Edematous Fibrosclerotic PanniculopathyPhase 2NCT03329989
Safety and Effectiveness of EN3835 in the Treatment of EFP in Women
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 11 sites in United States.
Trial summary
An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- 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?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 11 sitesUnited States
- Study dates
- 17 Nov 2017to 5 Sep 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign and date an informed consent agreement
- Be a female ≥18 years of age
- At Screening visit, have at least 2 bilateral quadrants with each quadrant having:
- a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and
- a Hexsel CSS score no greater than 13
- At Day 1 visit, have assigned bilateral quadrants with each quadrant having:
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- a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and
- a Hexsel CSS score no greater than 13
- Be willing to apply sunscreen to the assigned treatment quadrants before each exposure to the sun while participating in the study (i.e., 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 serum pregnancy test at Screening and a negative urine pregnancy test before injection of study drug and be using a stable and effective contraception method (e.g., 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
- Be able to read, complete and understand the patient-reported outcomes rating instruments in English
Who cannot join
- Has any of the following systemic conditions:
- Coagulation disorder
- Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years
- History of keloidal scarring or abnormal wound healing
- Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. Any questions about concurrent diseases should be discussed with the Medical Monitor.
- Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values.
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- Has any of the following local conditions in the area to be treated:
- History of lower extremity thrombosis or post-thrombosis syndrome
- Vascular disorder (e.g., varicose veins, telangiectasia) in area to be treated
- Inflammation or active infection
- Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer
- Has a tattoo and/or a mole located within 2 cm of the site of injection
- Requires the following concomitant medications before or during participation in the trial:
- Anticoagulant or antiplatelet medication or has received anticoagulant or antiplatelet medication (except for ≤150 mg aspirin daily) within 7 days before injection of study drug
- Has used any of the following for the treatment of EFP on the legs or buttock within the timelines identified below or intends to use any of the following at any time during the course of the study:
- Liposuction in the areas of the body selected for treatment during the 12-month period before injection of study drug
- Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; buttock and/or thigh implant treatment, or surgery (including subcision and/or powered subcision) within the assigned treatment quadrants during the 12-month period before injection of study drug
- Endermologie or similar treatments within the assigned treatment quadrants during the 6 month period before injection of study drug
- Massage therapy within the assigned treatment quadrants during the 3-month period before injection of study drug
- Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the assigned treatment quadrants during the 2-week period before injection of study drug
- Is presently nursing or providing breast milk
- Intends to become pregnant during the study
- Intends to initiate an intensive sport or exercise program during the study
- Intends to initiate a weight reduction program during the study
- Intends to use tanning spray or tanning booths during the study
- Has received an investigational drug or treatment within 30 days before injection of study drug
- Has a known systemic allergy to collagenase or any other excipient of study drug
- Has received any collagenase treatments at any time prior to treatment
- Was a subject in a previous cellulite clinical trial of collagenase clostridium histolyticum (CCH) : AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, and/or EN3835-202
- Any other condition(s) that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Endo Clinical Trial Site #8
Alpharetta, Georgia, 30022
Endo Clinical Trial Site #11
Austin, Texas, 78746
Endo Clinical Trial Site #5
Coral Gables, Florida, 33146
Endo Clinical Trial Site #10
Franklin, Tennessee, 37067
Endo Clinical Trial Site #2
Huntington Beach, California, 92647
Endo Clinical Trial Site #9
New York, New York, 10003
Endo Clinical Trial Site #3
San Diego, California, 92121
Endo Clinical Trial Site #4
Santa Monica, California, 90404
Endo Clinical Trial Site #1
Scottsdale, Arizona, 85258
Endo Clinical Trial Site #6
Tampa, Florida, 33626
Endo Clinical Trial Site #7
West Palm Beach, Florida, 33401
About this study
Official title: A Phase 2 Open-Label Study of EN3835 In The Treatment of Edematous Fibrosclerotic Panniculopathy
An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.
- Conditions
- Edematous Fibrosclerotic Panniculopathy, Cellulite
- Being tested
- Collagenase Clostridium Histolyticum
- 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
During 3 treatment visits 12 injections will be given per treatment area
| Study group | Role | What they receive |
|---|---|---|
| EN3835 Active | Experimental | EN3835 0.84mg (Collagenase Clostridium Histolyticum) Receives: Biological: Collagenase Clostridium Histolyticum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 2-levels of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 2-level responder is a participant with a reduction in severity of at least 2-levels from Baseline at that particular visit. Number of participants analyzed is determined by observed participants at each visit.
Measured: Day 22, 43, 90, and 180
Secondary outcomes (2)
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 1-level of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 1-level responder is a participant with a reduction in severity of at least 1-level from Baseline at that particular visit. Percentages are based on the observed counts. Number of participants analyzed is determined by observed participants at each visit.
Measured: Day 22, 43, 90, and 180
Subject Satisfaction With Cellulite Treatment Assessment at End of Study
At Day 180, participants rated their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings range from Very Satisfied with Treatment (2), Satisfied with Treatment (1), Neither Dissatisfied nor Satisfied with Treatment (0), Dissatisfied with Treatment (-1), and Very Dissatisfied with Treatment (-2). Percentages are based on the observed counts.
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start17 Nov 2017
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike McLane, PhD, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329989
- Sponsor's protocol ID
- EN3835-205
- Status last verified
- Oct 2020
- First submitted
- 31 Oct 2017
- Last updated
- 29 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label Study of EN3835 In The Treatment of Edematous Fibrosclerotic Panniculopathy
- ClinicalTrials.gov ID
- NCT03329989
- Acronym / sponsor ID
- EN3835-205
- Conditions
- Edematous Fibrosclerotic Panniculopathy, Cellulite
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 23 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EN3835 Active | Experimental | Biological: Collagenase Clostridium HistolyticumEN3835 0.84mg (Collagenase Clostridium Histolyticum) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily sign and date an informed consent agreement
- Be a female ≥18 years of age
- At Screening visit, have at least 2 bilateral quadrants with each quadrant having:
- At Day 1 visit, have assigned bilateral quadrants with each quadrant having:
- Be willing to apply sunscreen to the assigned treatment quadrants before each exposure to the sun while participating in the study (i.e., Screening through end of study)
Key exclusion criteria (30 listed)
- Has any of the following systemic conditions:
- Has any of the following local conditions in the area to be treated:
- Requires the following concomitant medications before or during participation in the trial:
- Has used any of the following for the treatment of EFP on the legs or buttock within the timelines identified below or intends to use any of the following at any time during the course of the study:
- Is presently nursing or providing breast milk
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: XiaflexDuring 3 treatment visits 12 injections will be given per treatment area | Biological | EN3835 Active |
Primary outcome
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
Time frame: Day 22, 43, 90, and 180
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 2-levels of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 2-level responder is a participant with a reduction in severity of at least 2-levels from Baseline at that particular visit. Number of participants analyzed is determined by observed participants at each visit.
2 secondary outcomes
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
Time frame: Day 22, 43, 90, and 180
Subject Satisfaction With Cellulite Treatment Assessment at End of Study
Time frame: Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Mike McLane, PhD study director
Endo USA Inc., a Keenova Therapeutics Company
11 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 11 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 13 inclusion and 30 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 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. 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 23 Nov 2020). 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?
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders (time frame: Day 22, 43, 90, and 180). 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 29 Dec 2020.