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History of Changes for Study: NCT03428750
Effectiveness and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women (RELEASE-1)
Latest version (submitted September 15, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 5, 2018 None (earliest Version on record)
2 February 16, 2018 Outcome Measures, Study Status and Study Identification
3 February 28, 2018 Outcome Measures and Study Status
4 March 16, 2018 Study Status and Contacts/Locations
5 April 11, 2018 Contacts/Locations and Study Status
6 May 21, 2018 Contacts/Locations and Study Status
7 June 7, 2018 Study Status and Contacts/Locations
8 July 9, 2018 Recruitment Status, Study Status and Contacts/Locations
9 October 2, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
10 September 26, 2019 Study Status
11 August 5, 2020
Quality Control Review has not concluded Returned: August 21, 2020
Outcome Measures, Study Status, Document Section, Adverse Events, Baseline Characteristics and Participant Flow
12 September 15, 2020 Study Status, Outcome Measures, Adverse Events and Baseline Characteristics
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Study NCT03428750
Submitted Date:  October 2, 2018 (v9)

Open or close this module Study Identification
Unique Protocol ID: EN3835-302
Brief Title: Effectiveness and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women (RELEASE-1)
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of EN3835 In The Treatment Of Edematous Fibrosclerotic Panniculopathy (Cellulite)
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2018
Overall Status: Completed
Study Start: February 5, 2018
Primary Completion: September 26, 2018 [Actual]
Study Completion: September 26, 2018 [Actual]
First Submitted: February 4, 2018
First Submitted that
Met QC Criteria:
February 5, 2018
First Posted: February 12, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
October 2, 2018
Last Update Posted: October 3, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Endo Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed, subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days 1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the buttocks will be at the discretion of the Investigator. End of study will occur at study day 71.
Detailed Description:
Open or close this module Conditions
Conditions: Edematous Fibrosclerotic Panniculopathy (Cellulite)
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 423 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: EN3835 Active
EN3835 0.84mg (Collagenase Clostridium Histolyticum)
Biological: EN3835
Collagenase clostridium histolyticum
Placebo Comparator: Placebo Biological: Placebo
Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Improvement in severity of target buttock from baseline of at least 2 levels of severity in Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)
[ Time Frame: 71 days ]

Scale is 5-levels, 0=None to 4=Severe
2. Improvement in severity of target buttock from baseline of at least 2 levels of severity in Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS)
[ Time Frame: 71 days ]

Scale is 5-levels, 0=None to 4=Severe
Secondary Outcome Measures:
1. Proportion of 1-level PR-PCSS responders defined as subjects with ≥1-level improvement in PR-PCSS severity rating of the target buttock
[ Time Frame: 71 Days ]

2. Proportion of 2-level PR-PCSS responders defined as subjects with ≥2-level improvement in PR-PCSS severity rating of target buttock
[ Time Frame: 71 Days ]

3. Proportion of 1-level composite responders of target buttock (subjects with improvement in severity from baseline of at least 1 level of severity in CR-PCSS and improvement of severity from baseline of at least 1 level of severity in the PR-PCSS)
[ Time Frame: 71 Days ]

4. Proportion of 2-level composite responders of the non-target buttock
[ Time Frame: 71 Days ]

5. Proportion of 1-level Subject Self Rating Scale responders defined as subjects who were at least slightly satisfied (Scale is 7 levels, 0=Extremely Dissatisfied to 6=Extremely Satisfied)
[ Time Frame: 71 Days ]

6. Change from baseline (Day 1) of the Patient Reported Cellulite Impact Scale total score (Scale 11 levels; 0=Not at All to 10=Extremely)
[ Time Frame: 71 Days ]

7. Proportion of 1-level Subject Global Aesthetic Improvement Scale (S-GAIS) responders defined as subjects with ≥1-level improvement (improved, much improved or very much improved) in S-GAIS assessment of the target buttock
[ Time Frame: 71 Days ]

8. Proportion of 2-level S-GAIS responders defined as subjects with ≥2-level improvement (much improved or very much improved) in the assessment of the target buttock
[ Time Frame: 71 Days ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: Yes
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 2 bilateral buttocks with each buttock having:
    1. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
    2. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS)
  4. At Day 1 visit, have 2 bilateral buttocks with each buttock having:
    1. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
    2. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS)
  5. Be willing to apply sunscreen to the buttocks before each exposure to the sun while participating in the study (ie, 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 (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
  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 areas to be treated:
    1. History of lower extremity thrombosis or post-thrombosis syndrome
    2. Vascular disorder (eg, varicose veins, telangiectasia) in area to be treated
    3. Inflammation or active infection
    4. Severe skin laxity, flaccidity, and/or sagging
    5. Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer
    6. 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 a 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 a buttock during the 12-month period before injection of study drug
    2. Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; buttock implant treatment; cryolipolysis; or surgery (including subcision and/or powered subcision) within a buttock during the 12-month period before injection of study drug
    3. Any investigational treatment for EFP on a buttock during the 12-month period before the injection of study drug
    4. Endermologie or similar treatments within a buttock during the 6-month period before injection of study drug
    5. Massage therapy within a buttock during the 3-month period before injection of study drug
    6. Creams (eg, Celluvera™, TriLastin®) and/or home therapies to prevent or mitigate EFP within a buttock 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 CCH: AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, EN3835-202, and/or EN3835-205
  14. Any other condition(s) that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study
Open or close this module Contacts/Locations
Study Officials: Michael McLane
Study Director
Endo Pharmaceuticals
Locations: United States, Arizona
Endo Clinical Trial Site #1
Scottsdale, Arizona, United States, 85258
United States, California
Endo Clinical Trial Site #2
Encinitas, California, United States, 92024
Endo Clinical Trial Site #3
Long Beach, California, United States, 90806
Endo Clinical Trial Site #4
Los Angeles, California, United States, 90025
Endo Clinical Trial Site #5
Oceanside, California, United States, 92056
Endo Clinical Trial Site #6
San Diego, California, United States, 92121
United States, Florida
Endo Clinical Trial Site #7
Boca Raton, Florida, United States, 33486
Endo Clinical Trial Site #8
Largo, Florida, United States, 33770
Endo Clinical Trial Site #9
Miami, Florida, United States, 33185
United States, Georgia
Endo Clinical Trial Site #10
Snellville, Georgia, United States, 30078
United States, Illinois
Endo Clinical Trial Site #11
Chicago, Illinois, United States, 60654
United States, Louisiana
Endo Clinical Trial Site #12
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Endo Clinical Trial Site #13
Chestnut Hill, Massachusetts, United States, 02467
Endo Clinical Trial Site #14
Quincy, Massachusetts, United States, 02169
United States, Minnesota
Endo Clinical Trial Site #15
Fridley, Minnesota, United States, 55432
United States, Missouri
Endo Clinical Trial Site #16
Washington, Missouri, United States, 63090
United States, Nebraska
Endo Clinical Trial Site #17
Omaha, Nebraska, United States, 68144
United States, New York
Endo Clinical Trial Site #18
Mount Kisco, New York, United States, 10549
Endo Clinical Trial Site #21
New York, New York, United States, 10022
Endo Clinical Trial Site #19
New York, New York, United States, 10065
Endo Clinical Trial Site #20
New York, New York, United States, 10075
United States, Ohio
Endo Clinical Trial Site #22
Cincinnati, Ohio, United States, 45249
United States, Texas
Endo Clinical Trial Site #23
Houston, Texas, United States, 77056
Endo Clinical Trial Site #24
Pflugerville, Texas, United States, 78660
Endo Clinical Trial Site #25
Sugar Land, Texas, United States, 77497
United States, Virginia
Endo Clinical Trial Site #26
Charlottesville, Virginia, United States, 22911
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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