A Phase 2 interventional study of EN3835 in Cellulite and Edematous Fibrosclerotic Panniculopathy (EFP), sponsored by Endo Pharmaceuticals. Terminated at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-07.
Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Phase 2, Interventional, and Treatment
This is a single center, open-label, Phase 2a study to assess the photonumeric scale, morphological, and histopathological changes associated with Collagenase Clostridium Histolyticum (CCH) in adult women with moderate or severe Edematous Fibrosclerotic Panniculopathy (EFP).
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 7 is below the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →Endo Pharmaceuticals is the lead sponsor of 99 studies on the registry; none are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.
First submitted before Endo Pharmaceuticals became part of Keenova Therapeutics plc.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have both buttocks or both posterolateral thighs with:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
Drug: EN3835
Collagenase Clostridium Histolyticum (CCH)
The Change From Baseline (Screening) in PR-PCSS
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a patient's perspective
Time frame: Day 71
The Change From Baseline (Screening) in CR-PCSS
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
Time frame: Day 22, Day 43 and Day 71
The Change From Baseline (Screening) in Hexsel Cellulite Severity Scale (CSS)
Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite, each feature is evaluated on a 4-point scale from "0" (Low) to "3" (High)
Time frame: Day 22, Day 43 and Day 71
MRI Before and After CCH Treatment
Magnetic Resonance Imaging (MRI) of cellulite before and after CCH treatment
Time frame: Day 71
Histopathology Before and After CCH Treatment
Histopathology of biopsies defined by the observation of the biopsied specimen by a trained Pathologist
Time frame: Day 71
| Milestone | Buttock | Posterolateral Thigh |
|---|---|---|
| Started | 4 | 3 |
| Completed | 0 | 0 |
| Not completed | 4 | 3 |
| Withdrew: Terminated due to the major disruption in study visits and protocol assessments due to covid-19 | 4 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a patient's perspective
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite, each feature is evaluated on a 4-point scale from "0" (Low) to "3" (High)
No measurements were reported for this outcome.
Magnetic Resonance Imaging (MRI) of cellulite before and after CCH treatment
No measurements were reported for this outcome.
Histopathology of biopsies defined by the observation of the biopsied specimen by a trained Pathologist
No measurements were reported for this outcome.
Collected over All (Serious and Non-Serious AEs) from Day 1 to Day 265. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Buttock | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Posterolateral Thigh | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | Buttock | Posterolateral Thigh |
|---|---|---|
| Injection site bruisingGeneral disorders | 4/4 | 3/3 |
| Injection site painGeneral disorders | 4/4 | 3/3 |
| Injection site discolourationGeneral disorders | 2/4 | 0/3 |
| Injection site massGeneral disorders | 0/4 | 1/3 |
| Wound dehiscenceInjury, poisoning and procedural complications | 0/4 | 1/3 |
| Injection site swellingGeneral disorders | 1/4 | 0/3 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 1/4 | 0/3 |
| Age, Continuous(years) | Buttock | Posterolateral Thigh | Total |
|---|---|---|---|
| Mean | 46.5 ± 5.46 | 38.3 ± 1.96 | 43.0 ± 5.93 |
| Sex: Female, Male(Participants) | Buttock | Posterolateral Thigh | Total |
|---|---|---|---|
| Female | 4 | 3 | 7 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Buttock | Posterolateral Thigh | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 3 | 7 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Buttock | Posterolateral Thigh | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 3 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Skin Category (Fitzpatrick Scale)(Participants) | Buttock | Posterolateral Thigh | Total |
|---|---|---|---|
| I (Pale white) | 0 | 0 | 0 |
| II (Fair) | 0 | 0 | 0 |
| III (Darker white) | 1 | 1 | 2 |
| IV (Light brown) | 3 | 2 | 5 |
| V (Brown) | 0 | 0 | 0 |
| VI (Dark brown or black) | 0 | 0 | 0 |
| Weight(Kg) | Buttock | Posterolateral Thigh | Total |
|---|---|---|---|
| Mean | 74.67 ± 12.836 | 78.32 ± 1.836 | 76.24 ± 9.344 |
| Height(cm) | Buttock | Posterolateral Thigh | Total |
|---|---|---|---|
| Mean | 163.83 ± 9.390 | 163.41 ± 2.933 | 163.65 ± 6.856 |
| Body Mass Index(kg/m^2) | Buttock | Posterolateral Thigh | Total |
|---|---|---|---|
| Mean | 27.73 ± 1.744 | 29.50 ± 0.300 | 28.49 ± 1.566 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Microbial Collagenase