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The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as Cellulite).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EN3835 Active | Experimental | EN3835 0.84 mg (Collagenase Clostridium Histolyticum). Each subject can receive up to three treatment sessions. Each treatment session will be separated by approximately 21 days. |
|
| EN3835 Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COLLAGENASE CLOSTRIDIUM HISTOLYTICUM | Biological | Injectable intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Composite Responders of at Least 2-Level Improvement of Severity | Percentage of composite responders defined as subjects with an improvement from baseline of at least 2-levels of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement on each scale for example would represent a change from a 4 (severe) to a 2 (mild). In order to be considered a responder a subject needs to have at least a 2-level improvement on both scales. | Baseline, Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Composite Responders of at Least 1-Level Improvement of Severity | Percentage of composite responders defined as subjects with improvement from baseline of at least 1-level of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement on each scale for example would represent a change from a 4 (severe) to a 3 (moderate). In order to be considered a responder a subject needs to have at least a 1-level improvement on both scales. |
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Inclusion Criteria:
Be a female ≥18 years of age
At Screening visit, have at least 1 quadrant with:
At Day 1 visit, have an assigned quadrant with:
Be willing to apply sunscreen to the selected treatment quadrant 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 urine pregnancy test at screening and be using an 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
Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC).
Be able to read, complete and understand the Patient Reported Outcomes rating instruments in English
Exclusion Criteria:
Has any of the following conditions:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Testing of Beverly Hills | Beverly Hills | California | 90210 | United States | ||
| Dermatology Specialists, Inc |
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| ID | Title | Description |
|---|---|---|
| FG000 | EN3835 0.84 mg | Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days. Injectable intervention |
| FG001 | Placebo | Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo Comparator | Biological |
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| Baseline, Day 71 |
| CR-PCSS Responder Analysis: 2-Levels of Severity | Percentage of subjects with improvement from baseline of at least 2-levels of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild). | Baseline, Day 71 |
| CR-PCSS Responder Analysis: 1-Level of Severity | Percentage of subjects with improvement from baseline of at least 1-level of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate). | Baseline, Day 71 |
| CR-PCSS Change From Baseline | The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity. | Baseline, Day 71 |
| PR-PCSS Responder Analysis: 2-Levels of Severity | Percentage of subjects with improvement from baseline of at least 2-levels of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild). | Baseline, Day 71 |
| PR-PCSS Responder Analysis: 1-Level of Severity | Percentage of subjects with improvement from baseline of at least 1-level of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate). | Baseline, Day 71 |
| PR-PCSS Change From Baseline | The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity. | Baseline, Day 71 |
| Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | On Day 71, the Investigator determined the degree of improvement from baseline in the treated area using the 7-point I-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3). | Day 71 |
| Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | At Day 71, subjects were asked to rate their opinion of the overall improvement of their treated area using the 7-point S-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3) | Day 71 |
| Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | At Day 71, subjects were asked to rate their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings could be satisfied (+1), very satisfied (+2), neither satisfied nor dissatisfied (0), or dissatisfied (-1), very dissatisfied (-2). | Day 71 |
| Change in the Hexsel Cellulite Severity Scale (CSS) Total Score | Investigator used the Hexsel CSS to assess the severity of cellulite. The total score could range from 0 (no cellulite) to 15 (extremely severe cellulite). Negative change in Hexsel CSS total score indicates an improvement in cellulite severity | Baseline, Day 71 |
| Murrieta |
| California |
| 92562 |
| United States |
| Dermatology Specialists, Inc | Oceanside | California | 92056 | United States |
| Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc | San Diego | California | 92121 | United States |
| Olympian Clinical Research | Clearwater | Florida | 33756 | United States |
| Skin Research Institute LLC | Coral Gables | Florida | 33146 | United States |
| Research Institute of the Southeast | West Palm Beach | Florida | 33401 | United States |
| Mercy Health Research | Washington | Missouri | 10075 | United States |
| Bass Plastic Surgery, PLLC | New York | New York | 10065 | United States |
| Sadick Research Group | New York | New York | 10075 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Austin Institute for Clinical Research | Pflugerville | Texas | 78660 | United States |
| Charlottesville Medical Research Center LLC | Charlottesville | Virginia | 22911 | United States |
| The Education & Research Foundation | Lynchburg | Virginia | 24501 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Analysis based on intent-to-treat (ITT) population; all randomized subjects who received at least 1 injection of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | EN3835 0.84 mg | Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days. Injectable intervention |
| BG001 | Placebo | Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Participants |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Percentage of Composite Responders of at Least 2-Level Improvement of Severity | Percentage of composite responders defined as subjects with an improvement from baseline of at least 2-levels of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement on each scale for example would represent a change from a 4 (severe) to a 2 (mild). In order to be considered a responder a subject needs to have at least a 2-level improvement on both scales. | Analysis is based on ITT population; all randomized subjects who received at least 1 injection of study medication | Posted | Count of Participants | Participants | Baseline, Day 71 |
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| Secondary | Percentage of Composite Responders of at Least 1-Level Improvement of Severity | Percentage of composite responders defined as subjects with improvement from baseline of at least 1-level of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement on each scale for example would represent a change from a 4 (severe) to a 3 (moderate). In order to be considered a responder a subject needs to have at least a 1-level improvement on both scales. | Analysis is based on ITT population; all randomized subjects who received at least 1 injection of study medication | Posted | Count of Participants | Participants | Baseline, Day 71 |
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| Secondary | CR-PCSS Responder Analysis: 2-Levels of Severity | Percentage of subjects with improvement from baseline of at least 2-levels of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild). | Analysis is based on modified intent-to-treat (mITT) population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS | Posted | Count of Participants | Participants | Baseline, Day 71 |
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| Secondary | CR-PCSS Responder Analysis: 1-Level of Severity | Percentage of subjects with improvement from baseline of at least 1-level of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate). | Analysis is based on modified intent-to-treat (mITT) population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS | Posted | Count of Participants | Participants | Baseline, Day 71 |
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| Secondary | CR-PCSS Change From Baseline | The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity. | Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 71 |
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| Secondary | PR-PCSS Responder Analysis: 2-Levels of Severity | Percentage of subjects with improvement from baseline of at least 2-levels of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild). | Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS | Posted | Count of Participants | Participants | Baseline, Day 71 |
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| Secondary | PR-PCSS Responder Analysis: 1-Level of Severity | Percentage of subjects with improvement from baseline of at least 1-level of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate). | Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS | Posted | Count of Participants | Participants | Baseline, Day 71 |
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| Secondary | PR-PCSS Change From Baseline | The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity. | Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 71 |
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| Secondary | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | On Day 71, the Investigator determined the degree of improvement from baseline in the treated area using the 7-point I-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3). | Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS | Posted | Count of Participants | Participants | No | Day 71 |
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| Secondary | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | At Day 71, subjects were asked to rate their opinion of the overall improvement of their treated area using the 7-point S-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3) | Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS | Posted | Count of Participants | Participants | No | Day 71 |
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| Secondary | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | At Day 71, subjects were asked to rate their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings could be satisfied (+1), very satisfied (+2), neither satisfied nor dissatisfied (0), or dissatisfied (-1), very dissatisfied (-2). | Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS | Posted | Count of Participants | Participants | No | Day 71 |
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| Secondary | Change in the Hexsel Cellulite Severity Scale (CSS) Total Score | Investigator used the Hexsel CSS to assess the severity of cellulite. The total score could range from 0 (no cellulite) to 15 (extremely severe cellulite). Negative change in Hexsel CSS total score indicates an improvement in cellulite severity | Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 71 |
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Baseline, Day 71
Serious Adverse Events by Frequency (Safety Population)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EN3835 0.84 mg | Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days. Injectable intervention | 1 | 189 | 148 | 189 | ||
| EG001 | Placebo | Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention | 0 | 186 | 30 | 186 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Non-systematic Assessment | Serious Adverse Events by Frequency (Safety Population) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA (19.0) | Systematic Assessment | Administration site conditions |
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| Injection site pain | General disorders | MedDRA (19.0) | Systematic Assessment | Administration site conditions |
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| Injection site nodule | General disorders | MedDRA (19.0) | Systematic Assessment | Administration site conditions |
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| Injection site pruritus | General disorders | MedDRA (19.0) | Systematic Assessment | Administration site conditions |
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| Injection site induration | General disorders | MedDRA (19.0) | Systematic Assessment | Administration site conditions |
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| Injection site swelling | General disorders | MedDRA (19.0) | Systematic Assessment | Administration site conditions |
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| Injection site mass | General disorders | MedDRA (19.0) | Systematic Assessment | Administration site conditions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Coordinator | Endo Pharmaceuticals Inc. | clinicalsite.inquires@endo.com |
| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| ID | Term |
|---|---|
| D017364 | Collagenases |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
Not provided
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| 25-34 years |
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| 35-44 years |
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| >=45 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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