Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as 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: NCT02724644
Recruitment Status : Completed
First Posted : March 31, 2016
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:
The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as Cellulite).

Condition or disease Intervention/treatment Phase
Edematous Fibrosclerotic Panniculopathy Cellulite Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM Biological: Placebo Comparator Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Study Start Date : February 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: EN3835 Active
EN3835 0.84 mg (Collagenase Clostridium Histolyticum). Each subject can receive up to three treatment sessions. Each treatment session will be separated by approximately 21 days.
Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Injectable intervention
Other Name: Xiaflex

Placebo Comparator: EN3835 Placebo
Placebo
Biological: Placebo Comparator



Primary Outcome Measures :
  1. Percentage of Composite Responders of at Least 2-Level Improvement of Severity [ Time Frame: Baseline, Day 71 ]
    Percentage of composite responders defined as subjects with an improvement from baseline of at least 2-levels of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement on each scale for example would represent a change from a 4 (severe) to a 2 (mild). In order to be considered a responder a subject needs to have at least a 2-level improvement on both scales.


Secondary Outcome Measures :
  1. Percentage of Composite Responders of at Least 1-Level Improvement of Severity [ Time Frame: Baseline, Day 71 ]
    Percentage of composite responders defined as subjects with improvement from baseline of at least 1-level of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement on each scale for example would represent a change from a 4 (severe) to a 3 (moderate). In order to be considered a responder a subject needs to have at least a 1-level improvement on both scales.

  2. CR-PCSS Responder Analysis: 2-Levels of Severity [ Time Frame: Baseline, Day 71 ]
    Percentage of subjects with improvement from baseline of at least 2-levels of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).

  3. CR-PCSS Responder Analysis: 1-Level of Severity [ Time Frame: Baseline, Day 71 ]
    Percentage of subjects with improvement from baseline of at least 1-level of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).

  4. CR-PCSS Change From Baseline [ Time Frame: Baseline, Day 71 ]
    The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.

  5. PR-PCSS Responder Analysis: 2-Levels of Severity [ Time Frame: Baseline, Day 71 ]
    Percentage of subjects with improvement from baseline of at least 2-levels of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).

  6. PR-PCSS Responder Analysis: 1-Level of Severity [ Time Frame: Baseline, Day 71 ]
    Percentage of subjects with improvement from baseline of at least 1-level of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).

  7. PR-PCSS Change From Baseline [ Time Frame: Baseline, Day 71 ]
    The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.

  8. Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) [ Time Frame: Day 71 ]
    On Day 71, the Investigator determined the degree of improvement from baseline in the treated area using the 7-point I-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3).

  9. Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) [ Time Frame: Day 71 ]
    At Day 71, subjects were asked to rate their opinion of the overall improvement of their treated area using the 7-point S-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3)

  10. Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale [ Time Frame: Day 71 ]
    At Day 71, subjects were asked to rate their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings could be satisfied (+1), very satisfied (+2), neither satisfied nor dissatisfied (0), or dissatisfied (-1), very dissatisfied (-2).

  11. Change in the Hexsel Cellulite Severity Scale (CSS) Total Score [ Time Frame: Baseline, Day 71 ]
    Investigator used the Hexsel CSS to assess the severity of cellulite. The total score could range from 0 (no cellulite) to 15 (extremely severe cellulite). Negative change in Hexsel CSS total score indicates an improvement in cellulite severity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be a female ≥18 years of age
  • At Screening visit, have at least 1 quadrant with:

    • a score of 3 or 4 (moderate or severe) as reported by the subject (PR- PCSS), and
    • a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and
    • a Hexsel CSS score no greater than 13
  • At Day 1 visit, have an assigned quadrant with:

    • a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
    • a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and
    • a Hexsel CSS score no greater than 13
  • Be willing to apply sunscreen to the selected treatment quadrant before each exposure to the sun while participating in the study (ie, screening through end of study).
  • Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening
  • Have a negative urine pregnancy test at screening and be using an 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.
  • Be willing and able to cooperate with the requirements of the study
  • Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC).
  • Be able to read, complete and understand the Patient Reported Outcomes rating instruments in English

Exclusion Criteria:

  • Has any of the following conditions:

    • Thyroid disease, unless controlled with medication for ≥6 months
    • Uncontrolled diabetes mellitus, as determined by the Investigator
    • Uncontrolled hypertension, as determined by the Investigator
    • Vascular disorder (eg, phlebitis or varicose veins) in area to be treated
    • Cushing's disease and/or use of systemic corticosteroids at a total daily dose greater than 5 mg prednisone (or equivalent)
    • History of lower extremity thrombosis or post-thrombosis syndrome
    • Documented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis
    • Inflammation or active infection in area to be treated
    • Active cutaneous alteration in area to be treated including rash, eczema, psoriasis or skin cancer
    • History of keloidal scarring or abnormal wound healing
    • Coagulation disorder
    • Taking a medication for chronic anticoagulation (except for ≤150 mg aspirin daily)

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): NCT02724644


Locations
Layout table for location information
United States, California
Clinical Testing of Beverly Hills
Beverly Hills, California, United States, 90210
Dermatology Specialists, Inc
Murrieta, California, United States, 92562
Dermatology Specialists, Inc
Oceanside, California, United States, 92056
Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc
San Diego, California, United States, 92121
United States, Florida
Olympian Clinical Research
Clearwater, Florida, United States, 33756
Skin Research Institute LLC
Coral Gables, Florida, United States, 33146
Research Institute of the Southeast
West Palm Beach, Florida, United States, 33401
United States, Missouri
Mercy Health Research
Washington, Missouri, United States, 10075
United States, New York
Bass Plastic Surgery, PLLC
New York, New York, United States, 10065
Sadick Research Group
New York, New York, United States, 10075
United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Austin Institute for Clinical Research
Pflugerville, Texas, United States, 78660
United States, Virginia
Charlottesville Medical Research Center LLC
Charlottesville, Virginia, United States, 22911
The Education & Research Foundation
Lynchburg, Virginia, United States, 24501
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Endo Pharmaceuticals

Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02724644     History of Changes
Other Study ID Numbers: EN3835-201
First Posted: March 31, 2016    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Cellulite
Edema
Skin Manifestations
Signs and Symptoms