Safety and Effectiveness of EN3835 in the Treatment of EFP in Women

NCT03329989 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EN3835-205
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 11

Brief Summary

An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.

Conditions

Edematous Fibrosclerotic Panniculopathy; Cellulite

Outcome Measures

Primary Outcomes (1)

• Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders

  Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 2-levels of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 2-level responder is a participant with a reduction in severity of at least 2-levels from Baseline at that particular visit. Number of participants analyzed is determined by observed participants at each visit.

  Day 22, 43, 90, and 180

Secondary Outcomes (2)

• Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders

  Day 22, 43, 90, and 180

• Subject Satisfaction With Cellulite Treatment Assessment at End of Study

  Day 180

Other Outcomes (6)

• Overall Anti-AUX-I Serum Antibody by Visit

  Day 1 to Day 180

• Overall Anti-AUX-I Antibody Log Titer Levels by Visit

  Day 1 to Day 180

• Overall Anti-AUX-II Serum Antibody by Visit

  Day 1 to Day 180

Study Arms (1)

EN3835 Active

EXPERIMENTAL

EN3835 0.84mg (Collagenase Clostridium Histolyticum)

Biological: Collagenase Clostridium Histolyticum

Interventions

Collagenase Clostridium Histolyticum BIOLOGICAL

During 3 treatment visits 12 injections will be given per treatment area

Also known as: Xiaflex

EN3835 Active

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female birth gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign and date an informed consent agreement
• Be a female ≥18 years of age
• At Screening visit, have at least 2 bilateral quadrants with each quadrant having:
• a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and
• a Hexsel CSS score no greater than 13
• At Day 1 visit, have assigned bilateral quadrants with each quadrant having:
• a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and
• a Hexsel CSS score no greater than 13
• Be willing to apply sunscreen to the assigned treatment quadrants before each exposure to the sun while participating in the study (i.e., 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 serum pregnancy test at Screening and a negative urine pregnancy test before injection of study drug and be using a stable and effective contraception method (e.g., 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
• 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 systemic conditions:
• Coagulation disorder
• Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years
• History of keloidal scarring or abnormal wound healing
• Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. Any questions about concurrent diseases should be discussed with the Medical Monitor.
• Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values.
• Has any of the following local conditions in the area to be treated:
• History of lower extremity thrombosis or post-thrombosis syndrome
• Vascular disorder (e.g., varicose veins, telangiectasia) in area to be treated
• Inflammation or active infection
• Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer
• Has a tattoo and/or a mole located within 2 cm of the site of injection
• Requires the following concomitant medications before or during participation in the trial:
• a. Anticoagulant or antiplatelet medication or has received anticoagulant or antiplatelet medication (except for ≤150 mg aspirin daily) within 7 days before injection of study drug
• Has used any of the following for the treatment of EFP on the legs or buttock within the timelines identified below or intends to use any of the following at any time during the course of the study:

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (11)

Endo Clinical Trial Site #1

Scottsdale, Arizona, 85258, United States

Location

Endo Clinical Trial Site #2

Huntington Beach, California, 92647, United States

Location

Endo Clinical Trial Site #3

San Diego, California, 92121, United States

Location

Endo Clinical Trial Site #4

Santa Monica, California, 90404, United States

Location

Endo Clinical Trial Site #5

Coral Gables, Florida, 33146, United States

Location

Endo Clinical Trial Site #6

Tampa, Florida, 33626, United States

Location

Endo Clinical Trial Site #7

West Palm Beach, Florida, 33401, United States

Location

Endo Clinical Trial Site #8

Alpharetta, Georgia, 30022, United States

Location

Endo Clinical Trial Site #9

New York, New York, 10003, United States

Location

Endo Clinical Trial Site #10

Franklin, Tennessee, 37067, United States

Location

Endo Clinical Trial Site #11

Austin, Texas, 78746, 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: Saji Vijayan, MBBS
• Organization: Endo Pharmaceuticals

ClinicalTrials@Endo.com

800-462-3636

Study Officials

• Mike McLane, PhD

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: November 17, 2017
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: December 29, 2020
• Results First Posted: November 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)