A Phase 3 interventional study of EN3835 and Placebo in Edematous Fibrosclerotic Panniculopathy (Cellulite), sponsored by Endo Pharmaceuticals. Completed at 26 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Phase 3, Interventional, and Treatment
Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed, subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days 1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the buttocks will be at the discretion of the Investigator. End of study will occur at study day 71.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 423 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 2 bilateral buttocks with each buttock having:
At Day 1 visit, have 2 bilateral buttocks with each buttock having:
Exclusion Criteria:
Has any of the following systemic conditions:
Has any of the following local conditions in the areas 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 a 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: EN3835
Biological: Placebo
Collagenase clostridium histolyticum
Placebo
2-level Composite Responders for the Target Buttock
Number of of 2-level Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) / Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) composite responders in the target buttock at Day 71. CR-PCSS and PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). A participant who missed one or two assessments of CR-PCSS and PR-PCSS at Day 71 was defined as a non-responder. A 2-level composite responder is defined as a participant with an improvement from baseline of at least 2-levels of severity in the CR-PCSS and an improvement from baseline of at least 2-levels of severity in the PR-PCSS of the target buttock.
Time frame: Day 71
1-level PR-PCSS Responders of the Target Buttock
Improvement in cellulite severity of the Target Buttock from baseline of at least 1-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS). PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).
Time frame: Day 71
2-level PR-PCSS Responders of the Target Buttock
Improvement in cellulite severity of the Target Buttock from baseline of at least 2-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS). PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).
Time frame: Day 71
1-level Composite Responders of the Target Buttock
Improvement in cellulite severity of the Target Buttock from baseline of at least 1-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) / Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). PR-PCSS and CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).
Time frame: Day 71
2-level Composite Responder of the Non-target Buttock
Improvement in cellulite severity of the Non-target Buttock from baseline of at least 2-levels of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) / Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). PR-PCSS and CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).
Time frame: Day 71
1-level SSRS Responders
Subject Self-Rating Scale (SSRS) is a measure that assesses participant satisfaction with appearance in association with cellulite on the buttocks using whole numbers on a 7-level scale that ranges from "0" (Extremely Dissatisfied) to "6" (Extremely Satisfied). A 1-level SSRS responder is defined as a participant who is at least slightly satisfied (Slightly Satisfied \[4\], Very Satisfied \[5\], or Extremely Satisfied \[6\]) with the appearance of the cellulite on her buttocks at Day 71.
Time frame: Day 71
Change From Baseline in PR-CIS Total Score
Patient Reported Cellulite Impact Scale (PR-CIS) is a 6-item static questionnaire, each item is answered by a participant on a 11-level numerical rating scale that ranges from "0" (Not at all) to "10" (Extremely). The PR-CIS total score is the sum of individual item scores and can range from "0" to "60" with higher numbers reflecting a more negative impact from the cellulite. A responder was defined as a participant with a reduction in the PR-CIS total score of at least 12 from baseline at an evaluation time point. A negative change from baseline indicates an improvement in cellulite severity.
Time frame: 71 Days
1-level S-GAIS Responders of Target Buttock
Subject Global Aesthetic Improvement Scale (S-GAIS) is a measure that assesses participant rating of cellulite appearance after treatment. This scale has 7-levels ranging from "+3" (Very Much Improved) to "-3" (Very Much Worse). Responders are defined as participants with at least ≥ 1-level improvement (Improved, Much Improved or Very Much Improved) in S-GAIS assessment of the Target Buttock.
Time frame: Day 71
2-level S-GAIS Responders of Target Buttock
Subject Global Aesthetic Improvement Scale (S-GAIS) is a measure that assesses participant rating of cellulite appearance after treatment. This scale has 7-levels ranging from "+3" (Very Much Improved) to "-3" (Very Much Worse). Responders are defined as participants with at least ≥ 2-level improvement (Much Improved or Very Much Improved) in S-GAIS assessment of the Target Buttock.
Time frame: Day 71
PR-PCSS Rating for the Target and Non-target Buttock by Visit
The Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level photonumeric scale used by the patient (participant) to assess the severity of the participant's cellulite. The scale ratings range from "0" (None) to "4" (Severe).
Time frame: Day 1 to Day 71
Subjects Satisfaction With Cellulite Treatment at Day 71
A 1-level Subject Satisfaction responder is defined as a participant who is at least Satisfied (Satisfied \[+1\], or Very Satisfied \[+2\]) with the appearance of the cellulite on her buttocks at the Day 71 visit. A positive change indicates an improvement in cellulite.
Time frame: Day 71
Serum Antibody Positivity by Visit
Percent of participants that are seropositive. Percentages were based on the number of subjects who had immunogenicity lab samples analyzed at the visit.
Time frame: Day 1 - Day 71
Overall Antibody Titer Levels by Visit
Descriptive statistics were based on log10 transformation of titer levels. Titer levels were imputed as 10 before the transformation if the reported level is "\<10". Only seropositive participants are summarized.
Time frame: Day 1 - Day 71
Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles
Q1 and Q4 are based on the ADA titer levels.
Time frame: Day 71
| Milestone | Collagenase Clostridium Histolyticum (CCH) | Placebo |
|---|---|---|
| Started | 210 | 213 |
| Completed | 186 | 192 |
| Not completed | 24 | 21 |
| Withdrew: Withdrawal by subject | 11 | 10 |
| Withdrew: Lost to follow-up | 3 | 9 |
| Withdrew: Adverse event | 9 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Administrative | 0 | 1 |
Number of of 2-level Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) / Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) composite responders in the target buttock at Day 71. CR-PCSS and PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). A participant who missed one or two assessments of CR-PCSS and PR-PCSS at Day 71 was defined as a non-responder. A 2-level composite responder is defined as a participant with an improvement from baseline of at least 2-levels of severity in the CR-PCSS and an improvement from baseline of at least 2-levels of severity in the PR-PCSS of the target buttock.
| Participants | Collagenase Clostridium Histolyticum (CCH) | Placebo |
|---|---|---|
| Yes: 2-Level Improvement | 16 | 4 |
| No: 2-Level Improvement | 194 | 209 |
Improvement in cellulite severity of the Target Buttock from baseline of at least 1-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS). PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).
| Participants | Collagenase Clostridium Histolyticum (CCH) | Placebo |
|---|---|---|
| Yes | 114 | 77 |
| No | 96 | 136 |
Improvement in cellulite severity of the Target Buttock from baseline of at least 2-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS). PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).
| Participants | Collagenase Clostridium Histolyticum (CCH) | Placebo |
|---|---|---|
| Yes | 51 | 26 |
| No | 159 | 187 |
Improvement in cellulite severity of the Target Buttock from baseline of at least 1-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) / Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). PR-PCSS and CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).
| Participants | Collagenase Clostridium Histolyticum (CCH) | Placebo |
|---|---|---|
| Yes | 78 | 38 |
| No | 132 | 175 |
Improvement in cellulite severity of the Non-target Buttock from baseline of at least 2-levels of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) / Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). PR-PCSS and CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).
| Participants | Collagenase Clostridium Histolyticum (CCH) | Placebo |
|---|---|---|
| Yes | 16 | 2 |
| No | 194 | 211 |
Subject Self-Rating Scale (SSRS) is a measure that assesses participant satisfaction with appearance in association with cellulite on the buttocks using whole numbers on a 7-level scale that ranges from "0" (Extremely Dissatisfied) to "6" (Extremely Satisfied). A 1-level SSRS responder is defined as a participant who is at least slightly satisfied (Slightly Satisfied \[4\], Very Satisfied \[5\], or Extremely Satisfied \[6\]) with the appearance of the cellulite on her buttocks at Day 71.
| Participants | Collagenase Clostridium Histolyticum (CCH) | Placebo |
|---|---|---|
| 1-level SSRS Responders | 102 | 48 |
Patient Reported Cellulite Impact Scale (PR-CIS) is a 6-item static questionnaire, each item is answered by a participant on a 11-level numerical rating scale that ranges from "0" (Not at all) to "10" (Extremely). The PR-CIS total score is the sum of individual item scores and can range from "0" to "60" with higher numbers reflecting a more negative impact from the cellulite. A responder was defined as a participant with a reduction in the PR-CIS total score of at least 12 from baseline at an evaluation time point. A negative change from baseline indicates an improvement in cellulite severity.
| score on a scale | Collagenase Clostridium Histolyticum (CCH) | Placebo |
|---|---|---|
| Baseline (Day 1) | 51.1 ± 8.86 | 51.6 ± 9.77 |
| Day 71 | 40.2 ± 13.27 | 45.7 ± 12.93 |
| Change from Baseline | -10.9 ± 12.51 | -5.9 ± 11.62 |
Subject Global Aesthetic Improvement Scale (S-GAIS) is a measure that assesses participant rating of cellulite appearance after treatment. This scale has 7-levels ranging from "+3" (Very Much Improved) to "-3" (Very Much Worse). Responders are defined as participants with at least ≥ 1-level improvement (Improved, Much Improved or Very Much Improved) in S-GAIS assessment of the Target Buttock.
| Participants | Collagenase Clostridium Histolyticum (CCH) | Placebo |
|---|---|---|
| 1-level S-GAIS Responders of Target Buttock | 135 | 82 |
Subject Global Aesthetic Improvement Scale (S-GAIS) is a measure that assesses participant rating of cellulite appearance after treatment. This scale has 7-levels ranging from "+3" (Very Much Improved) to "-3" (Very Much Worse). Responders are defined as participants with at least ≥ 2-level improvement (Much Improved or Very Much Improved) in S-GAIS assessment of the Target Buttock.
| Participants | Collagenase Clostridium Histolyticum (CCH) | Placebo |
|---|---|---|
| 2-level S-GAIS Responders of Target Buttock | 49 | 13 |
The Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level photonumeric scale used by the patient (participant) to assess the severity of the participant's cellulite. The scale ratings range from "0" (None) to "4" (Severe).
| Participants | Day 1: CCH | Day 1: Placebo | Day 22: CCH | Day 22: Placebo | Day 43: CCH | Day 43: Placebo | Day 71: CCH | Day 71: Placebo | Day 71: CCH (LOCF) | Day 71: Placebo (LOCF) |
|---|---|---|---|---|---|---|---|---|---|---|
| Target Buttock Rating — None (0) | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 2 |
| Target Buttock Rating — Almost None (1) | 0 | 0 | 1 | 0 | 13 | 4 | 25 | 5 | 25 | 5 |
| Target Buttock Rating — Mild (2) | 0 | 0 | 29 | 7 | 50 | 24 | 54 | 38 | 58 | 40 |
| Target Buttock Rating — Moderate (3) | 84 | 82 | 79 | 95 | 75 | 95 | 65 | 77 | 72 | 81 |
| Target Buttock Rating — Severe (4) | 117 | 123 | 78 | 100 | 50 | 71 | 40 | 67 | 46 | 77 |
| Nontarget Buttock Rating — None (0) | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 2 | 1 | 2 |
| Nontarget Buttock Rating — Almost None (1) | 0 | 0 | 2 | 0 | 12 | 4 | 20 | 7 | 21 | 7 |
| Nontarget Buttock Rating — Mild (2) | 0 | 0 | 27 | 9 | 50 | 33 | 55 | 34 | 59 | 35 |
| Nontarget Buttock Rating — Moderate (3) | 81 | 83 | 81 | 89 | 80 | 82 | 63 | 88 | 70 | 93 |
| Nontarget Buttock Rating — Severe (4) | 120 | 122 | 77 | 104 | 45 | 75 | 45 | 59 | 50 | 68 |
A 1-level Subject Satisfaction responder is defined as a participant who is at least Satisfied (Satisfied \[+1\], or Very Satisfied \[+2\]) with the appearance of the cellulite on her buttocks at the Day 71 visit. A positive change indicates an improvement in cellulite.
| Participants | Day 71: CCH | Day 71: Placebo | Day 71: CCH (LOCF) | Day 71: Placebo (LOCF) |
|---|---|---|---|---|
| Very Satisfied (+2) | 24 | 7 | 24 | 7 |
| Satisfied (+1) | 76 | 42 | 80 | 42 |
| Neither Satisfied Nor Dissatisfied (0) | 46 | 56 | 52 | 56 |
| Dissatisfied (-1) | 23 | 42 | 23 | 42 |
| Very Dissatisfied (-2) | 15 | 43 | 16 | 44 |
Percent of participants that are seropositive. Percentages were based on the number of subjects who had immunogenicity lab samples analyzed at the visit.
| Participants | Anti-AUX-I: CCH | Anti-AUX-I: Placebo | Anti-AUX-II: CCH | Anti-AUX-II: Placebo |
|---|---|---|---|---|
| Day 1 — Seropositive | 12 | 5 | 11 | 9 |
| Day 1 — Seronegative | 197 | 207 | 198 | 203 |
| Day 22 — Seropositive | 97 | 5 | 49 | 9 |
| Day 22 — Seronegative | 90 | 195 | 138 | 191 |
| Day 43 — Seropositive | 186 | 6 | 180 | 10 |
| Day 43 — Seronegative | 2 | 188 | 8 | 184 |
| Day 71 — Seropositive | 185 | 10 | 185 | 12 |
| Day 71 — Seronegative | 0 | 182 | 0 | 180 |
Descriptive statistics were based on log10 transformation of titer levels. Titer levels were imputed as 10 before the transformation if the reported level is "\<10". Only seropositive participants are summarized.
| log 10 titer | Anit-AUX-I: CCH | Anti-AUX-I: Placebo | Anti-AUX-II: CCH | Anti-AUX-II: Placebo |
|---|---|---|---|---|
| Day 1 positive | 4.396 ± 2.2644 | 3.682 ± 2.2514 | 4.366 ± 2.1658 | 2.478 ± 1.6280 |
| Day 22 positive | 2.561 ± 1.7812 | 3.428 ± 2.3377 | 2.599 ± 2.1305 | 2.693 ± 1.7244 |
| Day 43 positive | 4.639 ± 0.9961 | 2.597 ± 1.5802 | 3.706 ± 1.2138 | 2.052 ± 1.3049 |
| Day 71 positive | 6.011 ± 0.6758 | 1.845 ± 1.3931 | 5.266 ± 0.7549 | 1.927 ± 1.3274 |
Q1 and Q4 are based on the ADA titer levels.
| Participants | CCH: Q1 | CCH: Q4 | CCH: Total |
|---|---|---|---|
| Neutralizing AUX-I Antibody — Negative | 16 | 0 | 16 |
| Neutralizing AUX-I Antibody — Positive | 8 | 24 | 32 |
| Neutralizing AUX-II Antibody — Negative | 10 | 0 | 10 |
| Neutralizing AUX-II Antibody — Positive | 13 | 23 | 36 |
Collected over All (serious and nonserious) AEs, from Day 1 to Day 71. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | 0/210 (0%) | 0/210 (0%) | 166/210 (79%) |
| Placebo | 0/213 (0%) | 1/213 (0.5%) | 55/213 (25.8%) |
| Event | Collagenase Clostridium Histolyticum (CCH) | Placebo |
|---|---|---|
| Colitis ischaemicGastrointestinal disorders | 0/210 | 1/213 |
| Event | Collagenase Clostridium Histolyticum (CCH) | Placebo |
|---|---|---|
| Injection site bruisingGeneral disorders | 137/210 | 42/213 |
| Injection site painGeneral disorders | 76/210 | 11/213 |
| Injection stie noduleGeneral disorders | 38/210 | 0/213 |
| Injection site pruritusGeneral disorders | 29/210 | 1/213 |
| Injection site haemorrhageGeneral disorders | 25/210 | 5/213 |
| Injection site massGeneral disorders | 18/210 | 1/213 |
| Injection site swellingGeneral disorders | 15/210 | 0/213 |
| Injection site discolourationGeneral disorders | 12/210 | 0/213 |
| Age, Continuous(years) | Collagenase Clostridium Histolyticum (CCH) | Placebo | Total |
|---|---|---|---|
| Mean | 47.9 ± 10.33 | 45.8 ± 9.84 | 46.9 ± 10.13 |
| Sex: Female, Male(Participants) | Collagenase Clostridium Histolyticum (CCH) | Placebo | Total |
|---|---|---|---|
| Female | 210 | 213 | 423 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Collagenase Clostridium Histolyticum (CCH) | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 31 | 41 | 72 |
| Not Hispanic or Latino | 179 | 172 | 351 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Collagenase Clostridium Histolyticum (CCH) | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 47 | 43 | 90 |
| White | 157 | 161 | 318 |
| More than one race | 3 | 4 | 7 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Body Mass Index (BMI)(kg/m^2) | Collagenase Clostridium Histolyticum (CCH) | Placebo | Total |
|---|---|---|---|
| Mean | 31.04 ± 7.358 | 30.97 ± 6.856 | 31.00 ± 7.102 |
| Skin Category (Fitzpatrick Scale)(Participants) | Collagenase Clostridium Histolyticum (CCH) | Placebo | Total |
|---|---|---|---|
| I (Pale White) | 5 | 4 | 9 |
| II (Fair) | 50 | 48 | 98 |
| III (Darker White) | 69 | 75 | 144 |
| IV (Light Brown) | 40 | 35 | 75 |
| V (Brown) | 33 | 27 | 60 |
| VI (Dark Brown) | 13 | 24 | 37 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Microbial Collagenase