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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03329989
Other study ID # EN3835-205
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 17, 2017
Est. completion date September 5, 2018

Study information

Verified date October 2020
Source Endo Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.


Recruitment information / eligibility

Status Completed
Enrollment 158
Est. completion date September 5, 2018
Est. primary completion date September 5, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Voluntarily sign and date an informed consent agreement 2. Be a female =18 years of age 3. At Screening visit, have at least 2 bilateral quadrants with each quadrant having: 1. a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and 2. a Hexsel CSS score no greater than 13 4. At Day 1 visit, have assigned bilateral quadrants with each quadrant having: 1. a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and 2. a Hexsel CSS score no greater than 13 5. Be willing to apply sunscreen to the assigned treatment quadrants before each exposure to the sun while participating in the study (i.e., Screening through end of study) 6. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at Screening 7. 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 (e.g., 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 8. Be willing and able to cooperate with the requirements of the study 9. Be able to read, complete and understand the patient-reported outcomes rating instruments in English Exclusion Criteria: 1. Has any of the following systemic conditions: 1. Coagulation disorder 2. Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years 3. History of keloidal scarring or abnormal wound healing 4. Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. Any questions about concurrent diseases should be discussed with the Medical Monitor. 5. Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values. 2. Has any of the following local conditions in the area to be treated: 1. History of lower extremity thrombosis or post-thrombosis syndrome 2. Vascular disorder (e.g., varicose veins, telangiectasia) in area to be treated 3. Inflammation or active infection 4. Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer 5. Has a tattoo and/or a mole located within 2 cm of the site of injection 3. 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 4. 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: 1. Liposuction in the areas of the body selected for treatment during the 12-month period before injection of study drug 2. Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; buttock and/or thigh implant treatment, or surgery (including subcision and/or powered subcision) within the assigned treatment quadrants during the 12-month period before injection of study drug 3. Endermologie or similar treatments within the assigned treatment quadrants during the 6 month period before injection of study drug 4. Massage therapy within the assigned treatment quadrants during the 3-month period before injection of study drug 5. Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the assigned treatment quadrants during the 2-week period before injection of study drug 5. Is presently nursing or providing breast milk 6. Intends to become pregnant during the study 7. Intends to initiate an intensive sport or exercise program during the study 8. Intends to initiate a weight reduction program during the study 9. Intends to use tanning spray or tanning booths during the study 10. Has received an investigational drug or treatment within 30 days before injection of study drug 11. Has a known systemic allergy to collagenase or any other excipient of study drug 12. Has received any collagenase treatments at any time prior to treatment 13. Was a subject in a previous cellulite clinical trial of collagenase clostridium histolyticum (CCH) : AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, and/or EN3835-202 14. Any other condition(s) that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Collagenase Clostridium Histolyticum
During 3 treatment visits 12 injections will be given per treatment area

Locations

Country Name City State
United States Endo Clinical Trial Site #8 Alpharetta Georgia
United States Endo Clinical Trial Site #11 Austin Texas
United States Endo Clinical Trial Site #5 Coral Gables Florida
United States Endo Clinical Trial Site #10 Franklin Tennessee
United States Endo Clinical Trial Site #2 Huntington Beach California
United States Endo Clinical Trial Site #9 New York New York
United States Endo Clinical Trial Site #3 San Diego California
United States Endo Clinical Trial Site #4 Santa Monica California
United States Endo Clinical Trial Site #1 Scottsdale Arizona
United States Endo Clinical Trial Site #6 Tampa Florida
United States Endo Clinical Trial Site #7 West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. Day 1 to Day 180
Other 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. Day 1 to Day 180
Other 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. Day 1 to Day 180
Other 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. Day 1 to Day 180
Other 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). Day 1 to Day 180
Other 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. Day 1 to Day 180
Primary 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. Day 22, 43, 90, and 180
Secondary 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. Day 22, 43, 90, and 180
Secondary 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. Day 180
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