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Injection Techniques of Collagenase Clostridium Histolyticum (CCH) for the Treatment of EFP (Cellulite)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03632993
Recruitment Status : Completed
First Posted : August 16, 2018
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 5, 2018
First Posted Date  ICMJE August 16, 2018
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE September 18, 2018
Actual Primary Completion Date January 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • The aesthetic appearance improvement from baseline in the 3-D photographic image using the Likert Scale score of aesthetic appearance. [ Time Frame: 71 Days: Subjects who complete the study will participate for up to 92 days including a 21 day screening period, a 43 day active treatment period, and a 28 day follow-up period. ]
    Change from baseline in the Likert Scale score of aesthetic.
  • The change from baseline in the Hexsel CSS (B) depression depth scale [ Time Frame: 71 Days: Subjects who complete the study will participate for up to 92 days including a 21 day screening period, a 43 day active treatment period, and a 28 day follow-up period. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Injection Techniques of Collagenase Clostridium Histolyticum (CCH) for the Treatment of EFP (Cellulite)
Official Title  ICMJE A Phase 2A, Open-Label Study Evaluating the Safety and Different Injection Techniques of CCH for the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP)
Brief Summary The study will evaluate the safety and effectiveness of different injection techniques of Collagenase Clostridium Histolyticum (CCH) for the treatment of adult women with mild, moderate or severe Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Edematous Skin
Intervention  ICMJE Drug: collagenase clostridium histolyticum (CCH)
Endo Pharmaceuticals Inc. (Endo) is developing collagenase clostridium histolyticum (CCH) for the treatment of EFP. Because CCH is a proteinase that can hydrolyze the triple-helical region of collagen under physiological conditions, CCH has the potential to be effective in lysing sub-dermal collagen, such as those observed in the dermal septa, which are the underlying cause of the skin dimpling in women with Edematous Fibrosclerotic Panniculopathy (EFP). CCH targets the collagenase structural matrix (e.g., dermal septa) at the site of injection and does not require systemic exposure to be effective.
Study Arms  ICMJE
  • Active Comparator: Treatment I: CCH Shallow Injection, 3 Aliquots

    In Treatment I, CCH will be injected subcutaneously while the subject lies in a prone position. Each injection will consist of a single skin injection of study drug administered as three 0.1 mL aliquots (for a total injection volume of 0.3 mL).

    During each treatment visit, 8 syringes (4 syringes per treatment area) will be prepared for dosing. Each syringe will contain 0.9 mL of CCH (3 injections in each syringe). Dose per subject per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).

    Intervention: Drug: collagenase clostridium histolyticum (CCH)
  • Active Comparator: Treatment II: CCH Shallow Injection, 1 Aliquot

    In Treatment II, CCH will be injected subcutaneously while the subject is in a prone position. Each injection will consist of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot.

    During each treatment visit, 8 syringes (4 syringes per treatment area) will be prepared for dosing. Each syringe will contain 0.9 mL of CCH (3 injections in each syringe). Dose per subject per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).

    Intervention: Drug: collagenase clostridium histolyticum (CCH)
  • Active Comparator: Treatment III: CCH Deep Injection, 1 Aliquot

    In Treatment III, CCH will be injected subcutaneously while the subject is in a prone position. Each injection will consist of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot.

    During each treatment visit, 8 syringes (4 syringes per treatment area) will be prepared for dosing. Each syringe will contain 0.9 mL of CCH (3 injections in each syringe). Dose per subject per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).

    Intervention: Drug: collagenase clostridium histolyticum (CCH)
  • Active Comparator: Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots

    In Treatment IV, CCH will be injected subcutaneously while the subject lies in a prone position. Each injection will consist of a single skin injection of study drug administered as five 0.3 mL (for a total injection volume of 1.5 mL).

    During each treatment visit, 24 syringes (12 syringes per treatment area) will be prepared for dosing. Each syringe will contain 1.5mL of CCH (5 aliquots of 0.3 mL, for each injection, in each syringe). Dose per subject per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).

    Intervention: Drug: collagenase clostridium histolyticum (CCH)
  • Active Comparator: Treatment V: CCH Shallow Injections, 4 Aliquots

    In Treatment V, CCH will be injected subcutaneously while the subject lies in a prone position. Each injection will receive a single skin injection of study drug administered as four 0.3 mL aliquots (for a total injection volume of 1.2 mL).

    During each treatment visit, 24 syringes (12 syringes per treatment area) will be prepared for dosing. Each syringe will contain 1.2mL of CCH (4 aliquots of 0.3mL each). Dose per subject per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).

    Intervention: Drug: collagenase clostridium histolyticum (CCH)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2018)
64
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
60
Actual Study Completion Date  ICMJE January 24, 2019
Actual Primary Completion Date January 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

No subject will be assigned to treatment until all eligibility criteria have been satisfied. To qualify for the study a subject must:

  1. Be able to provide voluntary written informed consent prior to the initiation of any study specific procedures per the policy of the governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
  2. Be female and at least 18 years of age at the time of consent.
  3. Have evidence of cellulite in 2 bilateral treatment areas (defined as right and left buttocks OR right and left posterolateral thighs) as assessed by the Investigator at the Screening visit, and fulfills the following requirements:

    1. has a score of 2 (mild), 3 (moderate) or 4 (severe) as reported by the Investigator (CR-PCSS) in 2 treatment areas (two thighs or two buttocks) at the Screening Visit.
    2. has at least 2 dimples from each treatment area that:

      • are isolated and separated by at least 5 cm from any other dimples.
      • score 2 or 3 on the Hexsel depression scale.
      • have dimple width: length ratio ≥ 0.5.
  4. Be willing to apply sunscreen to the dosing areas before each exposure to the sun while participating in the study (ie, screening through end of study).
  5. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening.
  6. Have a negative serum pregnancy test at the Screening Visit and negative urine pregnancy at Day 1 (before injection of study drug), be using an effective contraception method (e.g., abstinence, intrauterine device, hormonal [estrogen/progestin] contraceptives, or double barrier control) for at least 1 menstrual cycle prior to study enrollment and through Day 71 ; or be menopausal defined as at least 12 months of amenorrhea in the absence of other biological or physiological causes (as determined by the Investigator), or be post-menopausal for at least 1 year, or be surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation).
  7. Be willing and able to comply with all protocol required study visits and assessments.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

  1. Is pregnant or is intending to become pregnant during the study.
  2. Is presently nursing/breastfeeding or providing breast milk.
  3. 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.
  4. Has any of the following local conditions in the areas to be treated:

    1. History of lower extremity thrombosis or post-thrombosis syndrome.
    2. Vascular disorder (eg, varicose veins, telangiectasia).
    3. Inflammation or active infection.
    4. Severe skin laxity, flaccidity, and/or sagging.
    5. Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer.
  5. Has a tattoo located within 2 cm of the site of injection.
  6. Requires anticoagulant or antiplatelet medication during the study or has received anticoagulant or antiplatelet medication (except for ≤ 150 mg aspirin daily) within 7 days before injection of study drug.
  7. Has used any of the following for the treatment of EFP on the area to be treated within the timelines identified below or intends to use any of the following at any time during the course of the study:

    1. Liposuction within the treatment areas during the 12-month period before injection of study drug.
    2. Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision) within the treatment areas during the 12-month period before injection of study drug.
    3. Any investigational treatment for EFP/cellulite on treatment areas during the 12-month period before the injection of study drug.
    4. Endermologie® or similar treatments within the treatment areas during the 6-month period before injection of study drug.
    5. Massage therapy within the treatment areas during the 3-month period before injection of study drug.
    6. Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the treatment areas during the 2-week period before injection of study drug.
  8. Has received an investigational drug or treatment within 30 days before injection of study drug.
  9. Has a known systemic allergy to collagenase or any other excipient of study drug.
  10. Has a history of drug or alcohol abuse.
  11. Intends to initiate an intensive sport or exercise program during the study.
  12. Intends to initiate a weight reduction program during the study.
  13. Intends to use tanning spray or tanning booths during the study.
  14. Has previously received any collagenase treatments (eg, Santyl® ointment and/or XIAFLEX/XIAPEX®).
  15. Was a subject in a previous cellulite clinical trial of EN3835: AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, EN3835-202, EN3835-205, EN3835-302, or EN3835-303.
  16. Any other condition(s) that, in the Investigator's opinion, might indicate the subject is unsuitable for the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03632993
Other Study ID Numbers  ICMJE EN3835-209
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Responsible Party Endo Pharmaceuticals
Study Sponsor  ICMJE Endo Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: George Omburo Endo Pharmaceuticals
PRS Account Endo Pharmaceuticals
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP