NCT02724644 - EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) | Crick | Crick

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

Phase 2CompletedNCT02724644

Endo Pharmaceuticals375 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

375

Conditions

Edematous Fibrosclerotic Panniculopathy Cellulite

Interventions

COLLAGENASE CLOSTRIDIUM HISTOLYTICUMBIOLOGICAL

Injectable intervention

Placebo ComparatorBIOLOGICAL

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (16)

Clinical Testing of Beverly Hills

Beverly Hills, California, United States

Dermatology Specialists, Inc

Murrieta, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Day 71

Secondary Outcomes

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

Percentage of composite responders defined as subjects with improvement from baseline of at least 1-level 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 1-level improvement on each scale for example would represent a change from a 4 (severe) to a 3 (moderate). In order to be considered a responder a subject needs to have at least a 1-level improvement on both scales.

Time frame: Baseline, Day 71

CR-PCSS Responder Analysis: 2-Levels of Severity

Percentage of subjects with improvement from baseline of at least 2-levels of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.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). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).

Data from ClinicalTrials.gov

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