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Long-Term Study of EN3835 in Edematous Fibrosclerotic Panniculopathy (Cellulite)

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: NCT03526549
Recruitment Status : Completed
First Posted : May 16, 2018
Last Update Posted : December 14, 2021
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 25, 2018
First Posted Date  ICMJE May 16, 2018
Last Update Posted Date December 14, 2021
Actual Study Start Date  ICMJE April 26, 2018
Actual Primary Completion Date October 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2021)
Proportion of participants who lose their response as compared to Day 71 of EN3835-302/303 [ Time Frame: 36 months ]
Measured by proportion of participants that both the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) scores/ratings return to baseline of the double-blind studies (EN3835-302/303) or worse; both CR-PCSS and PR-PCSS worsened 2-levels compared to the score at Day 71 of the double-blind studies (EN3835-302/303); either CR-PCSS or PR-PCSS worsened 2-levels compared to the scores at Day 71 of the double-blind studies (EN3835-302/303); both CR-PCSS and PR-PCSS scores worsened by 1-level compared to the corresponding scores at Day 71 of the double-blind studies (EN3835-302/303)
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
Proportion of subjects who lose their response as compared to Day 71 of EN3835-302/303 [ Time Frame: 60 months ]
Measured by proportion of subjects that both the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) scores/ratings return to baseline of the double-blind studies (EN3835-302/303) or worse; both CR-PCSS and PR-PCSS worsened 2-levels compared to the score at Day 71 of the double-blind studies (EN3835-302/303); either CR-PCSS or PR-PCSS worsened 2-levels compared to the scores at Day 71 of the double-blind studies (EN3835-302/303); both CR-PCSS and PR-PCSS scores worsened by 1-level compared to the corresponding scores at Day 71 of the double-blind studies (EN3835-302/303)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2021)
  • Proportion of participants at each level of improvement in the PR-PCSS [ Time Frame: 36 months ]
    Scale is 5 levels, 0=None to 4=Severe
  • Proportion of participants at each level of improvement in the CR-PCSS [ Time Frame: 36 months ]
    Scale is 5 levels, 0=None to 4=Severe
  • Changes in the Patient Reported Cellulite Impact Scale (PR-CIS) from Baseline (Day 1) of EN3835-302/303 [ Time Frame: 36 months ]
    Scale is 11 levels; 0=Not at All to 10=Extremely
  • Proportion of participants at each level of improvement in the Subject Satisfaction with Cellulite Treatment Assessment (SSCTA) [ Time Frame: 36 months ]
    Scale is 5 levels; -2=Very dissatisfied to +2=Very satisfied
  • Proportion of participants at each level of improvement in the Subject Self-Rating Scale (SSRS) [ Time Frame: 36 months ]
    Scale is 7 levels; 0=Extremely dissatisfied to 6=Extremely satisfied
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Proportion of subjects at each level of improvement in the PR-PCSS [ Time Frame: 60 months ]
    Scale is 5 levels, 0=None to 4=Severe
  • Proportion of subjects at each level of improvement in the CR-PCSS [ Time Frame: 60 months ]
    Scale is 5 levels, 0=None to 4=Severe
  • Changes in the Patient Reported Cellulite Impact Scale (PR-CIS) from Baseline (Day 1) of EN3835-302/303 [ Time Frame: 60 months ]
    Scale is 11 levels; 0=Not at All to 10=Extremely
  • Proportion of subjects at each level of improvement in the Subject Satisfaction with cellulite treatment [ Time Frame: 60 months ]
    Scale is 5 levels; -2=Very dissatisfied to +2=Very satisfied
  • Proportion of subjects at each level of improvement in the subject self-rating scale [ Time Frame: 60 months ]
    Scale is 7 levels; 0=Extremely dissatisfied to 6=Extremely satisfied
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Study of EN3835 in Edematous Fibrosclerotic Panniculopathy (Cellulite)
Official Title  ICMJE A Phase 3b, Open-Label, Long-Term Study to Evaluate the Safety and Temporal Pattern of Response of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
Brief Summary A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835 lasts in the treatment of Cellulite.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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: EN3835
Collagenase Clostridium Histolyticum (CCH)
Other Name: Xiaflex
Study Arms  ICMJE Experimental: EN3835 Active
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
Intervention: Biological: EN3835
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: December 13, 2021)
483
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
840
Actual Study Completion Date  ICMJE October 8, 2021
Actual Primary Completion Date October 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

All Subjects (Through Day 180):

  1. Voluntarily sign and date an informed consent agreement
  2. Have participated in and completed the double-blind Phase 3 study EN3835-302 or EN3835-303
  3. Be willing to apply sunscreen to the buttocks before each exposure to the sun while participating in the study
  4. Be judged to be in good health
  5. Be willing and able to cooperate with the requirements of the study
  6. Be able to read, complete and understand the subject reported outcomes rating instruments in English.

In addition to inclusion Criteria for All Subjects Through Day 180, additional Inclusion Criteria are listed below:

Inclusion Criteria - Category I Subjects:

  1. Received active EN3835 in study EN3835-302 or EN3835-303
  2. Maximum composite response at Day 71 in either or both buttocks in double-blind study EN3835-302 or EN3835-303 was ONLY a 1-level improvement on CR-PCSS/PR-PCSS

Inclusion Criteria - Category II Subjects:

  1. Received active EN3835 in study EN3835-302 or EN3835-303
  2. Maximum composite response at Day 71 in either or both buttocks in double-blind study EN3835-302 or EN3835-303 was at least a 2-level composite improvement on CR-PCSS/PR-PCSS

Inclusion Criteria - Category III Subjects:

1. Received active EN3835 in study EN3835-302 or EN3835-303 but did not meet eligibility criteria for Category I or Category II status

Inclusion Criteria - Retreatment Subjects (Eligible Category I and Category II Subjects Whom opt to Receive Retreatment):

1. Have a negative serum pregnancy test

Exclusion Criteria

All Subjects (Through Day 180):

  1. Intends to or has used any of the local applications/therapies/injections/procedures that restricts study participation
  2. Intends to use tanning spray or tanning booths during this period
  3. Has received or intends to receive an investigational drug or treatment, other than the treatment received in study EN3835-302/303 during this period
  4. Any other condition(s) that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study

In addition to Exclusion Criteria for All Subjects Through Day 180, additional Exclusion Criteria also apply to Category I and Category II subjects:

Exclusion Criteria - Category I and Category II Subjects (Post Day 180):

1. Has received any collagenase treatments at any time since completion of the double-blind study (EN3835-302 or EN3835-303).

Exclusion Criteria for Subjects Whom opt for Observations Only (ie, no retreatment): None

Exclusion Criteria - Category II Subjects:

Exclusion criteria for Subjects Whom opt for Observation Only (ie, no retreatment): None

Exclusion Criteria - Category III Subjects: None

Exclusion Criteria - Retreatment Subjects (Eligible Category I and Category II Subjects Whom opt to Receive Retreatment):

  1. Has systemic conditions (coagulation disorders, malignancy, keloidal scar, adnormal wound healing) that restricts study participation
  2. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, skin laxity, flaccidity and/or skin sagging, active cutaneous alteration, tattoo/mole) that restricts study participation
  3. Requires anticoagulant or antiplatelet medication during the study
  4. Prior to and during the course of retreatment (Treatment Visit 1 through Treatment Visit 4), is nursing or providing breast milk in any manner
  5. Prior to and during the course of retreatment (Treatment Visit 1 through Treatment Visit 4), intends to become pregnant during the study
  6. Prior to and during the course of retreatment (Treatment Visit 1 through Treatment Visit 4), intends to use tanning spray or tanning booths during the study
  7. Has received an investigational drug or treatment, other than treatment in study EN3835-302/303, within 30 days before retreatment with study drug
  8. Has a known systemic allergy to collagenase or any other excipient of study drug
  9. Has received any collagenase treatments at any time since completion of the double-blind study
  10. Any other condition(s) that, in the Investigator's opinion, might indicate the subject to be unsuitable for Category II retreatment
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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 NCT03526549
Other Study ID Numbers  ICMJE EN3835-304
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 Not Provided
Current Responsible Party Endo Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Endo Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Karen Chajko Endo Pharmaceuticals
PRS Account Endo Pharmaceuticals
Verification Date April 2021

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