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

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ClinicalTrials.gov Identifier: NCT03329989
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : November 23, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Edematous Fibrosclerotic Panniculopathy Cellulite Biological: Collagenase Clostridium Histolyticum Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-Label Study of EN3835 In The Treatment of Edematous Fibrosclerotic Panniculopathy
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : September 5, 2018
Actual Study Completion Date : September 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EN3835 Active
EN3835 0.84mg (Collagenase Clostridium Histolyticum)
Biological: Collagenase Clostridium Histolyticum
During 3 treatment visits 12 injections will be given per treatment area
Other Name: Xiaflex




Primary Outcome Measures :
  1. Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders [ Time Frame: 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 :
  1. Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders [ Time Frame: 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.

  2. Subject Satisfaction With Cellulite Treatment Assessment at End of Study [ Time Frame: 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.


Other Outcome Measures:
  1. Overall Anti-AUX-I Serum Antibody by Visit [ Time Frame: Day 1 to Day 180 ]
    Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.

  2. Overall Anti-AUX-I Antibody Log Titer Levels by Visit [ Time Frame: Day 1 to Day 180 ]
    Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.

  3. Overall Anti-AUX-II Serum Antibody by Visit [ Time Frame: Day 1 to Day 180 ]
    Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.

  4. Overall Anti-AUX-II Antibody Log Titer Levels by Visit [ Time Frame: Day 1 to Day 180 ]
    Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.

  5. Anti-AUX-I Neutralizing Antibodies by Visit [ Time Frame: Day 1 to Day 180 ]
    A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the highest and lowest quartiles at Day 90 (Q1 and Q4) of seropositive participants at each of two visits (Day 90 and Day 180).

  6. Anti-AUX-II Neutralizing Antibodies by Visit [ Time Frame: Day 1 to Day 180 ]
    A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the study. Number of Participants Analyzed is determined by observed participants that had a seropositive sample at each visit and the antibody level at Day 71 in Q1 and Q4.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female birth gender
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329989


Locations
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United States, Arizona
Endo Clinical Trial Site #1
Scottsdale, Arizona, United States, 85258
United States, California
Endo Clinical Trial Site #2
Huntington Beach, California, United States, 92647
Endo Clinical Trial Site #3
San Diego, California, United States, 92121
Endo Clinical Trial Site #4
Santa Monica, California, United States, 90404
United States, Florida
Endo Clinical Trial Site #5
Coral Gables, Florida, United States, 33146
Endo Clinical Trial Site #6
Tampa, Florida, United States, 33626
Endo Clinical Trial Site #7
West Palm Beach, Florida, United States, 33401
United States, Georgia
Endo Clinical Trial Site #8
Alpharetta, Georgia, United States, 30022
United States, New York
Endo Clinical Trial Site #9
New York, New York, United States, 10003
United States, Tennessee
Endo Clinical Trial Site #10
Franklin, Tennessee, United States, 37067
United States, Texas
Endo Clinical Trial Site #11
Austin, Texas, United States, 78746
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Mike McLane, PhD Endo Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Endo Pharmaceuticals:
Study Protocol  [PDF] August 31, 2017
Statistical Analysis Plan  [PDF] August 30, 2018

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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03329989    
Other Study ID Numbers: EN3835-205
First Posted: November 6, 2017    Key Record Dates
Results First Posted: November 23, 2020
Last Update Posted: December 29, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cellulite
Edema
Skin Manifestations