Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 31, 2017
First Posted Date  ICMJE November 6, 2017
Results First Submitted Date  ICMJE August 5, 2020
Results First Posted Date  ICMJE November 23, 2020
Last Update Posted Date December 29, 2020
Actual Study Start Date  ICMJE November 17, 2017
Actual Primary Completion Date September 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
Effectiveness Variable - 2 levels [ Time Frame: Day 22, Day 43, Day 90, and Day 180 ]
Proportion of responders defined as subjects with an improvement in severity from baseline of at least 2 levels of severity in the CR-PCSS (Clinician-Reported Photonumeric Cellulite Severity Scale)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 7, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: October 31, 2017)
  • Effectiveness Variable - 1 level [ Time Frame: Day 22, Day 43, Day 90, and Day 180 ]
    Proportion of responders defined as subjects with an improvement in severity from baseline of at least 1 level of severity in the CR-PCSS (Clinician-Reported Photonumeric Cellulite Severity Scale)
  • Effectiveness Variable - Subject Satisfaction [ Time Frame: Day 180 ]
    Proportion of responses at each level of the subject satisfaction with cellulite treatment
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of EN3835 in the Treatment of EFP in Women
Official Title  ICMJE A Phase 2 Open-Label Study of EN3835 In The Treatment of Edematous Fibrosclerotic Panniculopathy
Brief Summary An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Edematous Fibrosclerotic Panniculopathy
  • Cellulite
Intervention  ICMJE Biological: Collagenase Clostridium Histolyticum
During 3 treatment visits 12 injections will be given per treatment area
Other Name: Xiaflex
Study Arms  ICMJE Experimental: EN3835 Active
EN3835 0.84mg (Collagenase Clostridium Histolyticum)
Intervention: Biological: Collagenase Clostridium Histolyticum
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2018)
158
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2017)
150
Actual Study Completion Date  ICMJE September 5, 2018
Actual Primary Completion Date September 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female birth gender
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03329989
Other Study ID Numbers  ICMJE EN3835-205
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Endo Pharmaceuticals
Study Sponsor  ICMJE Endo Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mike McLane, PhD Endo Pharmaceuticals
PRS Account Endo Pharmaceuticals
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP