Safety and Effectiveness of EN3835 in the Treatment of EFP in Women
Condition: Edematous Fibrosclerotic Panniculopathy; Cellulite
MeSH terms: Cellulite; Edema
Intervention: Collagenase Clostridium Histolyticum
Intervention description: During 3 treatment visits 12 injections will be given per treatment area
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in
      adult women.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Voluntarily sign and date an informed consent agreement

          2. Be a female ≥18 years of age

          3. At Screening visit, have at least 2 bilateral quadrants with each quadrant having:

               1. a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and

               2. a Hexsel CSS score no greater than 13

          4. At Day 1 visit, have assigned bilateral quadrants with each quadrant having:

               1. a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and

               2. a Hexsel CSS score no greater than 13

          5. Be willing to apply sunscreen to the assigned treatment quadrants before each exposure
             to the sun while participating in the study (i.e., Screening through end of study)

          6. Be judged to be in good health, based upon the results of a medical history, physical
             examination, and laboratory profile at Screening

          7. Have a negative serum pregnancy test at Screening and a negative urine pregnancy test
             before injection of study drug and be using a stable and effective contraception
             method (e.g., 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

          8. Be willing and able to cooperate with the requirements of the study

          9. Be able to read, complete and understand the patient-reported outcomes rating
             instruments in English

        Exclusion Criteria:

          1. Has any of the following systemic conditions:

               1. Coagulation disorder

               2. Evidence or history of malignancy (other than excised basal-cell carcinoma)
                  unless there has been no recurrence in at least 5 years

               3. History of keloidal scarring or abnormal wound healing

               4. Concurrent diseases or conditions that might interfere with the conduct of the
                  study, confound the interpretation of the study results, or endanger the
                  subject's well-being. Any questions about concurrent diseases should be discussed
                  with the Medical Monitor.

               5. Evidence of clinically significant abnormalities on physical examination, vital
                  signs, electrocardiogram (ECG), or clinical laboratory values.

          2. Has any of the following local conditions in the area to be treated:

               1. History of lower extremity thrombosis or post-thrombosis syndrome

               2. Vascular disorder (e.g., varicose veins, telangiectasia) in area to be treated

               3. Inflammation or active infection

               4. Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer

               5. Has a tattoo and/or a mole located within 2 cm of the site of injection

          3. Requires the following concomitant medications before or during participation in the
             trial:

             a. Anticoagulant or antiplatelet medication or has received anticoagulant or
             antiplatelet medication (except for ≤150 mg aspirin daily) within 7 days before
             injection of study drug

          4. Has used any of the following for the treatment of EFP on the legs or buttock within
             the timelines identified below or intends to use any of the following at any time
             during the course of the study:

               1. Liposuction in the areas of the body selected for treatment during the 12-month
                  period before injection of study drug

               2. Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment;
                  buttock and/or thigh implant treatment, or surgery (including subcision and/or
                  powered subcision) within the assigned treatment quadrants during the 12-month
                  period before injection of study drug

               3. Endermologie or similar treatments within the assigned treatment quadrants during
                  the 6 month period before injection of study drug

               4. Massage therapy within the assigned treatment quadrants during the 3-month period
                  before injection of study drug

               5. Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the
                  assigned treatment quadrants during the 2-week period before injection of study
                  drug

          5. Is presently nursing or providing breast milk

          6. Intends to become pregnant during the study

          7. Intends to initiate an intensive sport or exercise program during the study

          8. Intends to initiate a weight reduction program during the study

          9. Intends to use tanning spray or tanning booths during the study

         10. Has received an investigational drug or treatment within 30 days before injection of
             study drug

         11. Has a known systemic allergy to collagenase or any other excipient of study drug

         12. Has received any collagenase treatments at any time prior to treatment

         13. Was a subject in a previous cellulite clinical trial of collagenase clostridium
             histolyticum (CCH) : AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201,
             and/or EN3835-202

         14. Any other condition(s) that, in the Investigator's opinion, might indicate the subject
             to be unsuitable for the study.