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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-18

Study Completion Date

2019-01-24

Brief Summary

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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).

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Detailed Description

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Conditions

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Edematous Skin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment I: CCH Shallow Injection, 3 Aliquots

In Treatment I, CCH will be injected subcutaneously while the participant lies in a prone position. Each injection will consist of a single skin injection of study drug administered as three 0.1 milliliters (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 participant per treatment visit = up to 1.68 milligrams (mg) of CCH (0.84 mg in each treatment area).

Group Type ACTIVE_COMPARATOR

collagenase clostridium histolyticum (CCH)

Intervention Type DRUG

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 (for example, dermal septa) at the site of injection and does not require systemic exposure to be effective.

Treatment II: CCH Shallow Injection, 1 Aliquot

In Treatment II, CCH will be injected subcutaneously while the participant 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 participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).

Group Type ACTIVE_COMPARATOR

collagenase clostridium histolyticum (CCH)

Intervention Type DRUG

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 (for example, dermal septa) at the site of injection and does not require systemic exposure to be effective.

Treatment III: CCH Deep Injection, 1 Aliquot

In Treatment III, CCH will be injected subcutaneously while the participant 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 participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).

Group Type ACTIVE_COMPARATOR

collagenase clostridium histolyticum (CCH)

Intervention Type DRUG

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 (for example, dermal septa) at the site of injection and does not require systemic exposure to be effective.

Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots

In Treatment IV, CCH will be injected subcutaneously while the participant 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 1.5 mL of CCH (5 aliquots of 0.3 mL, for each injection, in each syringe). Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).

Group Type ACTIVE_COMPARATOR

collagenase clostridium histolyticum (CCH)

Intervention Type DRUG

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 (for example, dermal septa) at the site of injection and does not require systemic exposure to be effective.

Treatment V: CCH Shallow Injections, 4 Aliquots

In Treatment V, CCH will be injected subcutaneously while the participant 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 1.2 mL of CCH (4 aliquots of 0.3 mL each). Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).

Group Type ACTIVE_COMPARATOR

collagenase clostridium histolyticum (CCH)

Intervention Type DRUG

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 (for example, dermal septa) at the site of injection and does not require systemic exposure to be effective.

Interventions

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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 (for example, dermal septa) at the site of injection and does not require systemic exposure to be effective.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

No participant will be assigned to treatment until all eligibility criteria have been satisfied. To qualify for the study a participant 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 centimeters (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 (that is, 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 (for example, 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

Participants 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 participant's well-being.
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 (for example, 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 (for example, 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 (for example, 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 (for example, Santyl® ointment and/or XIAFLEX/XIAPEX®).
15. Was a participant 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 participant is unsuitable for the study.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes