Edematous Fibrosclerotic PanniculopathyPhase 2NCT04580303

CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques

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 3 sites in United States.

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 study is designed to investigate the safety and efficacy of collagenase clostridium histolyticum (CCH) for the treatment of mild to moderate edematous fibrosclerotic panniculopathy (cellulite) in participants with moderate to severe dermal laxity in the buttocks or thighs with comparison between two (2) different… Read more about this study

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Edematous Fibrosclerotic Panniculopathy, Cellulite, Laxity; Skin
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: 35 participants
Where: 3 sitesUnited States
Study dates: 1 Oct 2020to 24 Sep 2021
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 to 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Have a body mass index of 18 to <29.9 kilograms/square meters
Have either both buttocks or both posterolateral thighs with:
Score of 2 or 3 (mild or moderate cellulite) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS)
Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of 2 or 3 (moderate or severe) as determined by the investigator
Have a negative pregnancy test or be of non-childbearing potential
Be willing and able to cooperate with the requirements of the study
Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 180/Early Termination Visit).

Who cannot join

Has a history of hypersensitivity or allergy to collagenase or any other excipients of CCH.
During Screening has a CR-PCSS score of less than 2 or greater than 3 for the area to be treated (buttocks or thighs) and/or has a Hexsel CSS Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of less than 2 or greater than 3 (severe) for the areas to be treated (buttocks or thighs).
Has a coagulation disorder, which requires anticoagulant or antiplatelet medication during the study (except for ≤150 mg aspirin daily), or has taken anticoagulant or antiplatelet medication(s) within 14 days before injection of study treatment (except for ≤150 mg aspirin daily).
Is a prisoner, an individual with impaired decision making capacity, 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), or in the judgment of the investigator the participant is disadvantaged and vulnerable to coercion due to lack of education, or due to poor economic circumstances.
Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH in a previous investigational study for cellulite.
Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study.

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Has a history of scarring due to keloids or abnormal wound healing.
Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation
Has history of drug or alcohol abuse within the 5 years prior to the Screening Visit.
Has evidence of clinically significant abnormalities, as judged by the investigator, in any of the following: physical examination findings, electrocardiogram (ECG), clinical laboratory values, or vital signs.
The sponsor's medical monitor will be required to review the results for confirmation of eligibility in the case of any of the following: abnormalities in electrocardiograms indicating corrected QT interval (QTc) prolongation of 470 milliseconds or greater; and clinical laboratory values of liver enzymes
Has used or intends to use any of the local application/therapies/injections/procedures that restricts study participation.
Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
For the subset of participants participating in the collection of ultrasound data, the following exclusions will apply: participants will be excluded who have: a history of a spinal laminectomy, a previous history or presence of vascular abnormalities (for example, deep vein thrombosis, thrombophlebitis), a healing fracture, an impaired sensation within, or near, the planned treatment area, or any implants within, or near, the planned treatment area.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Endo Clinical Trial Site #3
Coral Gables, Florida, 33146
Endo Clinical Trial Site #2
Metairie, Louisiana, 70006
Endo Clinical Trial Site #1
New York, New York, 10021

Other trials in United States

About this study

Official title: A Phase 2 Multicenter, Open-label, Randomized, Parallel-group, Multiple-dose Study to Assess the Effectiveness, Safety and Satisfaction With Collagenase Clostridium Histolyticum Grid Technique Injections of Buttock or Thigh Cellulite With Laxity in Adult Females

Conditions: Edematous Fibrosclerotic Panniculopathy, Cellulite, Laxity; Skin
Being tested: collagenase clostridium histolyticum
Medical subject headings: Cellulite, Cutis Laxa

What participants receive

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

collagenase clostridium histolyticumDrug
Also called EN3835, CCH
Delivered via uniform grid injection techniques.

Study groups in NCT04580303
Study group	Role	What they receive
Uniform 0.1-milliliters (mL) 1-Aliquot Grid Injection Technique (Buttock)	Active comparator	Dose per participant per treatment visit = up to 1.68 milligrams (mg) of CCH (0.84 mg in each treatment area) Receives: Drug: collagenase clostridium histolyticum
Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock)	Active comparator	Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area) Receives: Drug: collagenase clostridium histolyticum
Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thigh)	Active comparator	Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area) Receives: Drug: collagenase clostridium histolyticum
Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thigh)	Active comparator	Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area) Receives: Drug: collagenase clostridium histolyticum

What is being measured

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

Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh
I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.
Measured: Day 180

Secondary outcomes (6)

Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh
I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.
Measured: Days 28, 56, 84, 112, and 140
Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh
S-GAIS assessments were based on digital photographs, and were performed separately for each of 2 treatment areas. S-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the participant ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level S-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the S-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.
Measured: Days 28, 56, 84, 112, 140, and 180
Change From Baseline in Body-Q Appraisal of Cellulite Total Score
The Body-Q Appraisal of Cellulite is a subset of 11 questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. Total score is the sum of all 11 question scores. The minimum possible total score is 11 and the maximum possible total score is 44. Higher scores indicate the individual is less bothered by their cellulite.
Measured: Baseline, Day 180
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score
Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale from a low of 0 to high of 3: 0 (absence of laxity, flaccidity, or sagging skin), 1 (slight draped appearance), 2 (moderate draped appearance), and 3 (severe draped appearance). The investigator or qualified designee used the Hexsel CSS Subsection D to assess the severity of dermal laxity in each buttock or each thigh independently. A decrease from baseline indicated a better outcome.
Measured: Baseline, Days 28, 56, 84, 112,140, and 180
Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies
Blood samples were collected to assess anti-clostridial class I collagenase (AUX-I) and anti-Clostridial class II collagenase (AUX-II) antibody levels. The percentage of participants who were positive for anti-AUX-I and anti-AUX-II antibodies are presented.
Measured: Day 180
Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II
Blood samples were collected to assess neutralizing antibodies to AUX-I and AUX-II. The percentage of participants who were positive for neutralizing antibodies to AUX-I and AUX-II are presented.
Measured: Day 180

Timeline

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

1 Oct 202024 Sep 2021

First posted8 Oct 2020
Study start1 Oct 2020
Primary completion30 Aug 2021
Study completion24 Sep 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04580303
Sponsor's protocol ID: EN3835-224
Status last verified: Aug 2022
First submitted: 2 Oct 2020
Last updated: 28 Sep 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 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Multicenter, Open-label, Randomized, Parallel-group, Multiple-dose Study to Assess the Effectiveness, Safety and Satisfaction With Collagenase Clostridium Histolyticum Grid Technique Injections of Buttock or Thigh Cellulite With Laxity in Adult Females
ClinicalTrials.gov ID: NCT04580303
Acronym / sponsor ID: EN3835-224
Conditions: Edematous Fibrosclerotic Panniculopathy, Cellulite, Laxity; Skin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
Study start: 1 Oct 2020 (actual)
Primary completion: 30 Aug 2021 (actual)
Study completion: 24 Sep 2021 (actual)
First posted: 8 Oct 2020 (actual)
Results: Posted 28 Sep 2022

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Uniform 0.1-milliliters (mL) 1-Aliquot Grid Injection Technique (Buttock)	Active comparator	Drug: collagenase clostridium histolyticumDose per participant per treatment visit = up to 1.68 milligrams (mg) of CCH (0.84 mg in each treatment area)
Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock)	Active comparator	Drug: collagenase clostridium histolyticumDose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area)
Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thigh)	Active comparator	Drug: collagenase clostridium histolyticumDose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area)
Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thigh)	Active comparator	Drug: collagenase clostridium histolyticumDose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area)

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Have a body mass index of 18 to <29.9 kilograms/square meters
Have either both buttocks or both posterolateral thighs with:
Have a negative pregnancy test or be of non-childbearing potential
Be willing and able to cooperate with the requirements of the study
Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 180/Early Termination Visit).

Key exclusion criteria (14 listed)

Has a history of hypersensitivity or allergy to collagenase or any other excipients of CCH.
During Screening has a CR-PCSS score of less than 2 or greater than 3 for the area to be treated (buttocks or thighs) and/or has a Hexsel CSS Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of less than 2 or greater than 3 (severe) for the areas to be treated (buttocks or thighs).
Has a coagulation disorder, which requires anticoagulant or antiplatelet medication during the study (except for ≤150 mg aspirin daily), or has taken anticoagulant or antiplatelet medication(s) within 14 days before injection of study treatment (except for ≤150 mg aspirin daily).
Is a prisoner, an individual with impaired decision making capacity, 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), or in the judgment of the investigator the participant is disadvantaged and vulnerable to coercion due to lack of education, or due to poor economic circumstances.
Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH in a previous investigational study for cellulite.

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: EN3835, CCHDelivered via uniform grid injection techniques.	Drug	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thigh), Uniform 0.1-milliliters (mL) 1-Aliquot Grid Injection Technique (Buttock), Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock), Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thigh)

Primary outcome

Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh
Time frame: Day 180
I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.

6 secondary outcomes

Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh
Time frame: Days 28, 56, 84, 112, and 140
Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh
Time frame: Days 28, 56, 84, 112, 140, and 180
Change From Baseline in Body-Q Appraisal of Cellulite Total Score
Time frame: Baseline, Day 180
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score
Time frame: Baseline, Days 28, 56, 84, 112,140, and 180
Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies
Time frame: Day 180
Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II
Time frame: Day 180

Results and safety

Results posted to the registry on 28 Sep 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
Uniform 0.1-mL (Milliliter) 1-Aliquot Grid Injection Technique (Buttocks)	7	7
Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks)	9	8
Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs)	9	8
Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs)	10	10

Primary outcome: Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh

Time frame: Day 180. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) n = 7	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) n = 8	Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) n = 8	Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) n = 10
Value	85.7 (42.13 to 99.64)	87.5 (47.35 to 99.68)	75.0 (34.91 to 96.81)	80.0 (44.39 to 97.48)

Population analysed: Modified Intent-to-Treat (mITT) Population: All enrolled participants who received at least 1 injection of CCH and who had at least 1 valid I-GAIS evaluation after the injection of CCH.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 (after dosing) through Day 180. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks or Thighs)	0 of 16 (0%)	16 of 16 (100%)	0 of 16
Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks or Thighs)	0 of 19 (0%)	19 of 19 (100%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 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

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 28 Sep 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?

Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh (time frame: Day 180). 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 NCT04580303.

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 28 Sep 2022.