- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02724644
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
October 4, 2017 updated by: Endo Pharmaceuticals
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
375
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Beverly Hills, California, United States, 90210
- Clinical Testing of Beverly Hills
-
Murrieta, California, United States, 92562
- Dermatology Specialists, Inc
-
Oceanside, California, United States, 92056
- Dermatology Specialists, Inc
-
San Diego, California, United States, 92121
- Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc
-
-
Florida
-
Clearwater, Florida, United States, 33756
- Olympian Clinical Research
-
Coral Gables, Florida, United States, 33146
- Skin Research Institute LLC
-
West Palm Beach, Florida, United States, 33401
- Research Institute of the Southeast
-
-
Missouri
-
Washington, Missouri, United States, 10075
- Mercy Health Research
-
-
New York
-
New York, New York, United States, 10075
- Sadick Research Group
-
New York, New York, United States, 10065
- Bass Plastic Surgery, PLLC
-
-
North Carolina
-
High Point, North Carolina, United States, 27262
- Dermatology Consulting Services
-
-
Tennessee
-
Nashville, Tennessee, United States, 37215
- Tennessee Clinical Research Center
-
-
Texas
-
Pflugerville, Texas, United States, 78660
- Austin Institute for Clinical Research
-
-
Virginia
-
Charlottesville, Virginia, United States, 22911
- Charlottesville Medical Research Center LLC
-
Lynchburg, Virginia, United States, 24501
- The Education & Research Foundation
-
-
Washington
-
Spokane, Washington, United States, 99202
- Premier Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Injectable intervention
Other Names:
|
Placebo Comparator: EN3835 Placebo
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Day 71
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Day 71
|
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).
|
Baseline, Day 71
|
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).
|
Baseline, Day 71
|
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.
|
Baseline, Day 71
|
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).
|
Baseline, Day 71
|
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).
|
Baseline, Day 71
|
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.
|
Baseline, Day 71
|
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).
|
Day 71
|
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)
|
Day 71
|
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).
|
Day 71
|
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
|
Baseline, Day 71
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
March 10, 2016
First Submitted That Met QC Criteria
March 25, 2016
First Posted (Estimate)
March 31, 2016
Study Record Updates
Last Update Posted (Actual)
November 6, 2017
Last Update Submitted That Met QC Criteria
October 4, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EN3835-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cellulite
-
Endo PharmaceuticalsCompletedEdematous Fibrosclerotic Panniculopathy (Cellulite)United States
-
Galderma R&DCompletedCellulite of the ButtocksBrazil
-
DSM Nutritional Products, Inc.TerminatedCellulite (Orange Peel Skin)Brazil
-
Nutrasource Pharmaceutical and Nutraceutical Services...Completed
-
InMode MD Ltd.Completed
-
Syneron MedicalTerminatedCircumference Reduction | Cellulite ReductionUnited States
-
Cairo UniversityNot yet recruitingEfficacy of Treatment of Cellulite Using Carboxy Therapy
-
Cutera Inc.CompletedTreatment for Cellulite on the Stomach and FlanksUnited States
-
Endo PharmaceuticalsCompletedEdematous Fibrosclerotic Panniculopathy (Cellulite)United States
-
Zeltiq AestheticsActive, not recruiting
Clinical Trials on Placebo Comparator
-
Eisai Inc.CompletedAlzheimer's DiseaseUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Merck Sharp & Dohme LLCTerminated
-
Merck Sharp & Dohme LLCWithdrawn
-
Merck Sharp & Dohme LLCTerminated
-
TiumBio Co., Ltd.RecruitingEndometriosisCzechia, Italy, Russian Federation, Poland, Ukraine
-
Merck Sharp & Dohme LLCTerminatedType 2 Diabetes
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Cognition TherapeuticsRecruitingAge-Related Macular DegenerationUnited States