EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Condition: Edematous Fibrosclerotic Panniculopathy; Cellulite
MeSH terms: Cellulite; Edema
Intervention: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM; Placebo Comparator
Intervention description: Injectable intervention
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 375.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the
      treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as
      Cellulite).
    

Eligibility criteria:

        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)