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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EN3835 Active | Active Comparator | EN3835 0.84mg (Collagenase Clostridium Histolyticum) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EN3835 | Biological | Collagenase clostridium histolyticum |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 2-level Composite Responders for the Target Buttock | Proportion 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 2-level composite responder is defined as a participant with 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. A participant who missed one or two assessments of CR-PCSS and PR-PCSS at Day 71 was defined as a non-responder. | Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 71 |
| 2-level PR-PCSS Responders of the Target Buttock |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 - Day 71 |
| Overall Antibody Titer Levels by Visit |
Inclusion Criteria:
Voluntarily sign and date an informed consent agreement
Be a female ≥18 years of age
At Screening visit, have 2 bilateral buttocks with each buttock having:
At Day 1 visit, have 2 bilateral buttocks with each buttock having:
Be willing to apply sunscreen to the buttocks 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
Have a negative serum pregnancy test at Screening and a negative urine pregnancy test before injection of study drug and be using a stable and effective contraception method (eg, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or double barrier method) 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
Be willing and able to cooperate with the requirements of the study
Be able to read, complete and understand the patient-reported outcomes rating instruments in English
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:
Is presently nursing or providing breast milk
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
Intends to use tanning spray or tanning booths 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
Was a subject in a previous cellulite clinical trial of CCH: AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, EN3835-202, and/or EN3835-205
Any other condition(s) that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study
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| Name | Affiliation | Role |
|---|---|---|
| Michael McLane | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endo Clinical Trial Site #1 | Glendale | Arizona | 85308 | United States | ||
| Endo Clinical Trial Site #2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33840781 | Derived | Kaufman-Janette J, Joseph JH, Kaminer MS, Clark J, Fabi SG, Gold MH, Goldman MP, Katz BE, Peddy K, Schlessinger J, Young VL, Davis M, Hurley D, Liu G, McLane MP, Vijayan S, Bass LS. Collagenase Clostridium Histolyticum-aaes for the Treatment of Cellulite in Women: Results From Two Phase 3 Randomized, Placebo-Controlled Trials. Dermatol Surg. 2021 May 1;47(5):649-656. doi: 10.1097/DSS.0000000000002952. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Collagenase Clostridium Histolyticum (CCH) | CCH 0.84 mg/Buttock 1.68 mg Total Dose |
| FG001 | Placebo | Placebo-control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2018 |
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| Placebo |
| Biological |
Placebo |
|
Improvement in cellulite severity of the Target Buttock from baseline of at least 2-levels 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). |
| 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). | Day 71 |
| 2-level Composite Responders 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). | 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. | 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 is defined as a participant with a reduction in the PR-CIS total score of at least 12 from baseline at evaluation time point. A negative change from baseline indicates an improvement in cellulite severity. | Day 71 |
| 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 ≥1-level improvement (Improved, Much Improved or Very Improved) in S-GAIS assessment of the Target Buttock. | 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 ≥ 2-level improvement (Much Improved or Very Much Improved) in S-GAIS assessment of the Target Buttock. | 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 ratings range from "0" (None) to "4" (Severe). | Day 71 |
| Subjects Satisfaction With Cellulite Treatment | 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. | Day 71 |
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.
| 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. | Day 71 |
| North Little Rock |
| Arkansas |
| 72116 |
| United States |
| Endo Clinical Trial Site #3 | Beverly Hills | California | 90210 | United States |
| Endo Clinical Trial Site #4 | Murrieta | California | 92562 | United States |
| Endo Clinical Trial Site #5 | Newport Beach | California | 92663 | United States |
| Endo Clinical Trial Site #6 | San Diego | California | 92121 | United States |
| Endo Clinical Trial Site #7 | Greenwood Village | Colorado | 80111 | United States |
| Endo Clinical Trial Site #8 | Coral Gables | Florida | 33146 | United States |
| Endo Clinical Trial Site #9 | Miami | Florida | 33137 | United States |
| Endo Clinical Trial Site #10 | Nampa | Idaho | 83651 | United States |
| Endo Clinical Trial Site #11 | Carmel | Indiana | 46032 | United States |
| Endo Clinical Trial Site #12 | Metairie | Louisiana | 70006 | United States |
| Endo Clinical Trial Site #13 | New Orleans | Louisiana | 70124 | United States |
| Endo Clinical Trial Site #14 | Warren | Michigan | 48088 | United States |
| Endo Clinical Trial Site #15 | Montclair | New Jersey | 07042 | United States |
| Endo Clinical Trial Site #16 | East Setauket | New York | 11733 | United States |
| Endo Clinical Trial Site #17 | New York | New York | 10016 | United States |
| Endo Clinical Trial Site #18 | Cincinnati | Ohio | 45212 | United States |
| Endo Clinical Trial Site #19 | Nashville | Tennessee | 37215 | United States |
| Endo Clinical Trial Site #20 | Austin | Texas | 78759 | United States |
| Endo Clinical Trial Site #21 | Beaumont | Texas | 77701 | United States |
| Endo Clinical Trial Site #22 | Houston | Texas | 77494 | United States |
| Endo Clinical Trial Site #23 | San Antonio | Texas | 78229 | United States |
| Endo Clinical Trial Site #24 | Salt Lake City | Utah | 84101 | United States |
| Endo Clinical Trial Site #25 | Lynchburg | Virginia | 24501 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Collagenase Clostridium Histolyticum (CCH) | CCH 0.84 mg/Buttock 1.68 mg Total Dose |
| BG001 | Placebo | Placebo-control |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Skin Category (Fitzpatrick Scale) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 2-level Composite Responders for the Target Buttock | Proportion 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 2-level composite responder is defined as a participant with 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. A participant who missed one or two assessments of CR-PCSS and PR-PCSS at Day 71 was defined as a non-responder. | ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population. | Posted | Count of Participants | Participants | Day 71 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population. | Posted | Count of Participants | Participants | Day 71 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 2-level PR-PCSS Responders of the Target Buttock | Improvement in cellulite severity of the Target Buttock from baseline of at least 2-levels 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). | ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population. | Posted | Count of Participants | Participants | Day 71 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population. | Posted | Count of Participants | Participants | Day 71 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 2-level Composite Responders 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). | ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population. | Posted | Count of Participants | Participants | Day 71 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population. | Posted | Count of Participants | Participants | Day 71 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 is defined as a participant with a reduction in the PR-CIS total score of at least 12 from baseline at evaluation time point. A negative change from baseline indicates an improvement in cellulite severity. | ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population. | Posted | Mean | Standard Deviation | score on a scale | Day 71 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 ≥1-level improvement (Improved, Much Improved or Very Improved) in S-GAIS assessment of the Target Buttock. | ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population. | Posted | Count of Participants | Participants | Day 71 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 ≥ 2-level improvement (Much Improved or Very Much Improved) in S-GAIS assessment of the Target Buttock. | ITT Population includes all randomized participants who had at least 1 injection of study drug. All demographic and baseline characteristic summaries were based on this population. The primary and key secondary efficacy parameters were summarized based on this population. | Posted | Count of Participants | Participants | Day 71 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 ratings range from "0" (None) to "4" (Severe). | mITT Population includes all ITT participants with a baseline and at least 1 post-injection evaluation of both the CR-PCSS and PR-PCSS for both the target and non-target buttocks. All secondary and supportive efficacy evaluations were based on the mITT Population. | Posted | Count of Participants | Participants | Day 71 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subjects Satisfaction With Cellulite Treatment | 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. | mITT Population includes all ITT participants with a baseline and at least 1 post-injection evaluation of both the CR-PCSS and PR-PCSS for both the target and non-target buttocks. All secondary and supportive efficacy evaluations were based on the mITT Population. | Posted | Count of Participants | Participants | Day 71 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Safety Population includes all participants who received at least 1 dose of CCH in this study. All safety parameters were summarized based on this population. | Posted | Count of Participants | Participants | Day 1 - Day 71 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Safety Population includes all participants who received at least 1 dose of CCH in this study. All safety parameters were summarized based on this population. | Posted | Mean | Standard Deviation | log 10 titer | Day 1 - Day 71 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Safety Population includes all participants who received at least 1 dose of CCH in this study. All safety parameters were summarized based on this population. | Posted | Count of Participants | Participants | Day 71 |
|
|
All (serious and nonserious) AEs, from Day 1 to Day 71
All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Collagenase Clostridium Histolyticum (CCH) | CCH 0.84 mg/Buttock 1.68 mg Total Dose | 0 | 214 | 1 | 214 | 203 | 214 |
| EG001 | Placebo | Placebo-control | 0 | 206 | 0 | 206 | 64 | 206 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Injection site discolouration | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Injection site mass | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA (19.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saji Vijayan, MBBS | Endo Pharmaceuticals | 800-462-3636 | ClinicalTrials@Endo.com |
| Aug 5, 2020 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| II (Fair) |
|
| III (Darker White) |
|
| IV (Light Brown) |
|
| V (Brown) |
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| VI (Dark Brown) |
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| Participants |
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| OG004 |
| Day 43: CCH |
Day 43 for CCH Treated Group |
| OG005 | Day 43: Placebo | Day 43 for Placebo Group |
| OG006 | Day 71: CCH | Day 71 for CCH Treated Group |
| OG007 | Day 71: Placebo | Day 71 for Placebo Group |
| OG008 | Day 71: CCH (LOCF) | Day 71 for CCH Treated Group (Last Observation Carried Forward) |
| OG009 | Day 71: Placebo (LOCF) | Day 71 for Placebo Group (Last Observation Carried Forward) |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
|
|
|
| Almost None (1) |
|
| Mild (2) |
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| Moderate (3) |
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| Severe (4) |
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| Seronegative |
|
| Title | Measurements |
|---|---|
| Seropositive |
|
| Seronegative |
|
| Title | Measurements |
|---|---|
| Seropositive |
|
| Seronegative |
|
| Title | Measurements |
|---|---|
| Seropositive |
|
| Seronegative |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|