Safety and Effectiveness of EN3835 in the Treatment of EFP in Women

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

Official Title
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A Phase 2 Open-Label Study of EN3835 In The Treatment of Edematous Fibrosclerotic Panniculopathy

Conditions
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Edematous Fibrosclerotic Panniculopathy, Cellulite

Intervention / Treatment
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* Biological: Collagenase Clostridium Histolyticum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily sign and date an informed consent agreement Be a female ≥18 years of age At Screening visit, have at least 2 bilateral quadrants with each quadrant having: a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and a Hexsel CSS score no greater than 13 At Day 1 visit, have assigned bilateral quadrants with each quadrant having: a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and a Hexsel CSS score no greater than 13 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) 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 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 Be willing and able to cooperate with the requirements of the study Be able to read, complete and understand the patient-reported outcomes rating instruments in English Exclusion Criteria: Has any of the following systemic conditions: Coagulation disorder Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years History of keloidal scarring or abnormal wound healing 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. Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values. Has any of the following local conditions in the area to be treated: History of lower extremity thrombosis or post-thrombosis syndrome Vascular disorder (e.g., varicose veins, telangiectasia) in area to be treated Inflammation or active infection Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer Has a tattoo and/or a mole located within 2 cm of the site of injection 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 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: Liposuction in the areas of the body selected for treatment during the 12-month period before injection of study drug 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 Endermologie or similar treatments within the assigned treatment quadrants during the 6 month period before injection of study drug Massage therapy within the assigned treatment quadrants during the 3-month period before injection of study drug Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the assigned treatment quadrants during the 2-week period before injection of study drug Is presently nursing or providing breast milk Intends to become pregnant during the study Intends to initiate an intensive sport or exercise program during the study Intends to initiate a weight reduction program during the study Intends to use tanning spray or tanning booths during the study Has received an investigational drug or treatment within 30 days before injection of study drug Has a known systemic allergy to collagenase or any other excipient of study drug Has received any collagenase treatments at any time prior to treatment 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 Any other condition(s) that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EN3835 Active<br>EN3835 0.84mg (Collagenase Clostridium Histolyticum) | Biological: Collagenase Clostridium Histolyticum<br>* During 3 treatment visits 12 injections will be given per treatment area<br>* Other names: Xiaflex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders | Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 2-levels of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from 0 (None) to 4 (Severe). A 2-level responder is a participant with a reduction in severity of at least 2-levels from Baseline at that particular visit. Number of participants analyzed is determined by observed participants at each visit. | Day 22, 43, 90, and 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders | Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 1-level of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from 0 (None) to 4 (Severe). A 1-level responder is a participant with a reduction in severity of at least 1-level from Baseline at that particular visit. Percentages are based on the observed counts. Number of participants analyzed is determined by observed participants at each visit. | Day 22, 43, 90, and 180 | 
| Subject Satisfaction With Cellulite Treatment Assessment at End of Study | At Day 180, participants rated their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings range from Very Satisfied with Treatment (2), Satisfied with Treatment (1), Neither Dissatisfied nor Satisfied with Treatment (0), Dissatisfied with Treatment (-1), and Very Dissatisfied with Treatment (-2). Percentages are based on the observed counts. | Day 180 |