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

Cellulite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724644
• Other study ID #: EN3835-201
• Status: Completed
• Phase: Phase 2
• First received: March 10, 2016
• Last updated: October 4, 2017
• Start date: February 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2017
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cellulite
• Edema
• Edematous Fibrosclerotic Panniculopathy

Intervention

Biological:
• COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Injectable intervention
• Placebo Comparator

Locations

Country	Name	City	State
United States	Clinical Testing of Beverly Hills	Beverly Hills	California
United States	Charlottesville Medical Research Center LLC	Charlottesville	Virginia
United States	Olympian Clinical Research	Clearwater	Florida
United States	Skin Research Institute LLC	Coral Gables	Florida
United States	Dermatology Consulting Services	High Point	North Carolina
United States	The Education & Research Foundation	Lynchburg	Virginia
United States	Dermatology Specialists, Inc	Murrieta	California
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Bass Plastic Surgery, PLLC	New York	New York
United States	Sadick Research Group	New York	New York
United States	Dermatology Specialists, Inc	Oceanside	California
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc	San Diego	California
United States	Premier Clinical Research	Spokane	Washington
United States	Mercy Health Research	Washington	Missouri
United States	Research Institute of the Southeast	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, Day 71
Secondary	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).	Baseline, Day 71
Secondary	CR-PCSS Responder Analysis: 1-Level of Severity	Percentage of subjects with improvement from baseline of at least 1-level 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 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).	Baseline, Day 71
Secondary	CR-PCSS Change From Baseline	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). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.	Baseline, Day 71
Secondary	PR-PCSS Responder Analysis: 2-Levels of Severity	Percentage of subjects with improvement from baseline of at least 2-levels of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject 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).	Baseline, Day 71
Secondary	PR-PCSS Responder Analysis: 1-Level of Severity	Percentage of subjects with improvement from baseline of at least 1-level of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).	Baseline, Day 71
Secondary	PR-PCSS Change From Baseline	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). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.	Baseline, Day 71
Secondary	Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)	On Day 71, the Investigator determined the degree of improvement from baseline in the treated area using the 7-point I-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3).	Day 71
Secondary	Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)	At Day 71, subjects were asked to rate their opinion of the overall improvement of their treated area using the 7-point S-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3)	Day 71
Secondary	Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale	At Day 71, subjects were asked to rate their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings could be satisfied (+1), very satisfied (+2), neither satisfied nor dissatisfied (0), or dissatisfied (-1), very dissatisfied (-2).	Day 71
Secondary	Change in the Hexsel Cellulite Severity Scale (CSS) Total Score	Investigator used the Hexsel CSS to assess the severity of cellulite. The total score could range from 0 (no cellulite) to 15 (extremely severe cellulite). Negative change in Hexsel CSS total score indicates an improvement in cellulite severity	Baseline, Day 71