Edematous Fibrosclerotic PanniculopathyPhase 1NCT03675685

Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP

A Phase 1 study testing CCH (collagenase clostridium histolyticum) in people with Edematous Fibrosclerotic Panniculopathy, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

This study will evaluate the safety and Pharmacokinetics (PK) of a single 3.36-mg dose of Collagenase Clostridium Histolyticum (CCH) in 4 quadrants concurrently, in subjects with Edematous fibrosclerotic panniculopathy (EFP). 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
What is being tested?: CCH (collagenase clostridium histolyticum)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 18 Sep 2018to 1 Nov 2018
Phase: Phase 1
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

No subject will be dosed until all eligibility criteria have been satisfied. In order to be eligible to participate in the study, subjects must meet the following criteria:
Be a female ≥18 years of age.
Have evidence of cellulite within 4 quadrants (a quadrant is defined as a left buttock, right buttock, left posterolateral thigh or right posterolateral thigh) as assessed by the Investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at the Screening visit; has a score of 2 (mild), 3 (moderate) or 4 (severe) as reported by the Investigator (CR-PCSS) in 4 quadrants at the Screening visit.
Have a body mass index (BMI) between 20.0 and 35.0 kg/m^2, and intends to maintain stable body weight throughout the duration of the study (a variation of ≤10% from baseline body weight is permitted).
Be willing to apply sunscreen to the dosing quadrants 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.

Show all 9Show fewer

Have a negative pregnancy test at the Screening visit and on Day -1 at admission (before injection of study drug); and be using an effective contraception method (e.g., abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or double barrier control) 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 (i.e., hysterectomy, bilateral oophorectomy, tubal ligation).
Be willing and able to cooperate with the requirements of the study.
Voluntarily sign and date an informed consent form approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC).

Who cannot join

A subject will be excluded from study participation if she:
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.

Show all 31Show fewer

Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values.
Has any of the following local conditions in the areas to be treated:
History of lower extremity thrombosis or post-thrombosis syndrome
Vascular disorder (e.g., varicose veins) in areas to be treated
Inflammation or active infection
Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer
Has a tattoo 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 a positive test on a urine drug screen for drugs of abuse
Has a history of drug or alcohol abuse
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 within the treatment quadrants during the 12-month period before injection of study drug
Injections (e.g., mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision) within the treatment quadrants during the 12-month period before injection of study drug
Endermologie or similar treatments within the treatment quadrants during the 6-month period before injection of study drug
Massage therapy within the treatment quadrants during the 3-month period before injection of study drug
Creams (e.g., Celluvera™, TriLastin®) to prevent or mitigate EFP within the treatment quadrants during the 2-week period before injection of study drug
Is presently nursing a baby or providing breast milk for a baby
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
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
Has been a subject in a previous cellulite clinical trial of CCH: AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, EN3835-202, EN3835-205, EN3835-302, EN3835-303, EN3835-304, and/or EN3835-209.

Trial locations and contacts

1 site in 1 country.

United States1 site

Endo Clinical Trial Site #1
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With Edematous Fibrosclerotic Panniculopathy

This study will provide insight to the PK profile and safety of concurrent subcutaneous injections of CCH 0.84 mg/quadrant into 4 quadrants.

Conditions: Edematous Fibrosclerotic Panniculopathy
Being tested: CCH (collagenase clostridium histolyticum)
Keywords: Cellulite, Edematous Fibrosclerotic Panniculopathy, EFP
Medical subject headings: Cellulite

What participants receive

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

CCH (collagenase clostridium histolyticum)Biological
A single dose of 3.36 mg of CCH will be administered as subcutaneous injections (CCH 0.84 mg) per quadrant concurrently in 4 quadrants. A quadrant is defined as one of the following: left buttock, right buttock, left posterolateral thigh, or right posterolateral thigh.

Study groups in NCT03675685
Study group	Role	What they receive
CCH (Collagenase clostridium histolyticum)	Experimental	Not described Receives: Biological: CCH (collagenase clostridium histolyticum)

What is being measured

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

Plasma AUX-I and AUX-II Concentrations
Determine if there is systemic exposure following a subcutaneous single dose of Collagenase clostridium histolyticum (CCH) (3.36 mg) as 12 injections per quadrant in 4 quadrants concurrently (0.84 mg per quadrant) in adult women with Edematous Fibrosclerotic Panniculopathy (EFP). There were no quantifiable levels of plasma AUX-I or AUX-II observed at any collection time point following subcutaneous injection of EN3835. As a result, no pharmacokinetic (PK) parameters were calculated.
Measured: Day 1 to Day 22
Investigator CR-PCSS Rating
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) scores for each quadrant are based on the investigator's CR-PCSS evaluation done at the Screening visit (Baseline) and at End of Study (Day 22). CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). Negative change reflects an improvement in cellulite severity; positive change reflects a worsening in cellulite severity.
Measured: Day 1 to Day 22
Investigator CR-PCSS Change From Baseline
Change from Baseline (Day 22 - Baseline). Baseline Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) scores for each quadrant are based on the investigator's CR-PCSS evaluation done at the Screening visit. CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). Negative change reflects an improvement in cellulite severity; positive change reflects a worsening in cellulite severity.
Measured: Day 1 to Day 22
Investigator CR-PCSS Responder Analysis at End of Study
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) scores for each quadrant are based on the investigator's CR-PCSS evaluation at the end of study. CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-point responder is a participant with a reduction of cellulite severity by at least 2 severity levels from baseline to end of study (i.e., change from baseline CR-PCSS rating of -2, -3, or -4). A 1-point responder is a participant with a reduction of cellulite severity by at least 1 severity level from baseline to end of study (i.e., change from baseline CR-PCSS rating of -1, -2, -3, or -4).
Measured: Day 22

Timeline

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

18 Sep 20181 Nov 2018

First posted18 Sep 2018
Study start18 Sep 2018
Primary completion1 Nov 2018
Study completion1 Nov 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03675685
Sponsor's protocol ID: EN3835-103
Status last verified: Sep 2020
First submitted: 15 Sep 2018
Last updated: 6 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
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 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With Edematous Fibrosclerotic Panniculopathy
ClinicalTrials.gov ID: NCT03675685
Acronym / sponsor ID: EN3835-103
Conditions: Edematous Fibrosclerotic Panniculopathy
Keywords: Cellulite, Edematous Fibrosclerotic Panniculopathy, EFP
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
Study start: 18 Sep 2018 (actual)
Primary completion: 1 Nov 2018 (actual)
Study completion: 1 Nov 2018 (actual)
First posted: 18 Sep 2018 (actual)
Results: Posted 6 Oct 2020

Clinical summary

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

This study will provide insight to the PK profile and safety of concurrent subcutaneous injections of CCH 0.84 mg/quadrant into 4 quadrants.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CCH (Collagenase clostridium histolyticum)	Experimental	Biological: CCH (collagenase clostridium histolyticum)

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

No subject will be dosed until all eligibility criteria have been satisfied. In order to be eligible to participate in the study, subjects must meet the following criteria:

Key exclusion criteria (31 listed)

A subject will be excluded from study participation if she:

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 (collagenase clostridium histolyticum)A single dose of 3.36 mg of CCH will be administered as subcutaneous injections (CCH 0.84 mg) per quadrant concurrently in 4 quadrants. A quadrant is defined as one of the following: left buttock, right buttock, left posterolateral thigh, or right posterolateral thigh.	Biological	CCH (Collagenase clostridium histolyticum)

Primary outcome

Plasma AUX-I and AUX-II Concentrations
Time frame: Day 1 to Day 22
Determine if there is systemic exposure following a subcutaneous single dose of Collagenase clostridium histolyticum (CCH) (3.36 mg) as 12 injections per quadrant in 4 quadrants concurrently (0.84 mg per quadrant) in adult women with Edematous Fibrosclerotic Panniculopathy (EFP). There were no quantifiable levels of plasma AUX-I or AUX-II observed at any collection time point following subcutaneous injection of EN3835. As a result, no pharmacokinetic (PK) parameters were calculated.
Investigator CR-PCSS Rating
Time frame: Day 1 to Day 22
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) scores for each quadrant are based on the investigator's CR-PCSS evaluation done at the Screening visit (Baseline) and at End of Study (Day 22). CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). Negative change reflects an improvement in cellulite severity; positive change reflects a worsening in cellulite severity.
Investigator CR-PCSS Change From Baseline
Time frame: Day 1 to Day 22
Change from Baseline (Day 22 - Baseline). Baseline Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) scores for each quadrant are based on the investigator's CR-PCSS evaluation done at the Screening visit. CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). Negative change reflects an improvement in cellulite severity; positive change reflects a worsening in cellulite severity.
Investigator CR-PCSS Responder Analysis at End of Study
Time frame: Day 22
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) scores for each quadrant are based on the investigator's CR-PCSS evaluation at the end of study. CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-point responder is a participant with a reduction of cellulite severity by at least 2 severity levels from baseline to end of study (i.e., change from baseline CR-PCSS rating of -2, -3, or -4). A 1-point responder is a participant with a reduction of cellulite severity by at least 1 severity level from baseline to end of study (i.e., change from baseline CR-PCSS rating of -1, -2, -3, or -4).

Results and safety

Results posted to the registry on 6 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CCH (Collagenase Clostridium Histolyticum)	12	12

Primary outcome: Plasma AUX-I and AUX-II Concentrations

Time frame: Day 1 to Day 22. Mean (Standard Deviation). Unit: mmol/L

Measure	CCH (Collagenase Clostridium Histolyticum) n = 12
Value	NA (NA)

Population analysed: Pharmacokinetic Population

Primary outcome: Investigator CR-PCSS Rating

Time frame: Day 1 to Day 22. Count of participants. Unit: Participants

Measure	Left Buttock n = 11	Right Buttock n = 11	Left Thigh n = 11	Right Thigh n = 11
Screening (Baseline): None (0)	0	0	0	0
Screening (Baseline): Almost None (1)	0	0	0	0
Screening (Baseline): Mild (2)	6	4	8	8
Screening (Baseline): Moderate (3)	4	6	3	3
Screening (Baseline): Severe (4)	1	1	0	0
Day 22 (End of Study): None (0)	0	0	0	0
Day 22 (End of Study): Almost None (1)	1	2	5	5
Day 22 (End of Study): Mild (2)	7	6	5	4

Population analysed: Cellulite Severity Population

Primary outcome: Investigator CR-PCSS Change From Baseline

Time frame: Day 1 to Day 22. Count of participants. Unit: Participants

Measure	Left Buttock n = 11	Right Buttock n = 11	Left Thigh n = 11	Right Thigh n = 11
-4	0	0	0	0
-3	0	0	0	0
-2	0	1	1	0
-1	5	4	5	7
0	5	5	5	3
+1	1	1	0	1
+2	0	0	0	0

Population analysed: Cellulite Severity Population

Primary outcome: Investigator CR-PCSS Responder Analysis at End of Study

Time frame: Day 22. Count of participants. Unit: Participants

Measure	Left Buttock n = 11	Right Buttock n = 11	Left Thigh n = 11	Right Thigh n = 11
2-point Responder: Yes	0	1	1	0
2-point Responder: No	11	10	10	11
1-point Responder: Yes	5	5	6	7
1-point Responder: No	6	6	5	4

Population analysed: Cellulite Severity Population

Adverse events

Time frame: All (serious and nonserious) AEs, from Day 1 up to Day 22. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CCH (Collagenase Clostridium Histolyticum)	0 of 12 (0%)	12 of 12 (100%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
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.

Saji Vijayan, MD study director

Endo USA Inc., a Keenova Therapeutics Company

1 site 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 9 inclusion and 31 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 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Oct 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?

Plasma AUX-I and AUX-II Concentrations (time frame: Day 1 to Day 22). The study lists 4 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 NCT03675685.

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 Oct 2020.