Back to resultsEN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Primary Purpose
Edematous Fibrosclerotic Panniculopathy, Cellulite
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Edematous Fibrosclerotic Panniculopathy
Eligibility 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)
Sites / Locations
- Clinical Testing of Beverly Hills
- Dermatology Specialists, Inc
- Dermatology Specialists, Inc
- Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc
- Olympian Clinical Research
- Skin Research Institute LLC
- Research Institute of the Southeast
- Mercy Health Research
- Bass Plastic Surgery, PLLC
- Sadick Research Group
- Dermatology Consulting Services
- Tennessee Clinical Research Center
- Austin Institute for Clinical Research
- Charlottesville Medical Research Center LLC
- The Education & Research Foundation
- Premier Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EN3835 Active
EN3835 Placebo
Arm Description
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.
Placebo
Outcomes
Primary Outcome Measures
Percentage of Composite Responders of at Least 2-Level Improvement of Severity
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
Percentage of Composite Responders of at Least 1-Level Improvement of Severity
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.
CR-PCSS Responder Analysis: 2-Levels of Severity
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).
CR-PCSS Responder Analysis: 1-Level of Severity
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).
CR-PCSS Change From Baseline
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.
PR-PCSS Responder Analysis: 2-Levels of Severity
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).
PR-PCSS Responder Analysis: 1-Level of Severity
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).
PR-PCSS Change From Baseline
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.
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
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).
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
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)
Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale
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).
Change in the Hexsel Cellulite Severity Scale (CSS) Total Score
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02724644
Brief Title
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Official Title
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endo Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edematous Fibrosclerotic Panniculopathy, Cellulite
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
375 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EN3835 Active
Arm Type
Experimental
Arm Description
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.
Arm Title
EN3835 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Other Intervention Name(s)
Xiaflex
Intervention Description
Injectable intervention
Intervention Type
Biological
Intervention Name(s)
Placebo Comparator
Primary Outcome Measure Information:
Title
Percentage of Composite Responders of at Least 2-Level Improvement of Severity
Description
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.
Time Frame
Baseline, Day 71
Secondary Outcome Measure Information:
Title
Percentage of Composite Responders of at Least 1-Level Improvement of Severity
Description
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.
Time Frame
Baseline, Day 71
Title
CR-PCSS Responder Analysis: 2-Levels of Severity
Description
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).
Time Frame
Baseline, Day 71
Title
CR-PCSS Responder Analysis: 1-Level of Severity
Description
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).
Time Frame
Baseline, Day 71
Title
CR-PCSS Change From Baseline
Description
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.
Time Frame
Baseline, Day 71
Title
PR-PCSS Responder Analysis: 2-Levels of Severity
Description
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).
Time Frame
Baseline, Day 71
Title
PR-PCSS Responder Analysis: 1-Level of Severity
Description
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).
Time Frame
Baseline, Day 71
Title
PR-PCSS Change From Baseline
Description
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.
Time Frame
Baseline, Day 71
Title
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
Description
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).
Time Frame
Day 71
Title
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
Description
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)
Time Frame
Day 71
Title
Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale
Description
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).
Time Frame
Day 71
Title
Change in the Hexsel Cellulite Severity Scale (CSS) Total Score
Description
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
Time Frame
Baseline, Day 71
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Clinical Testing of Beverly Hills
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Dermatology Specialists, Inc
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Dermatology Specialists, Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Olympian Clinical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Skin Research Institute LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Research Institute of the Southeast
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Mercy Health Research
City
Washington
State/Province
Missouri
ZIP/Postal Code
10075
Country
United States
Facility Name
Bass Plastic Surgery, PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Austin Institute for Clinical Research
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Charlottesville Medical Research Center LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
The Education & Research Foundation
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
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