Clinical trial NCT03329989: Safety and Effectiveness of EN3835 in the Treatment of EFP in Women
Official title: A Phase 2 Open-Label Study of EN3835 In The Treatment of Edematous Fibrosclerotic Panniculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Edematous Fibrosclerotic Panniculopathy
Cellulite
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
timeFrame: Day 22, 43, 90, and 180
Secondary outcomes:
measure: Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
timeFrame: Day 22, 43, 90, and 180
measure: Subject Satisfaction With Cellulite Treatment Assessment at End of Study
timeFrame: Day 180
Other outcomes:
measure: Overall Anti-AUX-I Serum Antibody by Visit
timeFrame: Day 1 to Day 180
measure: Overall Anti-AUX-I Antibody Log Titer Levels by Visit
timeFrame: Day 1 to Day 180
measure: Overall Anti-AUX-II Serum Antibody by Visit
timeFrame: Day 1 to Day 180
measure: Overall Anti-AUX-II Antibody Log Titer Levels by Visit
timeFrame: Day 1 to Day 180
measure: Anti-AUX-I Neutralizing Antibodies by Visit
timeFrame: Day 1 to Day 180
measure: Anti-AUX-II Neutralizing Antibodies by Visit
timeFrame: Day 1 to Day 180
Locations:
city: Scottsdale
country: United States
facility: Endo Clinical Trial Site #1
state: Arizona
city: Huntington Beach
country: United States
facility: Endo Clinical Trial Site #2
state: California
city: San Diego
country: United States
facility: Endo Clinical Trial Site #3
state: California
city: Santa Monica
country: United States
facility: Endo Clinical Trial Site #4
state: California
city: Coral Gables
country: United States
facility: Endo Clinical Trial Site #5
state: Florida
city: Tampa
country: United States
facility: Endo Clinical Trial Site #6
state: Florida
city: West Palm Beach
country: United States
facility: Endo Clinical Trial Site #7
state: Florida
city: Alpharetta
country: United States
facility: Endo Clinical Trial Site #8
state: Georgia
city: New York
country: United States
facility: Endo Clinical Trial Site #9
state: New York
city: Franklin
country: United States
facility: Endo Clinical Trial Site #10
state: Tennessee
city: Austin
country: United States
facility: Endo Clinical Trial Site #11
state: Texas
Study officials:
affiliation: Endo Pharmaceuticals
name: Mike McLane, PhD
role: STUDY_DIRECTOR
References: