Edematous Fibrosclerotic PanniculopathyPhase 2NCT02724644
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
A Phase 2 study testing COLLAGENASE CLOSTRIDIUM HISTOLYTICUM in people with Edematous Fibrosclerotic Panniculopathy and Cellulite, run by Endo USA Inc., a Keenova Therapeutics Company at 16 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Edematous Fibrosclerotic Panniculopathy, Cellulite
- What is being tested?
- COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 16 sitesUnited States
- Study dates
- Feb 2016to Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Clinical Testing of Beverly Hills
Beverly Hills, California, 90210
Charlottesville Medical Research Center LLC
Charlottesville, Virginia, 22911
Olympian Clinical Research
Clearwater, Florida, 33756
Skin Research Institute LLC
Coral Gables, Florida, 33146
Dermatology Consulting Services
High Point, North Carolina, 27262
The Education & Research Foundation
Lynchburg, Virginia, 24501
Dermatology Specialists, Inc
Murrieta, California, 92562
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Bass Plastic Surgery, PLLC
New York, New York, 10065
Sadick Research Group
New York, New York, 10075
Dermatology Specialists, Inc
Oceanside, California, 92056
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc
San Diego, California, 92121
Premier Clinical Research
Spokane, Washington, 99202
Mercy Health Research
Washington, Missouri, 10075
Research Institute of the Southeast
West Palm Beach, Florida, 33401
About this study
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).
- Conditions
- Edematous Fibrosclerotic Panniculopathy, Cellulite
- Being tested
- COLLAGENASE CLOSTRIDIUM HISTOLYTICUM, Placebo Comparator
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLLAGENASE CLOSTRIDIUM HISTOLYTICUMBiological
Also called Xiaflex
Injectable intervention
Placebo ComparatorBiological
| Study group | Role | What they receive |
|---|---|---|
| EN3835 Active | Experimental | 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. Receives: Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM |
| EN3835 Placebo | Placebo comparator | Placebo Receives: Biological: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 71
Secondary outcomes (11)
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.
Measured: Baseline, Day 71
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).
Measured: Baseline, Day 71
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).
Measured: Baseline, Day 71
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.
Measured: Baseline, Day 71
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).
Measured: Baseline, Day 71
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).
Measured: Baseline, Day 71
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.
Measured: Baseline, Day 71
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).
Measured: Day 71
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)
Measured: Day 71
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).
Measured: Day 71
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
Measured: Baseline, Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Edematous Fibrosclerotic PanniculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724644
- Sponsor's protocol ID
- EN3835-201
- Status last verified
- Oct 2017
- First submitted
- 10 Mar 2016
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
- ClinicalTrials.gov ID
- NCT02724644
- Acronym / sponsor ID
- EN3835-201
- Conditions
- Edematous Fibrosclerotic Panniculopathy, Cellulite
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EN3835 Active | Experimental | Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUMEN3835 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. |
| EN3835 Placebo | Placebo comparator | Biological: Placebo ComparatorPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Be a female ≥18 years of age
- At Screening visit, have at least 1 quadrant with:
- At Day 1 visit, have an assigned quadrant with:
- 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
Key exclusion criteria (13 listed)
- Has any of the following conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COLLAGENASE CLOSTRIDIUM HISTOLYTICUMAlso: XiaflexInjectable intervention | Biological | EN3835 Active |
| Placebo Comparator | Biological | EN3835 Placebo |
Primary outcome
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.
11 secondary outcomes
Percentage of Composite Responders of at Least 1-Level Improvement of Severity
Time frame: Baseline, Day 71
CR-PCSS Responder Analysis: 2-Levels of Severity
Time frame: Baseline, Day 71
CR-PCSS Responder Analysis: 1-Level of Severity
Time frame: Baseline, Day 71
CR-PCSS Change From Baseline
Time frame: Baseline, Day 71
PR-PCSS Responder Analysis: 2-Levels of Severity
Time frame: Baseline, Day 71
PR-PCSS Responder Analysis: 1-Level of Severity
Time frame: Baseline, Day 71
PR-PCSS Change From Baseline
Time frame: Baseline, Day 71
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
Time frame: Day 71
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
Time frame: Day 71
Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale
Time frame: Day 71
Change in the Hexsel Cellulite Severity Scale (CSS) Total Score
Time frame: Baseline, Day 71
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COLLAGENASE CLOSTRIDIUM HISTOLYTICUM in people with Edematous Fibrosclerotic Panniculopathy and Cellulite, run by Endo USA Inc., a Keenova Therapeutics Company at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Composite Responders of at Least 2-Level Improvement of Severity (time frame: Baseline, Day 71). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.