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

NCT03446781 | Completed Phase 3 Results FDA Drug

• 1 other identifier: EN3835-303
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 25

Brief Summary

Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed, subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days 1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the buttocks will be at the discretion of the Investigator. End of study will occur at study day 71.

Conditions

Edematous Fibrosclerotic Panniculopathy (Cellulite)

Outcome Measures

Primary Outcomes (1)

• 2-level Composite Responders for the Target Buttock

  Proportion of 2-level Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) / Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) composite responders in the target buttock at Day 71. CR-PCSS and PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is defined as a participant with improvement from baseline of at least 2-levels of severity in the CR-PCSS and an improvement from baseline of at least 2-levels of severity in the PR-PCSS of the target buttock. A participant who missed one or two assessments of CR-PCSS and PR-PCSS at Day 71 was defined as a non-responder.

  Day 71

Secondary Outcomes (10)

• 1-level PR-PCSS Responders of the Target Buttock

  Day 71

• 2-level PR-PCSS Responders of the Target Buttock

  Day 71

• 1-level Composite Responders of the Target Buttock

  Day 71

• 2-level Composite Responders of the Non-target Buttock

  Day 71

• 1-level SSRS Responders

  Day 71

Other Outcomes (3)

• Serum Antibody Positivity by Visit

  Day 1 - Day 71

• Overall Antibody Titer Levels by Visit

  Day 1 - Day 71

• Presence of Neutralizing Antibody (Seropositivity) at Day 71 (LOCF) by Antidrug Antibody Log Titer Quartiles

  Day 71

Study Arms (2)

EN3835 Active

ACTIVE COMPARATOR

EN3835 0.84mg (Collagenase Clostridium Histolyticum)

Biological: EN3835

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

EN3835 BIOLOGICAL

Collagenase clostridium histolyticum

EN3835 Active

Placebo BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• 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 2 bilateral buttocks with each buttock having:
• 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)
• At Day 1 visit, have 2 bilateral buttocks with each buttock having:
• 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)
• Be willing to apply sunscreen to the buttocks 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 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 (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
• 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 areas to be treated:
• History of lower extremity thrombosis or post-thrombosis syndrome
• Vascular disorder (eg, varicose veins, telangiectasia) in area to be treated
• Inflammation or active infection
• Severe skin laxity, flaccidity, and/or sagging
• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (25)

Endo Clinical Trial Site #1

Glendale, Arizona, 85308, United States

Location

Endo Clinical Trial Site #2

North Little Rock, Arkansas, 72116, United States

Location

Endo Clinical Trial Site #3

Beverly Hills, California, 90210, United States

Location

Endo Clinical Trial Site #4

Murrieta, California, 92562, United States

Location

Endo Clinical Trial Site #5

Newport Beach, California, 92663, United States

Location

Endo Clinical Trial Site #6

San Diego, California, 92121, United States

Location

Endo Clinical Trial Site #7

Greenwood Village, Colorado, 80111, United States

Location

Endo Clinical Trial Site #8

Coral Gables, Florida, 33146, United States

Location

Endo Clinical Trial Site #9

Miami, Florida, 33137, United States

Location

Endo Clinical Trial Site #10

Nampa, Idaho, 83651, United States

Location

Endo Clinical Trial Site #11

Carmel, Indiana, 46032, United States

Location

Endo Clinical Trial Site #12

Metairie, Louisiana, 70006, United States

Location

Endo Clinical Trial Site #13

New Orleans, Louisiana, 70124, United States

Location

Endo Clinical Trial Site #14

Warren, Michigan, 48088, United States

Location

Endo Clinical Trial Site #15

Montclair, New Jersey, 07042, United States

Location

Endo Clinical Trial Site #16

East Setauket, New York, 11733, United States

Location

Endo Clinical Trial Site #17

New York, New York, 10016, United States

Location

Endo Clinical Trial Site #18

Cincinnati, Ohio, 45212, United States

Location

Endo Clinical Trial Site #19

Nashville, Tennessee, 37215, United States

Location

Endo Clinical Trial Site #20

Austin, Texas, 78759, United States

Location

Endo Clinical Trial Site #21

Beaumont, Texas, 77701, United States

Location

Endo Clinical Trial Site #22

Houston, Texas, 77494, United States

Location

Endo Clinical Trial Site #23

San Antonio, Texas, 78229, United States

Location

Endo Clinical Trial Site #24

Salt Lake City, Utah, 84101, United States

Location

Endo Clinical Trial Site #25

Lynchburg, Virginia, 24501, United States

Location

Related Publications (1)

• Kaufman-Janette J, Joseph JH, Kaminer MS, Clark J, Fabi SG, Gold MH, Goldman MP, Katz BE, Peddy K, Schlessinger J, Young VL, Davis M, Hurley D, Liu G, McLane MP, Vijayan S, Bass LS. Collagenase Clostridium Histolyticum-aaes for the Treatment of Cellulite in Women: Results From Two Phase 3 Randomized, Placebo-Controlled Trials. Dermatol Surg. 2021 May 1;47(5):649-656. doi: 10.1097/DSS.0000000000002952.

  PMID: 33840781 DERIVED

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Saji Vijayan, MBBS
• Organization: Endo Pharmaceuticals

ClinicalTrials@Endo.com

800-462-3636

Study Officials

• Michael McLane

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: February 27, 2018
• Study Start: February 8, 2018
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

US (25)