A Phase 2 interventional study of Collagenase Clostridium Histolyticum in Edematous Fibrosclerotic Panniculopathy and Cellulite, sponsored by Endo Pharmaceuticals. Completed at 11 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-29.
Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Phase 2, Interventional, and Treatment
An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 158 is above 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.
At Screening visit, have at least 2 bilateral quadrants with each quadrant having:
At Day 1 visit, have assigned bilateral quadrants with each quadrant having:
Exclusion Criteria:
Has any of the following systemic conditions:
Has any of the following local conditions in the area to be treated:
Requires the following concomitant medications before or during participation in the trial:
a. 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 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:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
EN3835 0.84mg (Collagenase Clostridium Histolyticum)
Biological: Collagenase Clostridium Histolyticum
During 3 treatment visits 12 injections will be given per treatment area
Also known as: Xiaflex
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 2-levels of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 2-level responder is a participant with a reduction in severity of at least 2-levels from Baseline at that particular visit. Number of participants analyzed is determined by observed participants at each visit.
Time frame: Day 22, 43, 90, and 180
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 1-level of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 1-level responder is a participant with a reduction in severity of at least 1-level from Baseline at that particular visit. Percentages are based on the observed counts. Number of participants analyzed is determined by observed participants at each visit.
Time frame: Day 22, 43, 90, and 180
Subject Satisfaction With Cellulite Treatment Assessment at End of Study
At Day 180, participants rated their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings range from Very Satisfied with Treatment (2), Satisfied with Treatment (1), Neither Dissatisfied nor Satisfied with Treatment (0), Dissatisfied with Treatment (-1), and Very Dissatisfied with Treatment (-2). Percentages are based on the observed counts.
Time frame: Day 180
Overall Anti-AUX-I Serum Antibody by Visit
Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Time frame: Day 1 to Day 180
Overall Anti-AUX-I Antibody Log Titer Levels by Visit
Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Time frame: Day 1 to Day 180
Overall Anti-AUX-II Serum Antibody by Visit
Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Time frame: Day 1 to Day 180
Overall Anti-AUX-II Antibody Log Titer Levels by Visit
Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Time frame: Day 1 to Day 180
Anti-AUX-I Neutralizing Antibodies by Visit
A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the highest and lowest quartiles at Day 90 (Q1 and Q4) of seropositive participants at each of two visits (Day 90 and Day 180).
Time frame: Day 1 to Day 180
Anti-AUX-II Neutralizing Antibodies by Visit
A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the study. Number of Participants Analyzed is determined by observed participants that had a seropositive sample at each visit and the antibody level at Day 71 in Q1 and Q4.
Time frame: Day 1 to Day 180
| Milestone | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Started | 158 |
| Completed | 135 |
| Not completed | 23 |
| Withdrew: Withdrawal by subject | 9 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Adverse event | 5 |
| Withdrew: Protocol violation | 1 |
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 2-levels of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 2-level responder is a participant with a reduction in severity of at least 2-levels from Baseline at that particular visit. Number of participants analyzed is determined by observed participants at each visit.
| Participants | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| At Least One of two areas (Left & Right): Day 22 — Yes | 6 |
| At Least One of two areas (Left & Right): Day 22 — No | 131 |
| At Least One of two areas (Left & Right): Day 43 — Yes | 8 |
| At Least One of two areas (Left & Right): Day 43 — No | 125 |
| At Least One of two areas (Left & Right): Day 90 — Yes | 17 |
| At Least One of two areas (Left & Right): Day 90 — No | 110 |
| At Least One of two areas (Left & Right): Day 180 — Yes | 20 |
| At Least One of two areas (Left & Right): Day 180 — No | 111 |
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 1-level of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 1-level responder is a participant with a reduction in severity of at least 1-level from Baseline at that particular visit. Percentages are based on the observed counts. Number of participants analyzed is determined by observed participants at each visit.
| Participants | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| At Least One of Two Areas (Left & Right): Day 22 — Yes | 55 |
| At Least One of Two Areas (Left & Right): Day 22 — No | 82 |
| At Least One of Two Areas (Left & Right): Day 43 — Yes | 87 |
| At Least One of Two Areas (Left & Right): Day 43 — No | 46 |
| At Least One of Two Areas (Left & Right): Day 90 — Yes | 96 |
| At Least One of Two Areas (Left & Right): Day 90 — No | 31 |
| At Least One of Two Areas (Left & Right): Day 180 — Yes | 90 |
| At Least One of Two Areas (Left & Right): Day 180 — No | 41 |
At Day 180, participants rated their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings range from Very Satisfied with Treatment (2), Satisfied with Treatment (1), Neither Dissatisfied nor Satisfied with Treatment (0), Dissatisfied with Treatment (-1), and Very Dissatisfied with Treatment (-2). Percentages are based on the observed counts.
| Participants | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Very Satisfied with Treatment (2) | 25 |
| Satisfied with Treatment (1) | 48 |
| Neither Dissatisfied nor Satisfied with Treatment | 32 |
| Dissatisfied with Treatment (-1) | 12 |
| Very Dissatisfied with Treatment (-2) | 13 |
Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
| Participants | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Anti-AUX-I: Day 1 — Seropositive | 4 |
| Anti-AUX-I: Day 1 — Seronegative | 152 |
| Anti-AUX-I: Day 22 — Seropositive | 104 |
| Anti-AUX-I: Day 22 — Seronegative | 43 |
| Anti-AUX-I: Day 43 — Seropositive | 141 |
| Anti-AUX-I: Day 43 — Seronegative | 2 |
| Anti-AUX-I: Day 90 — Seropositive | 134 |
| Anti-AUX-I: Day 90 — Seronegative | 0 |
| Anti-AUX-I: Day 180 — Seropositive | 134 |
| Anti-AUX-I: Day 180 — Seronegative | 1 |
Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
| log 10 titer | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Anti-AUX-I: Day 1 positive | 2.046 ± 1.012 |
| Anti-AUX-I: Day 22 positive | 2.268 ± 1.076 |
| Anti-AUX-I: Day 43 positive | 4.681 ± 0.924 |
| Anti-AUX-I: Day 90 positive | 5.937 ± 0.686 |
| Anti-AUX-I: Day 180 positive | 5.556 ± 0.981 |
Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
| Participants | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Anti-AUX-I: Day 1 — Seropositive | 6 |
| Anti-AUX-I: Day 1 — Seronegative | 150 |
| Anti-AUX-I: Day 22 — Seropositive | 50 |
| Anti-AUX-I: Day 22 — Seronegative | 98 |
| Anti-AUX-I: Day 43 — Seropositive | 138 |
| Anti-AUX-I: Day 43 — Seronegative | 5 |
| Anti-AUX-I: Day 90 — Seropositive | 131 |
| Anti-AUX-I: Day 90 — Seronegative | 0 |
| Anti-AUX-I: Day 180 — Seropositive | 130 |
| Anti-AUX-I: Day 180 — Seronegative | 5 |
Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
| log 10 titer | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Anti-AUX-II: Day 1 positive | 1.607 ± 0.947 |
| Anti-AUX-II: Day 22 positive | 1.942 ± 1.068 |
| Anti-AUX-II: Day 43 positive | 3.641 ± 1.068 |
| Anti-AUX-II: Day 90 positive | 5.255 ± 0.809 |
| Anti-AUX-II: Day 180 positive | 5.141 ± 0.913 |
A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the highest and lowest quartiles at Day 90 (Q1 and Q4) of seropositive participants at each of two visits (Day 90 and Day 180).
| Participants | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| anti-AUX-I Neutralizing Antibody: Day 1 — Positive | 0 |
| anti-AUX-I Neutralizing Antibody: Day 1 — Negative | 1 |
| anti-AUX-I Neutralizing Antibody: Day 90 — Positive | 26 |
| anti-AUX-I Neutralizing Antibody: Day 90 — Negative | 8 |
| anti-AUX-I Neutralizing Antibody: Day 180 — Positive | 19 |
| anti-AUX-I Neutralizing Antibody: Day 180 — Negative | 14 |
A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the study. Number of Participants Analyzed is determined by observed participants that had a seropositive sample at each visit and the antibody level at Day 71 in Q1 and Q4.
| Participants | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| anti-AUX-II Neutralizing Antibodies: Day 1 — Positive | 1 |
| anti-AUX-II Neutralizing Antibodies: Day 1 — Negative | 0 |
| anti-AUX-II Neutralizing Antibodies: Day 90 — Positive | 24 |
| anti-AUX-II Neutralizing Antibodies: Day 90 — Negative | 8 |
| anti-AUX-II Neutralizing Antibodies: Day 180 — Positive | 20 |
| anti-AUX-II Neutralizing Antibodies: Day 180 — Negative | 11 |
Collected over All (serious and non-serious) AEs, from Day 1 up to Day 180. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | 0/158 (0%) | 1/158 (0.6%) | 158/158 (100%) |
| Event | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 1/158 |
| Event | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Injection site bruisingGeneral disorders | 136/158 |
| Injection site painGeneral disorders | 76/158 |
| Injection site swellingGeneral disorders | 35/158 |
| Injection site pruritusGeneral disorders | 27/158 |
| Injection site discolourationGeneral disorders | 26/158 |
| Injection site noduleGeneral disorders | 23/158 |
| Injection site warmthGeneral disorders | 18/158 |
| Injection site haemorrhageGeneral disorders | 17/158 |
| Injection site massGeneral disorders | 10/158 |
| Hemosiderin stainSkin and subcutaneous tissue disorders | 8/158 |
| Age, Continuous(years) | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Mean | 44.8 ± 10.41 |
| Sex: Female, Male(Participants) | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Female | 158 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Hispanic or Latino | 44 |
| Not Hispanic or Latino | 114 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 17 |
| White | 135 |
| More than one race | 4 |
| Unknown or Not Reported | 0 |
| Body Mass Index (BMI)(kg/m^2) | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| Mean | 26.74 ± 5.259 |
| Skin Category (Fitzpatrick Scale)(Participants) | Collagenase Clostridium Histolyticum (CCH) |
|---|---|
| I (Pale White) | 3 |
| II (Fair) | 34 |
| III (Darker White) | 53 |
| IV (Light Brown) | 48 |
| V (Brown) | 10 |
| VI (Dark Brown) | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Microbial Collagenase