Edematous Fibrosclerotic PanniculopathyPhase 3NCT03526549
Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)
A Phase 3 study testing CCH-aaes and Observation in people with Edematous Fibrosclerotic Panniculopathy and Cellulite, run by Endo USA Inc., a Keenova Therapeutics Company at 42 sites in United States.
Trial summary
A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835 (Collagenase Clostridium Histolyticum [CCH]-aaes) lasts in the treatment of Cellulite. 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?
- CCH-aaes and Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 483 participants
- Where
- 42 sitesUnited States
- Study dates
- 26 Apr 2018to 8 Oct 2021
- Phase
- Phase 3
- 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
- All Participants (Through Day 180):
- Voluntarily sign and date an informed consent agreement
- Have participated in and completed the double-blind Phase 3 study EN3835-302 or EN3835-303
- Be willing to apply sunscreen to the buttocks before each exposure to the sun and/or tanning booths while participating in the study
- Be judged to be in good health
- Be willing and able to cooperate with the requirements of the study
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- Be able to read, complete and understand the participant reported outcomes rating instruments in English.
- Key Inclusion Criteria for Participants Eligible for Retreatment:
- 1. Have a negative pregnancy test and using a stable and effective contraception method.
Who cannot join
- All Participants (Through Day 180):
- Intends to or has used any of the local applications/therapies/injections/procedures that restricts study participation
- Intends to use tanning spray or tanning booths during this period
- Has received or intends to receive an investigational drug or treatment, other than the treatment received in study EN3835-302/303 during this period
- Any other condition(s) that, in the Investigator's opinion, might indicate the participant to be unsuitable for the study
- Additional Exclusion Criteria may apply Post Day 180:
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- 1. Has received any collagenase treatments at any time since completion of the double-blind study (EN3835-302 or EN3835-303).
- Key Exclusion Criteria for Participants Eligible for Retreatment:
- 1. Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation
- Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, skin laxity, flaccidity and/or skin sagging, active cutaneous alteration, tattoo/mole) that restricts study participation
- Requires anticoagulant or antiplatelet medication during the study
- Prior to and during the course of retreatment, is nursing or providing breast milk in any manner, intends to become pregnant during the study, or intends to use tanning spray or tanning booths during the study
- Has received an investigational drug or treatment, other than treatment in study EN3835-302/303, within 30 days before retreatment with study drug
- Has a known systemic allergy to collagenase or any other excipient of study drug
- Has received any collagenase treatments at any time since completion of the double-blind study
- Any other condition(s) that, in the Investigator's opinion, might indicate the participant to be unsuitable for retreatment
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Endo Clinical Trial Site #22
Austin, Texas, 78759
Endo Clinical Trial Site #6
Beaumont, Texas, 77701
Endo Clinical Trial Site #38
Boca Raton, Florida, 33486
Endo Clinical Trial Site #1
Charlottesville, Virginia, 22911
Endo Clinical Trial Site #34
Chicago, Illinois, 60654
Endo Clinical Trial Site #26
Cincinnati, Ohio, 45236
Endo Clinical Trial Site #8
Coral Gables, Florida, 33146
Endo Clinical Trial Site #14
Encinitas, California, 92024
Endo Clinical Trial Site #3
Glendale, Arizona, 85308
Endo Clinical Trial Site #23
Greenwood Village, Colorado, 80111
Endo Clinical Trial Site #13
Houston, Texas, 77056
Endo Clinical Trial Site #7
Houston, Texas, 77494
Endo Clinical Trial Site #30
Indianapolis, Indiana, 46260
Endo Clinical Trial Site #40
Largo, Florida, 33770
Endo Clinical Trial Site #9
Long Beach, California, 90806
Endo Clinical Trial Site #2
Lynchburg, Virginia, 24501
Endo Clinical Trial Site #19
Meridian, Idaho, 83642
Endo Clinical Trial Site #16
Metairie, Louisiana, 70006
Endo Clinical Trial Site #27
Miami, Florida, 33137
Endo Clinical Trial Site #36
Miami, Florida, 33185
Endo Clinical Trial Site #24
Mount Kisco, New York, 10549
Endo Clinical Trial Site #35
Murrieta, California, 92562
Endo Clinical Trial Site #5
Nashville, Tennessee, 37215
Endo Clinical Trial Site #10
New Orleans, Louisiana, 70115
Endo Clinical Trial Site #25
New Orleans, Louisiana, 70124
Endo Clinical Trial Site #32
New York, New York, 10016
Endo Clinical Trial Site #12
New York, New York, 10022
Endo Clinical Trial Site #15
New York, New York, 10065
Endo Clinical Trial Site #29
New York, New York, 10075
Endo Clinical Trial Site #42
Newport Beach, California, 92663
Endo Clinical Trial Site #41
North Little Rock, Arkansas, 72116
Endo Clinical Trial Site #17
Oceanside, California, 92056
Endo Clinical Trial Site #4
Omaha, Nebraska, 68144
Endo Clinical Trial Site #28
Pflugerville, Texas, 78660
Endo Clinical Trial Site #33
Quincy, Massachusetts, 02169
Endo Clinical Trial Site #31
Salt Lake City, Utah, 84101
Endo Clinical Trial Site #21
San Antonio, Texas, 78229
Endo Clinical Trial Site #39
San Diego, California, 92121
Endo Clinical Trial Site #11
Scottsdale, Arizona, 85258
Endo Clinical Trial Site #20
Snellville, Georgia, 30078
Endo Clinical Trial Site #37
Sugar Land, Texas, 77497
Endo Clinical Trial Site #18
Washington, Missouri, 63090
About this study
Official title: A Phase 3b, Open-Label, Long-Term Study to Evaluate the Safety and Temporal Pattern of Response of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835 (Collagenase Clostridium Histolyticum [CCH]-aaes) lasts in the treatment of Cellulite.
Read the detailed description
This study included participants who completed EN3835-302 (NCT03428750) or EN3835-303 (NCT03446781) double-blind parent studies. The first part of this study consisted of an observational period conducted in a blinded fashion and where no treatments were administered between Day 71 of the parent studies and Day 180 in this Open-label extension study. Once these participants were unblinded at Day 180, only participants who received active CCH-aaes in the parent studies remained in this study and those who received placebo in the parent studies were not eligible to continue in the Open-label study. Assessments made at the Day 71/(End of Study [EOS]) visit of the parent studies served as initial screening assessments for this study.
In the Open-label Phase of the study, all participants who qualified for, and opted for, retreatment were administered CCH-aaes at 3 treatment sessions at 21-day intervals.
- Conditions
- Edematous Fibrosclerotic Panniculopathy, Cellulite
- Being tested
- CCH-aaes, Observation
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCH-aaesBiological
Also called EN3835, QWO™
Administered to participants who qualified for, and opted for, retreatment.
ObservationOther
No treatment administered during 180 days of observation.
| Study group | Role | What they receive |
|---|---|---|
| CCH-aaes Treatment in Parent Studies (EN3835-302/303) | Experimental | Participants who received CCH-aaes treatment in EN3835-302/303 were followed for 180 days of observation with no treatment. Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and entered the Open-label Phase of the study. Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals. Receives: Biological: CCH-aaes; Other: Observation |
| Placebo Treatment in Parent Studies (EN3835-302/303) | Other | Participants who received placebo in the parent studies, were followed for 180 days of observation with no treatment. After Day 180, all participants who received placebo during the double-blind parent studies were discontinued. No treatment was administered. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any unfavorable or unintended change in body structure (signs), body function (symptoms), laboratory result, or worsening of a pre-existing condition associated temporally with the use of the study medication whether or not considered related to the study medication. TEAEs were defined as any AEs with a start date equal to or after the date of the first injection. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Up to Day 1080
Percentage of Participants Who Were Seropositive for Anti-Drug Antibodies (ADAs) After CCH-aaes Treatment
Serum samples were analyzed for ADAs. The percentage of participants who developed ADAs (seropositive results) during the Open-label Phase of the study are reported.
Measured: From Day 180 (Open-label Phase) up to Day 1080
Secondary outcomes (3)
Time to 2-Level Reduction of Response in Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS)
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Time to reduction of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in PR-PCSS and CR-PCSS to the time at which a 2-level composite worsening of response was observed for the first time.
Measured: From Day 180 (Open-label Observation Phase) up to Day 1080
Time to 1-Level Reduction of Response in CR-PCSS and PR-PCSS
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Time to reduction of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in CR-PCSS and PR-PCSS to the time at which 1-level composite worsening of response was observed for the first time.
Measured: From Day 180 (Open-label Observation Phase) up to Day 1080
Time to Complete Loss of Response in CR-PCSS and PR-PCSS
CR-PCSS and PR-PCSS assess improvement in cellulite severity using a 5-level scale ranging from "0" (None) to "4" (Severe). Complete loss of response is defined as both CR-PCSS and PR-PCSS ratings returned to the baseline severity of the double-blind study or worse for both the buttocks. Time to complete loss of response (days) was defined as the number of days from Screening assessment of composite improvement in cellulite severity in CR-PCSS and PR-PCSS to the time at which complete loss of response was observed for the first time.
Measured: From Day 180 (Open-label Observation Phase) up to Day 1080
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start26 Apr 2018
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Chajko, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526549
- Sponsor's protocol ID
- EN3835-304
- Status last verified
- Aug 2023
- First submitted
- 25 Apr 2018
- Last updated
- 8 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Open-Label, Long-Term Study to Evaluate the Safety and Temporal Pattern of Response of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
- ClinicalTrials.gov ID
- NCT03526549
- Acronym / sponsor ID
- EN3835-304
- Conditions
- Edematous Fibrosclerotic Panniculopathy, Cellulite
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Posted 8 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835 (Collagenase Clostridium Histolyticum [CCH]-aaes) lasts in the treatment of Cellulite.
Detailed description
This study included participants who completed EN3835-302 (NCT03428750) or EN3835-303 (NCT03446781) double-blind parent studies. The first part of this study consisted of an observational period conducted in a blinded fashion and where no treatments were administered between Day 71 of the parent studies and Day 180 in this Open-label extension study. Once these participants were unblinded at Day 180, only participants who received active CCH-aaes in the parent studies remained in this study and those who received placebo in the parent studies were not eligible to continue in the Open-label study. Assessments made at the Day 71/(End of Study [EOS]) visit of the parent studies served as initial screening assessments for this study.
In the Open-label Phase of the study, all participants who qualified for, and opted for, retreatment were administered CCH-aaes at 3 treatment sessions at 21-day intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCH-aaes Treatment in Parent Studies (EN3835-302/303) | Experimental | Biological: CCH-aaes, Other: ObservationParticipants who received CCH-aaes treatment in EN3835-302/303 were followed for 180 days of observation with no treatment. Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and entered the Open-label Phase of the study. Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals. |
| Placebo Treatment in Parent Studies (EN3835-302/303) | Other | Other: ObservationParticipants who received placebo in the parent studies, were followed for 180 days of observation with no treatment. After Day 180, all participants who received placebo during the double-blind parent studies were discontinued. No treatment was administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily sign and date an informed consent agreement
- Have participated in and completed the double-blind Phase 3 study EN3835-302 or EN3835-303
- Be willing to apply sunscreen to the buttocks before each exposure to the sun and/or tanning booths while participating in the study
- Be judged to be in good health
- Be willing and able to cooperate with the requirements of the study
Key exclusion criteria (16 listed)
- Intends to or has used any of the local applications/therapies/injections/procedures that restricts study participation
- Intends to use tanning spray or tanning booths during this period
- Has received or intends to receive an investigational drug or treatment, other than the treatment received in study EN3835-302/303 during this period
- Any other condition(s) that, in the Investigator's opinion, might indicate the participant to be unsuitable for the study
- 1. Has received any collagenase treatments at any time since completion of the double-blind study (EN3835-302 or EN3835-303).
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 |
|---|---|---|
| CCH-aaesAlso: EN3835, QWO™Administered to participants who qualified for, and opted for, retreatment. | Biological | CCH-aaes Treatment in Parent Studies (EN3835-302/303) |
| ObservationNo treatment administered during 180 days of observation. | Other | CCH-aaes Treatment in Parent Studies (EN3835-302/303), Placebo Treatment in Parent Studies (EN3835-302/303) |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 1080
An adverse event (AE) was any unfavorable or unintended change in body structure (signs), body function (symptoms), laboratory result, or worsening of a pre-existing condition associated temporally with the use of the study medication whether or not considered related to the study medication. TEAEs were defined as any AEs with a start date equal to or after the date of the first injection. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Percentage of Participants Who Were Seropositive for Anti-Drug Antibodies (ADAs) After CCH-aaes Treatment
Time frame: From Day 180 (Open-label Phase) up to Day 1080
Serum samples were analyzed for ADAs. The percentage of participants who developed ADAs (seropositive results) during the Open-label Phase of the study are reported.
3 secondary outcomes
Time to 2-Level Reduction of Response in Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS)
Time frame: From Day 180 (Open-label Observation Phase) up to Day 1080
Time to 1-Level Reduction of Response in CR-PCSS and PR-PCSS
Time frame: From Day 180 (Open-label Observation Phase) up to Day 1080
Time to Complete Loss of Response in CR-PCSS and PR-PCSS
Time frame: From Day 180 (Open-label Observation Phase) up to Day 1080
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Karen Chajko study director
Endo USA Inc., a Keenova Therapeutics Company
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CCH-aaes and Observation in people with Edematous Fibrosclerotic Panniculopathy and Cellulite, run by Endo USA Inc., a Keenova Therapeutics Company at 42 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 9 inclusion and 16 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 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Sep 2023). 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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to Day 1080). The study lists 2 primary outcomes in all. 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 8 Sep 2023.