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

Phase 2

Completed

• Conditions: Edematous Fibrosclerotic Panniculopathy; Cellulite
• Interventions: Biological: Collagenase Clostridium Histolyticum

• Registration Number: NCT03329989
• Lead Sponsor: Endo Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Study Start: 2017-11-17
• Primary Completion: 2018-09-05
• Study Completion: 2018-09-05
• Disposition First Submitted: 2019-09-04
• Results First Submitted: 2020-08-05
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-30
• Disposition First Submitted QC: 2020-10-30
• Results First Posted: 2020-11-23
• Disposition First Posted: 2020-11-23
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EN3835 Active	Collagenase Clostridium Histolyticum	EN3835 0.84mg (Collagenase Clostridium Histolyticum)

Primary Outcome Measures

Name	Time	Method
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders	Day 22, 43, 90, and 180	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.

Secondary Outcome Measures

Name	Time	Method
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders	Day 22, 43, 90, and 180	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.
Subject Satisfaction With Cellulite Treatment Assessment at End of Study	Day 180	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.

Trial Locations

Locations (11)

Endo Clinical Trial Site #1; 🇺🇸 Scottsdale, Arizona, United States

Endo Clinical Trial Site #7; 🇺🇸 West Palm Beach, Florida, United States

Endo Clinical Trial Site #2; 🇺🇸 Huntington Beach, California, United States

Endo Clinical Trial Site #5; 🇺🇸 Coral Gables, Florida, United States

Endo Clinical Trial Site #4; 🇺🇸 Santa Monica, California, United States

Endo Clinical Trial Site #6; 🇺🇸 Tampa, Florida, United States

Endo Clinical Trial Site #8; 🇺🇸 Alpharetta, Georgia, United States

Endo Clinical Trial Site #9; 🇺🇸 New York, New York, United States

Endo Clinical Trial Site #10; 🇺🇸 Franklin, Tennessee, United States

Endo Clinical Trial Site #11; 🇺🇸 Austin, Texas, United States

Endo Clinical Trial Site #3; 🇺🇸 San Diego, California, United States