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

NCT02724644 | Completed Phase 2 Results

• 1 other identifier: EN3835-201
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 16

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).

Conditions

Edematous Fibrosclerotic Panniculopathy; Cellulite

Outcome Measures

Primary Outcomes (1)

• Percentage of Composite Responders of at Least 2-Level Improvement of Severity

  Percentage of composite responders defined as subjects with an improvement from baseline of at least 2-levels of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement on each scale for example would represent a change from a 4 (severe) to a 2 (mild). In order to be considered a responder a subject needs to have at least a 2-level improvement on both scales.

  Baseline, Day 71

Secondary Outcomes (11)

• Percentage of Composite Responders of at Least 1-Level Improvement of Severity

  Baseline, Day 71

• CR-PCSS Responder Analysis: 2-Levels of Severity

  Baseline, Day 71

• CR-PCSS Responder Analysis: 1-Level of Severity

  Baseline, Day 71

• CR-PCSS Change From Baseline

  Baseline, Day 71

• PR-PCSS Responder Analysis: 2-Levels of Severity

  Baseline, Day 71

Study Arms (2)

EN3835 Active

EXPERIMENTAL

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.

Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

EN3835 Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo Comparator

Interventions

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM BIOLOGICAL

Injectable intervention

Also known as: Xiaflex

EN3835 Active

Placebo Comparator BIOLOGICAL

EN3835 Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (16)

Clinical Testing of Beverly Hills

Beverly Hills, California, 90210, United States

Location

Dermatology Specialists, Inc

Murrieta, California, 92562, United States

Location

Dermatology Specialists, Inc

Oceanside, California, 92056, United States

Location

Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc

San Diego, California, 92121, United States

Location

Olympian Clinical Research

Clearwater, Florida, 33756, United States

Location

Skin Research Institute LLC

Coral Gables, Florida, 33146, United States

Location

Research Institute of the Southeast

West Palm Beach, Florida, 33401, United States

Location

Mercy Health Research

Washington, Missouri, 10075, United States

Location

Bass Plastic Surgery, PLLC

New York, New York, 10065, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Charlottesville Medical Research Center LLC

Charlottesville, Virginia, 22911, United States

Location

The Education & Research Foundation

Lynchburg, Virginia, 24501, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Cellulite

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals Inc.

clinicalsite.inquires@endo.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 31, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 6, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

US (16)