EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

Endo Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Cellulite; Edematous Fibrosclerotic Panniculopathy

Treatments: Biological: Placebo Comparator; Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Study type: Interventional

Funder types: Industry

Identifiers

NCT02724644

EN3835-201

Details and patient eligibility

About

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).

Enrollment: 375 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be a female ≥18 years of age

• At Screening visit, have at least 1 quadrant with:

  • a score of 3 or 4 (moderate or severe) as reported by the subject (PR- PCSS), and
  • a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and
  • a Hexsel CSS score no greater than 13

• At Day 1 visit, have an assigned quadrant with:

  • a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
  • a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and
  • a Hexsel CSS score no greater than 13

• 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:

  • Thyroid disease, unless controlled with medication for ≥6 months
  • Uncontrolled diabetes mellitus, as determined by the Investigator
  • Uncontrolled hypertension, as determined by the Investigator
  • Vascular disorder (eg, phlebitis or varicose veins) in area to be treated
  • Cushing's disease and/or use of systemic corticosteroids at a total daily dose greater than 5 mg prednisone (or equivalent)
  • History of lower extremity thrombosis or post-thrombosis syndrome
  • Documented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis
  • Inflammation or active infection in area to be treated
  • Active cutaneous alteration in area to be treated including rash, eczema, psoriasis or skin cancer
  • History of keloidal scarring or abnormal wound healing
  • Coagulation disorder
  • Taking a medication for chronic anticoagulation (except for ≤150 mg aspirin daily)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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375 participants in 2 patient groups, including a placebo group

EN3835 Active

Experimental group

Description:

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.

Treatment:

Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

EN3835 Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo Comparator