eg, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or double barrier method) for at least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be menopausal defined as 12 months of amenorrhea in the absence of other biological or physiological causes, as determined by the investigator; or post-menopausal for at least 1 year; or be surgically sterile.
• Be willing and able to cooperate with the requirements of 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).
• Be able to read, complete and understand the Patient Reported Outcomes rating instruments in English

Exclusion Criteria

• Has any of the following conditions:
• Thyroid disease, unless controlled with medication for ≥6 months
• Uncontrolled diabetes mellitus, as determined by the Investigator
• Uncontrolled hypertension, as determined by the Investigator
• Vascular disorder (eg, phlebitis or varicose veins) in area to be treated
• Cushing's disease and/or use of systemic corticosteroids at a total daily dose greater than 5 mg prednisone (or equivalent)
• History of lower extremity thrombosis or post-thrombosis syndrome
• Documented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis
• Inflammation or active infection in area to be treated
• Active cutaneous alteration in area to be treated including rash, eczema, psoriasis or skin cancer
• History of keloidal scarring or abnormal wound healing
• Coagulation disorder
• Taking a medication for chronic anticoagulation (except for ≤150 mg aspirin daily)