Clinical trial NCT02724644: EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Official title: EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Edematous Fibrosclerotic Panniculopathy
Cellulite
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-03-31
Enrollment: 375
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Composite Responders of at Least 2-Level Improvement of Severity
timeFrame: Baseline, Day 71
Secondary outcomes:
measure: Percentage of Composite Responders of at Least 1-Level Improvement of Severity
timeFrame: Baseline, Day 71
measure: CR-PCSS Responder Analysis: 2-Levels of Severity
timeFrame: Baseline, Day 71
measure: CR-PCSS Responder Analysis: 1-Level of Severity
timeFrame: Baseline, Day 71
measure: CR-PCSS Change From Baseline
timeFrame: Baseline, Day 71
measure: PR-PCSS Responder Analysis: 2-Levels of Severity
timeFrame: Baseline, Day 71
measure: PR-PCSS Responder Analysis: 1-Level of Severity
timeFrame: Baseline, Day 71
measure: PR-PCSS Change From Baseline
timeFrame: Baseline, Day 71
measure: Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
timeFrame: Day 71
measure: Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
timeFrame: Day 71
measure: Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale
timeFrame: Day 71
measure: Change in the Hexsel Cellulite Severity Scale (CSS) Total Score
timeFrame: Baseline, Day 71
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Clinical Testing of Beverly Hills
state: California
city: Murrieta
country: United States
facility: Dermatology Specialists, Inc
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc
state: California
city: San Diego
country: United States
facility: Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc
state: California
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute LLC
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast
state: Florida
city: Washington
country: United States
facility: Mercy Health Research
state: Missouri
city: New York
country: United States
facility: Bass Plastic Surgery, PLLC
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center LLC
state: Virginia
city: Lynchburg
country: United States
facility: The Education & Research Foundation
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
References: