Edematous Fibrosclerotic Panniculopathy (EFP)Phase 3NCT04170296

Real World CCH Study in Adult Females With Cellulite

A Phase 3 study testing EN3835 in people with Edematous Fibrosclerotic Panniculopathy (EFP) and Cellulite, run by Endo USA Inc., a Keenova Therapeutics Company at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP). Read more about this study

Who is it for?: Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Edematous Fibrosclerotic Panniculopathy (EFP), Cellulite
What is being tested?: EN3835
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 12 sitesin 2 countries
Study dates: 1 Nov 2019to 8 Jan 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 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Have both buttocks or both posterolateral thighs with:
A score of 2 or 3 (mild or moderate) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
A Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of 0 (absence of laxity, flaccidity, or sagging skin), or 1 (slightly draped appearance) at the Screening Visit only.
Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.
Be judged to be in good health.
Have a negative pregnancy test.
Be willing and able to cooperate with the requirements of the study.

Who cannot join

Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
Has systemic conditions (coagulation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.
Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2 (moderate draped appearance) or 3 (severe draped appearance).

Show all 12Show fewer

Requires anticoagulant or antiplatelet medication during the study.
Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
Has received any collagenase treatments at any time prior to treatment in this study and/or has received previous treatment with EN3835 or CCH for cellulite.
Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.
Is pregnant and/or is providing breast milk in any manner, or plans to become pregnant and/or to provide breast milk during the course of the study.
Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

United States11 sites

Endo Clinical Trial Site #10
Alpharetta, Georgia, 30005
Endo Clinical Trial Site #3
Chicago, Illinois, 60611
Endo Clinical Trial Site #1
Coral Gables, Florida, 33146
Endo Clinical Trial Site #2
Encino, California, 91436
Endo Clinical Trial Site #11
Itasca, Illinois, 60143
Endo Clinical Trial Site #12
Nashville, Tennessee, 37215
Endo Clinical Trial Site #8
New Orleans, Louisiana, 70130
Endo Clinical Trial Site #6
New York, New York, 10021
Endo Clinical Trial Site #4
San Diego, California, 92121
Endo Clinical Trial Site #5
Solana Beach, California, 92075
Endo Clinical Trial Site #9
Westport, Connecticut, 00688

Other trials in United States

Puerto Rico1 site

Endo Clinical Trial Site #7
San Juan, 00917

Other trials in Puerto Rico

About this study

Official title: A Real World, Multicenter, Open-Label, Multiple Dose Study to Assess the Effectiveness of, and Satisfaction With, CCH Treatment of Buttocks or Thigh Cellulite in Adult Females

This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP).

Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.

Conditions: Edematous Fibrosclerotic Panniculopathy (EFP), Cellulite
Being tested: EN3835
Medical subject headings: Cellulite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EN3835Drug
Collagenase Clostridium Histolyticum (CCH)

Study groups in NCT04170296
Study group	Role	What they receive
Cohort 1: Posterolateral Thigh	Experimental	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) Receives: Drug: EN3835
Cohort 2: Buttocks	Experimental	EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) Receives: Drug: EN3835

What is being measured

The primary outcome is the main question the study is designed to answer.

The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Measured: 90 Days
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Measured: 90 Days

Secondary outcomes (9)

Mean Change From Baseline in CR-PCSS for Each Buttock
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (none) to "4" (severe) from a clinician's perspective.
Measured: Day 22, 43, 90 and 180
Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score
The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
Measured: Day 90, Day 180
Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score
The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
Measured: Day 90, Day 180
The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Measured: Day 22, 43, and 180
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Measured: Day 22, 43, and 180
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Measured: Day 1, 90, and 180
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Measured: Day 1, 90 and 180
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Measured: Day 1, 90 and 180
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Measured: Day 1, 90 and 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20198 Jan 2021

First posted20 Nov 2019
Study start1 Nov 2019
Primary completion6 Oct 2020
Study completion8 Jan 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 Panniculopathy (EFP)Studies 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: Parallel groups
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04170296
Sponsor's protocol ID: EN3835-305
Status last verified: Jan 2022
First submitted: 18 Nov 2019
Last updated: 22 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Real World, Multicenter, Open-Label, Multiple Dose Study to Assess the Effectiveness of, and Satisfaction With, CCH Treatment of Buttocks or Thigh Cellulite in Adult Females
ClinicalTrials.gov ID: NCT04170296
Acronym / sponsor ID: EN3835-305
Conditions: Edematous Fibrosclerotic Panniculopathy (EFP), Cellulite
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
Study start: 1 Nov 2019 (actual)
Primary completion: 6 Oct 2020 (actual)
Study completion: 8 Jan 2021 (actual)
First posted: 20 Nov 2019 (actual)
Results: Posted 22 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP).

Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1: Posterolateral Thigh	Experimental	Drug: EN3835EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
Cohort 2: Buttocks	Experimental	Drug: EN3835EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Have both buttocks or both posterolateral thighs with:
Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.
Be judged to be in good health.
Have a negative pregnancy test.
Be willing and able to cooperate with the requirements of the study.

Key exclusion criteria (12 listed)

Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
Has systemic conditions (coagulation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.

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
EN3835Collagenase Clostridium Histolyticum (CCH)	Drug	Cohort 1: Posterolateral Thigh, Cohort 2: Buttocks

Primary outcome

The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
Time frame: 90 Days
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Time frame: 90 Days
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".

9 secondary outcomes

Mean Change From Baseline in CR-PCSS for Each Buttock
Time frame: Day 22, 43, 90 and 180
Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score
Time frame: Day 90, Day 180
Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score
Time frame: Day 90, Day 180
The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
Time frame: Day 22, 43, and 180
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Time frame: Day 22, 43, and 180
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
Time frame: Day 1, 90, and 180
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
Time frame: Day 1, 90 and 180
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
Time frame: Day 1, 90 and 180
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
Time frame: Day 1, 90 and 180

Results and safety

Results posted to the registry on 22 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Posterolateral Thigh	81	73
Cohort 2: Buttocks	72	68

Primary outcome: The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh

Time frame: 90 Days. Count of participants. Unit: Participants

Measure	Cohort 1: Posterolateral Thigh n = 63
Value	58

Population analysed: Evaluable Population includes all participants who have at least 1 injection of study medication and have at least 1 I-GAIS evaluation

Primary outcome: The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock

Time frame: 90 Days. Count of participants. Unit: Participants

Measure	Cohort 2: Buttocks n = 61
Value	58

Population analysed: Evaluable Population includes all participants who have at least 1 injection of study medication and have at least 1 I-GAIS evaluation

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Time of informed consent signature until Day 180. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Posterolateral Thigh	0 of 81 (0%)	75 of 81 (92.6%)	0 of 81
Cohort 2: Buttocks	0 of 72 (0%)	69 of 72 (95.8%)	0 of 72

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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.

David Hernandez study director

Endo USA Inc., a Keenova Therapeutics Company

12 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EN3835 in people with Edematous Fibrosclerotic Panniculopathy (EFP) and Cellulite, run by Endo USA Inc., a Keenova Therapeutics Company at 12 sites in 2 countries.

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 7 inclusion and 12 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 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Puerto Rico. 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 22 Feb 2022). 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?

The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh (time frame: 90 Days). 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?

On the ClinicalTrials.gov record for NCT04170296.

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 22 Feb 2022.